Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

NCT05035212 — Phase 3, Active not recruiting, 38861 participants, Pfizer

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A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS

RegistryNCT05035212, acronym RENOIR
StatusActive not recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: triple, prevention
Enrollment38861 (Actual)
SponsorPfizer (Industry)
ConditionsLower Respiratory Tract Illness
InterventionsRSVpreF, Placebo (Biological)
Datesstart 2021-08-31, primary completion 2027-01-18 (estimated), completion 2027-01-18 (estimated), first posted 2021-09-05, last updated 2026-01-28
Locations263 sites in United States, Argentina, Canada, Finland, Japan, Netherlands, South Africa

Related Papers Related Patents Related Grants Related Experts
All trials for Lower Respiratory Tract Illness All trials of RSVpreF All trials of Placebo

-Summary

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:

* At a dose of 120µg.
* In adults 60 years of age and older.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.

Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:

* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in the United States and Argentina.

Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:

* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 18 months.
* The study will be conducted in Argentina.

Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:

* At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
* Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
* Blood samples will be collected for antibody testing.
* The duration of the study for each participant will be up to approximately 24 months.
* The study will be conducted in the United States and Canada.

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+Arms and interventions

ArmTypeInterventionsDescription
Efficacy Study: RSVpreF vaccineExperimentalBiological: RSVpreFRSVpreF
Efficacy Study: Placebo dosePlacebo comparatorBiological: PlaceboPlacebo
SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)ExperimentalBiological: RSVpreFParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.
SSA: Vaccination of RSVpreF recipients with PlaceboPlacebo comparatorBiological: PlaceboParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.
SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)ExperimentalBiological: RSVpreFParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.
SSB: Vaccination of RSVpreF recipients with PlaceboPlacebo comparatorBiological: PlaceboParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.
SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)ExperimentalBiological: RSVpreFParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive RSVpreF at the Year 3 vaccination followed by placebo at the Year 4 vaccination in SSC.
SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)ExperimentalBiological: RSVpreFParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at the Year 3 vaccination followed by RSVpreF at the Year 4 vaccination in SSC.
SSC: Vaccination of RSVpreF recipients with PlaceboPlacebo comparatorBiological: PlaceboParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at both the Year 3 and Year 4 vaccination in SSC.
  • RSVpreF (Biological): RSV vaccine (RSVpreF)
  • Placebo (Biological): Placebo

+Outcome measures

Primary outcomes

  • Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season [From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
  • Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination [Within 7 days after vaccination]: Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity
  • Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination [Within 7 days after vaccination]: Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
  • Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination [Within 1 month after vaccination (up to 35 days)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
  • Efficacy Study: Proportion of participants reporting SAE throughout the study [Throughout the study duration (an average of 30 months)]: SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Efficacy Study: Proportion of participants reporting NDCMC throughout the study [Throughout the study duration (an average of 30 months)]: An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
  • SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF [Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination [Within 7 days after revaccination]: Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity
  • SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination [Within 7 days after revaccination]: Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
  • SSA: Proportion of participants reporting AE within 1-month after revaccination [Within 1 month after revaccination (up to 35 days)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
  • SSA: Proportion of participants reporting SAE throughout the study [Throughout the study duration (approximately 18 months)]: SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • SSA: Proportion of participants reporting NDCMC throughout the study [Throughout the study duration (approximately 18 months)]: An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
  • SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF [Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination [Within 7 days after revaccination]: Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
  • SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination [SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination]: Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
  • SSB: Proportion of participants reporting AE within 1-month after revaccination [Within 1 month after revaccination (up to 35 days)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
  • SSB: Proportion of participants reporting SAE throughout the study [Throughout the study duration (approximately 18 months)]: SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • SSB: Proportion of participants reporting NDCMC throughout the study [Throughout the study duration (approximately 18 months)]: An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 3) [1 month after revaccination in SSC (Year 3)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 3) [At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 3) [1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 4) [1 month after revaccination in SSC (Year 4)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 4) [At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 4) [1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 3) [Within 7 days after revaccination]: Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
  • SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 4) [Within 7 days after revaccination]: Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
  • SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 3) [Within 7 days after revaccination]: Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
  • SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 4) [Within 7 days after revaccination]: Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
  • SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 3) [Within 1 month after revaccination (up to 35 days)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
  • SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 4) [Within 1 month after revaccination (up to 35 days)]: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
  • SSC: Proportion of participants reporting SAE after revaccination (Year 3) [Following revaccination and throughout the study duration (approximately 24 months)]: SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • SSC: Proportion of participants reporting SAE after revaccination (Year 4) [Following revaccination and throughout the study duration (approximately 12 months)]: SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • SSC: Proportion of participants reporting NDCMC after revaccination (Year 3) [Following revaccination and throughout the study duration (approximately 24 months)]: An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
  • SSC: Proportion of participants reporting NDCMC after revaccination (Year 4) [Following revaccination and throughout the study duration (approximately 12 months)]: An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

Secondary outcomes

  • Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season [From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
  • Efficacy Study: Number of first episode of LRTI-RSV in the second RSV season [During the second RSV season (an average of 6 months)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
  • Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons [From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
  • Efficacy Study: Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season [From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
  • Efficacy Study: Number of first episode of ARI-RSV in the second RSV season [During the second RSV season (an average of 6 months)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
  • Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons [From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
  • Efficacy Study: Number of first episode of sLRTI-RSV in the second RSV season [During the second RSV season (an average of 6 months)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
  • Efficacy Study: Number of first episode of sLRTI-RSV across 2 RSV seasons [From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)]: Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
  • Efficacy Study: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers [Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination)]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSA. [Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSA]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSB [Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSB]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
  • SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSC. [Participants receiving placebo at the Year 3 vaccination: 1 month, 3 and 3.5 years after efficacy study vaccination]: RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

Efficacy Study

Inclusion Criteria:

* Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.

* Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
* Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
* Male or female participants ≥60 years of age.

  * Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
  * Female participants must not be of childbearing potential.

Exclusion Criteria:

* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
* Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3).

Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study - Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.

* Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Substudy A

Inclusion Criteria:

* Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.

* Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
* Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
* Male or female participants ≥60 years of age.

  * Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
  * Female participants must not be of childbearing potential.
* Participants who received RSVpreF in the efficacy study.
* Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration.

Exclusion Criteria:

* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
* Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 103).

Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study

\- Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.

* Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.

Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy A.

* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
* Participant was confirmed by the sponsor to have previously received the study intervention more than once.

Substudy B

Inclusion Criteria:

* Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.

* Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
* Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
* Male or female participants ≥60 years of age.

  * Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
  * Female participants must not be of childbearing potential. 6. Participants who received RSVpreF in the efficacy study.
* Participants who received RSVpreF in the efficacy study.
* Participants who have a Visit 2 serology sample available for testing from the efficacy study and did not meet exclusion criteria through Visit 4 of the efficacy study.

Exclusion Criteria:

* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
* Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 203).

Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study - Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.

* Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.

Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy B.

* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
* Participant was confirmed by the sponsor to have previously received the study intervention more than once.
* Participants who completed Vaccination 1 from the efficacy study less than 9 months or greater than 15 months prior to revaccination.

Substudy C

Inclusion Criteria:

* Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, when indicated.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.

* Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
* Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
* Male or female participants ≥60 years of age.
* Participants who received RSVpreF in the efficacy study.
* Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration.

Exclusion Criteria:

* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
* Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 303 or Visit 306).

Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study

\- Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.

* Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.

Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy C.

* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
* Participant was confirmed by the sponsor to have previously received the study intervention more than once.
* Prior history of any subtype of Guillain-Barré syndrome of any etiology.
* Current or prior participation in Substudy A or Substudy B.
* Participants who completed Vaccination 1 from the efficacy study less than 32 months or greater than 40 months prior to revaccination.

+Locations (263)

FacilityCityCountryStatus
St. Vincent's Birmingham (Pharmacy)Birmingham, AlabamaUnited States
St. Vincent's BirminghamBirmingham, AlabamaUnited States
Medical Affiliated Research CenterHuntsville, AlabamaUnited States
Lenzmeier Family Medicine / AvacareGlendale, ArizonaUnited States
Phoenix Clinical LLCPhoenix, ArizonaUnited States
HOPE Research InstitutePhoenix, ArizonaUnited States
The Pain Center of ArizonaPhoenix, ArizonaUnited States
HOPE Research InstitutePhoenix, ArizonaUnited States
Cognitive Clinical Trials, LLCPhoenix, ArizonaUnited States
Headlands Research - ScottsdaleScottsdale, ArizonaUnited States
Alliance for Multispecialty Research, LLCTempe, ArizonaUnited States
HOPE Research InstituteTempe, ArizonaUnited States
Noble Clinical ResearchTucson, ArizonaUnited States
The Institute for Liver Health dba Arizona Clinical TrialsTucson, ArizonaUnited States
Hope Clinical ResearchCanoga Park, CaliforniaUnited States
eStudySiteChula Vista, CaliforniaUnited States
Benchmark ResearchColton, CaliforniaUnited States
West Coast ResearchDublin, CaliforniaUnited States
Marvel Clinical Research 002, LLCHuntington Beach, CaliforniaUnited States
Chemidox Clinical TrialsLancaster, CaliforniaUnited States
Ark Clinical ResearchLong Beach, CaliforniaUnited States
Downtown L.A. Research Center, Inc.Los Angeles, CaliforniaUnited States
Velocity Clinical Research, North HollywoodNorth Hollywood, CaliforniaUnited States
Clinica mi Salud by Focil MedOxnard, CaliforniaUnited States
De Silva Medical IncPalmdale, CaliforniaUnited States
Empire Clinical ResearchPomona, CaliforniaUnited States
Paradigm Clinical Research CenterRedding, CaliforniaUnited States
Artemis Institute for Clinical ResearchRiverside, CaliforniaUnited States
Benchmark ResearchSacramento, CaliforniaUnited States
Artemis Institute for Clinical ResearchSan Diego, CaliforniaUnited States
California Research FoundationSan Diego, CaliforniaUnited States
Diablo Clinical Research, Inc.Walnut Creek, CaliforniaUnited States
Lynn Institute of DenverAurora, ColoradoUnited States
Tekton Research LLCLongmont, ColoradoUnited States
Clinical Research ConsultingMilford, ConnecticutUnited States
Stamford Therapeutics ConsortiumStamford, ConnecticutUnited States
JEM Research InstituteAtlantis, FloridaUnited States
IDEAL Clinical ResearchAventura, FloridaUnited States
Innovative Research of West FloridaClearwater, FloridaUnited States
Invictus Clinical Research Group, LLCCoconut Creek, FloridaUnited States
Nature Coast Clinical ResearchCrystal River, FloridaUnited States
Universal Axon Clinical Research, LLC (Administrative)Doral, FloridaUnited States
Indago Research & Health Center, IncHialeah, FloridaUnited States
Doral Medical Research, LLCHialeah, FloridaUnited States
M3 Wake Research - Lake CityLake City, FloridaUnited States
Optimus U CorporationMiami, FloridaUnited States
Advance Medical Research CenterMiami, FloridaUnited States
Flourish Research - Miami, LLCMiami, FloridaUnited States
Optimus U CorporationMiami, FloridaUnited States
Next Phase Research AllianceMiami, FloridaUnited States
New Horizon Research CenterMiami, FloridaUnited States
De La Cruz Research Center, LLCMiami, FloridaUnited States
Global Health Research Center, Inc.Miami Lakes, FloridaUnited States
Headlands Research OrlandoOrlando, FloridaUnited States
Pines Care Research Center, LLCPembroke Pines, FloridaUnited States
IDEAL Clinical ResearchPembroke Pines, FloridaUnited States
DBC Research USAPembroke Pines, FloridaUnited States
Headlands Research SarasotaSarasota, FloridaUnited States
Precision Clinical ResearchSunrise, FloridaUnited States
Clinical Site Partners, LLC dba Flourish ResearchWinter Park, FloridaUnited States
Conquest ResearchWinter Park, FloridaUnited States
Javara - Privia Medical Group Georgia - AlbanyAlbany, GeorgiaUnited States
Coastal Heritage Clinical ResearchHinesville, GeorgiaUnited States
Javara - Privia Medical Group Georgia - SavannahSavannah, GeorgiaUnited States
Velocity Clinical Research, SavannahSavannah, GeorgiaUnited States
Clinical Research AtlantaStockbridge, GeorgiaUnited States
Javara Inc.Thomasville, GeorgiaUnited States
Snake River Research, PLLCIdaho Falls, IdahoUnited States
Solaris Clinical ResearchMeridian, IdahoUnited States
Great Lakes Clinical Trials, LLC dba Flourish ResearchChicago, IllinoisUnited States
DM Clinical ResearchMelrose Park, IllinoisUnited States
Affinity Health CorpOak Brook, IllinoisUnited States
Accellacare - DuPageOak Lawn, IllinoisUnited States
MOC ResearchMishawaka, IndianaUnited States
Velocity Clinical Research ValparaisoValparaiso, IndianaUnited States
University of IowaIowa City, IowaUnited States
Meridian Clinical Research, LLCSioux City, IowaUnited States
AMR ClinicalLexington, KentuckyUnited States
Ochsner Clinic FoundationKenner, LouisianaUnited States
Ochsner Medical Center - KennerKenner, LouisianaUnited States
Velocity Clinical Research, MetairieMetairie, LouisianaUnited States
Velocity Clinical Research, RockvilleRockville, MarylandUnited States
ActivMed Practices & Research, LLCBeverly, MassachusettsUnited States
ActivMed Practices & Research, LLCMethuen, MassachusettsUnited States
University of Massachusetts Chan Medical SchoolWorcester, MassachusettsUnited States
Michigan Center of Medical Research (MICHMER)Farmington Hills, MichiganUnited States
Ascension St. John Hospital Vaccine Research UnitGrosse Pointe Woods, MichiganUnited States
Oakland Medical ResearchTroy, MichiganUnited States
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, MichiganUnited States
Saint Louis UniversitySt Louis, MissouriUnited States
Sundance Clinical ResearchSt Louis, MissouriUnited States
Skyline Medical Center, PC/CCT ResearchElkhorn, NebraskaUnited States
Quality Clinical ResearchOmaha, NebraskaUnited States
Wr-Crcn, Llc.Las Vegas, NevadaUnited States
Alliance for Multispecialty Research, LLCLas Vegas, NevadaUnited States
Las Vegas Clinical TrialsNorth Las Vegas, NevadaUnited States
ActivMed Practices and Research, LLC.Portsmouth, New HampshireUnited States
South Jersey Infectious DiseaseSomers Point, New JerseyUnited States
IMA Clinical Research WarrenWarren Township, New JerseyUnited States
Velocity Clinical Research, BinghamtonBinghamton, New YorkUnited States

163 more sites not listed.

+Publications

  • Results publication: Walsh EE, Eiras D, Woodside J, Jiang Q, Patton M, Marc GP, Llapur C, Ramet M, Fukushima Y, Hussen N, Cardona J, Mikati T, Zareba A, Ilangovan K, Lino MM, Kalinina EV, Swanson KA, Gurtman A, Munjal I. Efficacy, Immunogenicity, and Safety of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Vaccine in Older Adults Over 2 RSV Seasons. Clin Infect Dis. 2026 Feb 4;81(6):e680-e689. doi: 10.1093/cid/ciaf061. PMID 39928572
  • Results publication: Walsh EE, Perez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, Polack FP, Llapur C, Doreski PA, Ilangovan K, Ramet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Castillo Villa G, Ingilizova M, Eiras D, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gurtman A, Gruber WC, Schmoele-Thoma B; RENOIR Clinical Trial Group. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023 Apr 20;388(16):1465-1477. doi: 10.1056/NEJMoa2213836. Epub 2023 Apr 5. PMID 37018468

+Investigators

  • Pfizer CT.gov Call Center, Study director, Pfizer