A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older
| Registry | NCT05091307 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: double, prevention |
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| Enrollment | 861 (Actual) |
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| Sponsor | Janssen Vaccines & Prevention B.V. (Industry) |
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| Conditions | COVID-19 Prevention |
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| Interventions | Ad26.COV2.S, Placebo, Influenza Vaccine (Biological, other) |
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| Dates | start 2021-11-02, primary completion 2022-06-17, completion 2022-11-15, first posted 2021-10-25, last updated 2025-05-25 |
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| Locations | 31 sites in United States, Belgium, Poland |
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Related Papers Related Patents Related Grants Related Experts
All trials for COVID-19 Prevention All trials of Ad26.COV2.S All trials of Placebo
-Summary
The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.
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+Detailed description
Severe acute respiratory syndrome coronavirus(-2) (SARS CoV-2) is a highly transmissible and pathogenic coronavirus that has spread rapidly and globally and Influenza is a worldwide public health problem, responsible for significant morbidity and mortality. Ad26.COV2.S (also known as VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode SARS-CoV-2 spike (S) protein, stabilized in its prefusion conformation. The seasonal influenza vaccines to be used in this study are quadrivalent (standard dose) and quadrivalent (high-dose) or equivalent formulated. The aim is to demonstrate the concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent influenza vaccine (standard-dose) is non-inferior than the administration of either seasonal quadrivalent influenza vaccine (standard-dose) alone as measured by HI titers against each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent seasonal influenza vaccine or Ad26.COV2.S vaccine alone as measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) antibody titers at 28 days after the administration of the Ad26.COV2.S vaccine. This study consists of 3 phases: screening phase (Day -28 to 1), treatment phase (vaccination visits on Days 1 and 29), and a follow-up phase (28 days after each vaccination). Some of safety assessments will include physical examination, vital signs, clinical safety laboratory assessments, pregnancy testing, monitoring of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI). The total duration of the study is up to 7-8 months.
Note: The Informed Consent Form dated 25-Mar-2022 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees. And the highlighted text in the ICF document are the guidance for country specific adaptation.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and Placebo | Experimental | Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine | Participants aged greater than or equal to (>=) 18 years will receive a single intramuscular (IM) injection of Ad26.COV2.S and a seasonal Q SD influenza vaccine on Day 1 and placebo on Day 29. |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Placebo comparator | Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine | Participants aged >=18 years will receive a single IM injection of placebo and a seasonal Q SD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29. |
| Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and Placebo | Experimental | Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine | Participants aged >=65 years will receive a single IM injection of Ad26.COV2.S and a seasonal Q HD influenza vaccine on Day 1 followed by placebo on Day 29. |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Placebo comparator | Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine | Participants aged >=65 years will receive a single IM injection of placebo and a seasonal Q HD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29. |
- Ad26.COV2.S (Biological), also known as VAC31518, JNJ-78436735: Ad26.COV2.S will be administered as an IM injection.
- Placebo (Other): Placebo will be administered as an IM injection.
- Influenza Vaccine (Biological): Influenza vaccine high and standard dose will be administered as IM injection.
+Outcome measures
Primary outcomes
- Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine [28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)]: GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only. PPII=Per-protocol influenza immunogenicity.
- Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine [28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57)]: GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and major protocol deviation were excluded from PPSI analysis.
Secondary outcomes
- Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination [7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)]: An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
- Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination [7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)]: An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after each vaccination.
- Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination [28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57)]: An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
- Number of Participants With Serious Adverse Events (SAEs) [From Day 1 (post-vaccination) to end of the study (up to 12.5 months)]: An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE was any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
- Number of Participants With Medically-attended Adverse Events (MAAEs) [From Day 1 (post-vaccination) to end of the study (up to 12.5 months)]: Number of participants with MAAEs was reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. New onset of chronic diseases was collected as part of the MAAEs.
- Number of Participants With Adverse Events of Special Interest (AESIs) [From Day 1 (post-vaccination) to end of the study (up to 12.5 months)]: Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.
- Number of Participants With AEs Leading to Withdrawal From the Study [From Day 1 (post-vaccination) to end of the study (up to 12.5 months)]: Number of participants with AE leading to withdrawal from the study was reported.
- Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine [28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29)]: GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Tasmania\[H3N2\], B/Washington \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only.
- Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine [28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57)]: GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for SARSCoV-2 and major protocol deviation were excluded from PPSI analysis.
- GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants [28 days after the administration of Ad26.COV2.S vaccine (that is, for Groups 1 and 3: Day 29; for Groups 2 and 4: Day 57)]: GMCs of antibodies measured by S-ELISA 28 days after administration of Ad26.COV.S vaccine in Covid-19 vaccine naive participants was reported. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
- Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine [28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)]: Seroconversion was defined for each of the 4 influenza vaccine strains (For group 1 and 2: A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\], B/Phuket \[B/Yamagata\]; For group 3 and 4: A/Victoria \[H1N1\], B/Phuket (B/Yamagata), A/Tasmania \[H3N2\], B/Washington \[B/Victoria\]) at 28 days after the administration of a seasonal quadrivalent (high-dose and standard-dose) influenza vaccine: HI titer greater than or equal to (>=) 1:40 in participants with a pre-vaccination HI titer of less than (<) 1:10, or a >=4-fold HI titer increase in participants with a pre-vaccination HI titer of >= 1:10. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
- Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine [28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)]: Seroprotection was defined for each of the 4 influenza vaccine strains (For group 1 and 2: A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\], B/Phuket \[B/Yamagata\]; For group 3 and 4: A/Victoria \[H1N1\], B/Phuket (B/Yamagata), A/Tasmania \[H3N2\], B/Washington \[B/Victoria\]) as HI titer >=1:40 at 28 days after the administration of a seasonal quadrivalent (high-dose and standard-dose) influenza vaccine. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.
+Eligibility
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria:
* Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participants may have underlying illnesses, as long as the symptoms and signs are medically controlled
* Participant either received complete primary vaccination with an authorized/licensed coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to \[>=\] 6 months prior to the last vaccination received against COVID-19) or is COVID-19 vaccine-naive
* All participants who were born female and are of childbearing potential must: a. Have a negative highly sensitive urine pregnancy test at screening, b. Have a negative highly sensitive urine pregnancy test on the day of vaccination prior to each study vaccine administration
* Participant agrees to not donate or receive bone marrow, blood, and blood products from the administration of the study vaccine until 3 months after receiving the study vaccines
* Participant must be willing to provide verifiable identification to be contacted and to contact the investigator during the study
Exclusion Criteria:
* Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancies considered cured with minimal risk of recurrence per investigator's clinical judgment)
* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit \[°F\]) within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
* Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
* Participant has history of capillary leak syndrome
* Participant received a licensed/registered severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study vaccination (other than study vaccination)
* Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
+Posted results
Participant flow
| Milestone | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S |
|---|
| Started | 382 | 386 | 47 | 46 |
| Treated | 382 | 384 | 47 | 46 |
| Completed | 312 | 316 | 43 | 44 |
| Not completed | 70 | 70 | 4 | 2 |
Outcome results
- Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine (Primary), Geometric mean, Titers: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 306 (271 to 346); Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 393 (348 to 445)
- Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine (Primary), Geometric mean, ELISA Unit per milliliter (EU/mL): Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 22531 (20140 to 25205); Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 25035 (22189 to 28246)
- Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 261; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 204; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 23; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 21
- Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 256; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 205; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 30; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 26
- Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 71; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 71; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 10; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 9
- Number of Participants With Serious Adverse Events (SAEs) (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 9; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 7; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 1; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 2
- Number of Participants With Medically-attended Adverse Events (MAAEs) (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 51; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 51; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 11; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 16
- Number of Participants With Adverse Events of Special Interest (AESIs) (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 9; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 12; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 0; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 0
- Number of Participants With AEs Leading to Withdrawal From the Study (Secondary), Count of participants, Participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 0; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 0; Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 0; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 0
- Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine (Secondary), Geometric mean, Titers: Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 286 (204 to 400); Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 484 (369 to 636)
- Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine (Secondary), Geometric mean, EU/mL: Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 17569 (13391 to 23051); Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 20743 (12732 to 33794)
- GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants (Secondary), Geometric mean, EU/mL: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 10340 (6557 to 16306); Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 14704 (9010 to 23998); Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo ; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 38905 (NA to NA)
- Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine (Secondary), Number, Percentage of participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 64.1 (58.5 to 69.3); Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 70.0 (64.7 to 74.8); Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 65.1 (49.1 to 79.0); Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 70.7 (54.5 to 83.9)
- Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine (Secondary), Number, Percentage of participants: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo 97.8 (95.5 to 99.1); Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S 97.3 (94.9 to 98.8); Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo 100.0 (91.8 to 100.0); Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S 100.0 (91.4 to 100.0)
Adverse events
Time frame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 0/382 (0.0%) | 9/382 (2.4%) | 45/382 (11.8%) |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 0/384 (0.0%) | 7/384 (1.8%) | 45/384 (11.7%) |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 1/47 (2.1%) | 1/47 (2.1%) | 11/47 (23.4%) |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 0/46 (0.0%) | 2/46 (4.3%) | 6/46 (13.0%) |
Serious adverse events by term
| Term | Organ system | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S |
|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 1/382 | 1/384 | 0/47 | 0/46 |
| Cardiac Arrest | Cardiac disorders | 0/382 | 0/384 | 1/47 | 0/46 |
| Chronic Left Ventricular Failure | Cardiac disorders | 0/382 | 1/384 | 0/47 | 0/46 |
| Biliary Obstruction | Hepatobiliary disorders | 1/382 | 0/384 | 0/47 | 0/46 |
| Covid-19 | Infections and infestations | 0/382 | 1/384 | 0/47 | 0/46 |
| Staphylococcal Infection | Infections and infestations | 1/382 | 0/384 | 0/47 | 0/46 |
| Fibula Fracture | Injury, poisoning and procedural complications | 1/382 | 0/384 | 0/47 | 0/46 |
| Joint Injury | Injury, poisoning and procedural complications | 1/382 | 0/384 | 0/47 | 0/46 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 0/382 | 0/384 | 0/47 | 1/46 |
| Gastrointestinal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/382 | 1/384 | 0/47 | 0/46 |
| Polycythaemia Vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/382 | 0/384 | 0/47 | 0/46 |
| Optic Neuritis | Nervous system disorders | 0/382 | 1/384 | 0/47 | 0/46 |
| Bipolar Disorder | Psychiatric disorders | 1/382 | 0/384 | 0/47 | 0/46 |
| Calculus Urinary | Renal and urinary disorders | 0/382 | 0/384 | 0/47 | 1/46 |
| Abnormal Uterine Bleeding | Reproductive system and breast disorders | 1/382 | 0/384 | 0/47 | 0/46 |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | 0/382 | 1/384 | 0/47 | 0/46 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 0/382 | 1/384 | 0/47 | 0/46 |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | 0/382 | 1/384 | 0/47 | 0/46 |
| Skin Ulcer | Skin and subcutaneous tissue disorders | 1/382 | 0/384 | 0/47 | 0/46 |
| Deep Vein Thrombosis | Vascular disorders | 1/382 | 0/384 | 0/47 | 0/46 |
Other adverse events by term
| Term | Organ system | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S |
|---|
| Covid-19 | Infections and infestations | 42/382 | 42/384 | 10/47 | 5/46 |
| Nasopharyngitis | Infections and infestations | 3/382 | 5/384 | 2/47 | 3/46 |
+Locations (31)
| Facility | City | Country | Status |
|---|
| Fiel Family and Sports Medicine Clinical Research Advantage | Tempe, Arizona | United States | |
| Wr McCr Llc | San Diego, California | United States | |
| Clinical Research of South Florida, an AMR Company | Coral Gables, Florida | United States | |
| AMR Fort Myers Clinical Physiology Associates, an AMR company | Fort Myers, Florida | United States | |
| Office of Emilio Mantero-Atienza, MD | Miami, Florida | United States | |
| University of Miami Health System | Miami, Florida | United States | |
| Premier Research Associate, Inc | Miami, Florida | United States | |
| Medisphere Medical Research Center, Llc | Evansville, Indiana | United States | |
| Meridian Clinical Research, LLC | Norfolk, Nebraska | United States | |
| Clinical Research Consortium, an AMR company | Las Vegas, Nevada | United States | |
| I.D. Care, Inc. | Hillsborough, New Jersey | United States | |
| Rochester Clinical Research, Inc | Rochester, New York | United States | |
| Carolina Institute for Clinical Research | Fayetteville, North Carolina | United States | |
| Coastal Carolina Research Center | North Charleston, South Carolina | United States | |
| Ventavia Research Group, LLC | Keller, Texas | United States | |
| Research Your Health | Plano, Texas | United States | |
| Clinical Research Partners, LLC | Richmond, Virginia | United States | |
| Anima | Alken | Belgium | |
| Institute of Tropical Medicine Antwerp | Antwerp | Belgium | |
| Clinical Pharmacology Unit | Merksem | Belgium | |
| Private Practice RESPISOM Namur | Namur | Belgium | |
| Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Częstochowa | Poland | |
| Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | Poland | |
| Gdanskie Centrum Zdrowia | Gdansk | Poland | |
| Synexus Polska Sp. z o.o. Oddzial w Gdynia | Gdynia | Poland | |
| Synexus Polska Sp z o o Oddzial w Katowicach | Katowice | Poland | |
| Synexus Polska Sp Z O O Oddzial W Lodzi | Lodz | Poland | |
| Synexus Polska Sp. z.o.o. Oddzial w Poznaniu | Poznan | Poland | |
| Centrum Medyczne Pratia Poznan | Skorzewo | Poland | |
| Synexus Polska Sp z o o Oddzial w Warszawie | Warsaw | Poland | |
| Synexus Polska Sp z o o Oddzial we Wroclawiu | Wroclaw | Poland | |
+Publications
- Results publication: Tapia-Calle G, Aguilar G, Vaissiere N, Truyers C, Ylisastigui P, Buntinx E, Le Gars M, Struyf F, Scheper G, Douoguih M, Ruiz-Guinazu J; COV3005 Study group. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial. EClinicalMedicine. 2025 Jan 7;79:103016. doi: 10.1016/j.eclinm.2024.103016. eCollection 2025 Jan. PMID 39866854
+Study documents
+Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.