Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

NCT03893448 — Phase 3, Completed, 1720 participants, Merck Sharp & Dohme LLC

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

Registry	NCT03893448, acronym PNEU-PED
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	1720 (Actual)
Sponsor	Merck Sharp & Dohme LLC (Industry)
Conditions	Pneumococcal Infections, Pneumococcal Vaccines
Interventions	V114, Prevnar 13™, RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, MMR II™, VARIVAX™, HIBERIX™ (Biological)
Dates	start 2019-06-19, primary completion 2021-05-24, completion 2021-05-24, first posted 2019-03-28, last updated 2023-07-28
Locations	81 sites in United States, Puerto Rico, Thailand, Turkey (Türkiye)

-Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

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+Arms and interventions

Arm	Type	Interventions	Description
V114	Experimental	Biological: V114; Biological: RotaTeq™; Biological: Pentacel™; Biological: RECOMBIVAX HB™; Biological: VAQTA™; Biological: MMR II™; Biological: VARIVAX™; Biological: HIBERIX™	Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
Prevnar 13™	Active comparator	Biological: Prevnar 13™; Biological: RotaTeq™; Biological: Pentacel™; Biological: RECOMBIVAX HB™; Biological: VAQTA™; Biological: MMR II™; Biological: VARIVAX™; Biological: HIBERIX™	Participants receive 4 total 0.5 mL IM vaccinations at \~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.

V114 (Biological), also known as VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine: V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
Prevnar 13™ (Biological): Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
RotaTeq™ (Biological): A total of 3 RotaTeq™ 2 mL oral dosings at \~2, \~4, and \~6 months of age.
Pentacel™ (Biological): A total of 3 Pentacel™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
RECOMBIVAX HB™ (Biological): A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
VAQTA™ (Biological): One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
MMR II™ (Biological): One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
VARIVAX™ (Biological): One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
HIBERIX™ (Biological): One HIBERIX™ 0.5 mL IM dosing at Visit 5.

+Outcome measures

Primary outcomes

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ [Up to 14 days after each vaccination with either V114 or Prevnar 13™]: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Percentage of Participants With Solicited Systemic AEs [Up to 14 days after each vaccination with either V114 or Prevnar 13™]: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) [From Day 1 up to 6 months after Vaccination 4 (up to 21 months)]: An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
GMC of Anti-PnP IgG Ab One Month After Vaccination 4 [One month after Vaccination 4 (Month 13 to Month 16)]: The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.

Secondary outcomes

Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Pertussis antibody GMCs were measured using Luminex Assay.
Hepatitis A Antibody Response Rate One Month After Vaccination 4 [One month after Vaccination 4 (Month 13 to Month 16)]: Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 [One month after Vaccination 4 (Month 13 to Month 16)]: Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 [One month after Vaccination 4 (Month 13 to Month 16)]: Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 [One month after Vaccination 4 (Month 13 to Month 16)]: Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes [One month after Vaccination 3 (Month 7)]: Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes [One month after Vaccination 3 (Month 7)]: Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes [One month after Vaccination 4 (Month 13 to Month 16)]: Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [One month after Vaccination 3 (Month 7)]: Serotype 3-specific anti-PnP GMC was measured with PnECL.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 [One month after Vaccination 4 (Month 13 to Month 16)]: Serotype 3-specific anti-PnP GMC were measured with PnECL.

+Eligibility

Sex: All, ages: 42 Days to 90 Days, accepts healthy volunteers

Inclusion Criteria:

* Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
* Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
* Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
* Has any contraindication to the concomitant study vaccines being administered in the study.
* Had a recent febrile illness (rectal temperature ≥38.1°C \[=100.5°F\] or axillary temperature ≥37.8°C \[=100.0°F\]) occurring within 72 hours prior to receipt of study vaccine.

+Posted results

Participant flow

Milestone	V114	Prevnar 13™
Started	860	860
Treated	858	856
Completed	758	734
Not completed	102	126

Outcome results

Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ (Primary), Number, Percentage of participants: V114 69.0; Prevnar 13™ 69.2 (p = 0.039)
Percentage of Participants With Solicited Systemic AEs (Primary), Number, Percentage of participants: V114 84.4; Prevnar 13™ 84.8 (p = 0.446)
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) (Primary), Number, Percentage of participants: V114 0.0; Prevnar 13™ 0.0
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 (Primary), Number, Percentage of participants: V114 95.7; Prevnar 13™ 99.1 (p < 0.001)
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 (Primary), Geometric mean, ug/mL: V114 1.21 (1.15 to 1.27); Prevnar 13™ 1.89 (1.79 to 2.00) (p < 0.001)
GMC of Anti-PnP IgG Ab One Month After Vaccination 4 (Primary), Geometric mean, ug/mL: V114 1.35 (1.27 to 1.42); Prevnar 13™ 2.03 (1.92 to 2.14) (p < 0.001)
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 (Secondary), Number, Percentage of participants: V114 96.9; Prevnar 13™ 97.6 (p < 0.001)
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 (Secondary), Geometric mean, ug/mL: V114 43.73 (NA to NA); Prevnar 13™ 44.35 (NA to NA) (p < 0.001)
Hepatitis A Antibody Response Rate One Month After Vaccination 4 (Secondary), Number, Percentage of participants: V114 97.4; Prevnar 13™ 97.1 (p < 0.001)
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 (Secondary), Number, Percentage of participants: V114 98.1; Prevnar 13™ 98.3 (p < 0.001)
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 (Secondary), Number, Percentage of participants: V114 96.4; Prevnar 13™ 97.7 (p < 0.001)
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 (Secondary), Number, Percentage of participants: V114 98.9; Prevnar 13™ 100.0 (p < 0.001)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes (Secondary), Geometric mean, ug/mL: V114 4.91 (4.58 to 5.26); Prevnar 13™ 0.05 (0.05 to 0.06) (p < 0.001)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes (Secondary), Number, Percentage of participants: V114 98.6; Prevnar 13™ 3.5 (p < 0.001)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes (Secondary), Geometric mean, ug/mL: V114 7.52 (7.09 to 7.98); Prevnar 13™ 0.11 (0.10 to 0.12) (p < 0.001)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 (Secondary), Geometric mean, Titers: V114 56.9 (46.1 to 70.3); Prevnar 13™ 78.3 (61.5 to 99.5)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 (Secondary), Number, Percentage of participants: V114 86.5 (80.4 to 91.2); Prevnar 13™ 87.7 (81.6 to 92.3)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 (Secondary), Number, Percentage of participants: V114 94.7; Prevnar 13™ 79.2 (p < 0.001)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 (Secondary), Geometric mean, ug/mL: V114 1.08 (1.03 to 1.14); Prevnar 13™ 0.62 (0.59 to 0.66) (p < 0.001)
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 (Secondary), Geometric mean, ug/mL: V114 0.96 (0.91 to 1.01); Prevnar 13™ 0.71 (0.67 to 0.75) (p < 0.001)

Adverse events

Time frame: Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)

Arm	Deaths	Serious adverse events	Other adverse events
V114	1/860 (0.1%)	88/858 (10.3%)	790/858 (92.1%)
Prevnar 13™	1/859 (0.1%)	81/855 (9.5%)	778/855 (91.0%)
Cross-treated Participants	0/1 (0.0%)	1/1 (100.0%)	1/1 (100.0%)

Serious adverse events by term

Term	Organ system	V114	Prevnar 13™	Cross-treated Participants
Iron deficiency anaemia	Blood and lymphatic system disorders	1/858	0/855	0/1
Heart disease congenital	Congenital, familial and genetic disorders	1/858	0/855	0/1
Diarrhoea	Gastrointestinal disorders	2/858	1/855	0/1
Enteritis	Gastrointestinal disorders	0/858	1/855	0/1
Flatulence	Gastrointestinal disorders	0/858	1/855	0/1
Gastritis	Gastrointestinal disorders	1/858	1/855	0/1
Gastrooesophageal reflux disease	Gastrointestinal disorders	0/858	1/855	0/1
Haematochezia	Gastrointestinal disorders	1/858	0/855	0/1
Inguinal hernia	Gastrointestinal disorders	1/858	0/855	0/1
Pyrexia	General disorders	2/858	3/855	0/1
Anaphylactic reaction	Immune system disorders	2/858	0/855	0/1
Abscess limb	Infections and infestations	1/858	1/855	0/1
Bacteraemia	Infections and infestations	2/858	1/855	0/1
Bronchiolitis	Infections and infestations	11/858	6/855	1/1
Bronchitis	Infections and infestations	5/858	2/855	0/1
Bronchitis viral	Infections and infestations	1/858	0/855	0/1
COVID-19	Infections and infestations	2/858	1/855	0/1
Croup infectious	Infections and infestations	2/858	1/855	0/1
Cystitis	Infections and infestations	1/858	0/855	0/1
Dengue fever	Infections and infestations	1/858	1/855	0/1
Diarrhoea infectious	Infections and infestations	1/858	1/855	0/1
Enterovirus infection	Infections and infestations	1/858	0/855	0/1
Escherichia urinary tract infection	Infections and infestations	1/858	1/855	0/1
Exanthema subitum	Infections and infestations	3/858	3/855	0/1
Gastroenteritis	Infections and infestations	7/858	11/855	0/1
Gastroenteritis bacterial	Infections and infestations	0/858	1/855	0/1
Gastroenteritis viral	Infections and infestations	6/858	2/855	0/1
Hand-foot-and-mouth disease	Infections and infestations	0/858	1/855	0/1
Herpangina	Infections and infestations	1/858	0/855	0/1
Influenza	Infections and infestations	2/858	1/855	0/1
Nasopharyngitis	Infections and infestations	1/858	1/855	0/1
Oral herpes	Infections and infestations	0/858	1/855	0/1
Oral viral infection	Infections and infestations	0/858	1/855	0/1
Otitis media	Infections and infestations	1/858	0/855	0/1
Periorbital cellulitis	Infections and infestations	1/858	0/855	0/1
Pharyngitis	Infections and infestations	2/858	0/855	0/1
Pneumonia	Infections and infestations	5/858	5/855	0/1
Pneumonia influenzal	Infections and infestations	0/858	1/855	0/1
Pneumonia respiratory syncytial viral	Infections and infestations	4/858	1/855	0/1
Pneumonia viral	Infections and infestations	1/858	2/855	0/1
Pyelonephritis acute	Infections and infestations	0/858	1/855	0/1
Respiratory syncytial virus bronchiolitis	Infections and infestations	7/858	12/855	0/1
Respiratory syncytial virus infection	Infections and infestations	1/858	3/855	0/1
Scarlet fever	Infections and infestations	0/858	1/855	0/1
Sepsis	Infections and infestations	1/858	1/855	0/1
Septic shock	Infections and infestations	0/858	1/855	0/1
Upper respiratory tract infection	Infections and infestations	2/858	2/855	0/1
Urinary tract infection	Infections and infestations	3/858	3/855	0/1
Varicella	Infections and infestations	0/858	1/855	0/1
Viral diarrhoea	Infections and infestations	0/858	1/855	0/1
Viral infection	Infections and infestations	4/858	2/855	0/1
Viral rash	Infections and infestations	2/858	2/855	0/1
Viral rhinitis	Infections and infestations	0/858	1/855	0/1
Viral upper respiratory tract infection	Infections and infestations	2/858	1/855	0/1
Brain contusion	Injury, poisoning and procedural complications	1/858	0/855	0/1
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	1/858	0/855	0/1
Head injury	Injury, poisoning and procedural complications	0/858	2/855	0/1
Road traffic accident	Injury, poisoning and procedural complications	0/858	1/855	0/1
Failure to thrive	Metabolism and nutrition disorders	1/858	0/855	0/1
Altered state of consciousness	Nervous system disorders	0/858	1/855	0/1

9 more terms not shown.

Other adverse events by term

Term	Organ system	V114	Prevnar 13™	Cross-treated Participants
Diarrhoea	Gastrointestinal disorders	46/858	62/855	0/1
Vomiting	Gastrointestinal disorders	42/858	46/855	0/1
Injection site erythema	General disorders	289/858	329/855	1/1
Injection site induration	General disorders	226/858	229/855	1/1
Injection site pain	General disorders	427/858	401/855	1/1
Injection site swelling	General disorders	226/858	205/855	0/1
Pyrexia	General disorders	265/858	270/855	0/1
Upper respiratory tract infection	Infections and infestations	55/858	42/855	0/1
Decreased appetite	Metabolism and nutrition disorders	294/858	308/855	0/1
Somnolence	Nervous system disorders	506/858	530/855	0/1
Irritability	Psychiatric disorders	656/858	645/855	1/1
Cough	Respiratory, thoracic and mediastinal disorders	35/858	45/855	0/1
Nasal congestion	Respiratory, thoracic and mediastinal disorders	36/858	47/855	0/1
Urticaria	Skin and subcutaneous tissue disorders	56/858	56/855	0/1

+Locations (81)

Facility	City	Country
Alabama Clinical Therapeutics ( Site 0159)	Birmingham, Alabama	United States
Southeastern Pediatric Associates, P.A. ( Site 0107)	Dothan, Alabama	United States
South Alabama Pediatrics ( Site 0263)	Opp, Alabama	United States
Northwest Arkansas Pediatric Clinic ( Site 0172)	Fayetteville, Arkansas	United States
Children's Clinic of Jonesboro, PA ( Site 0184)	Jonesboro, Arkansas	United States
Advanced Clinical Research - Rancho Paseo ( Site 0163)	Banning, California	United States
Altissima Clinical Research LLC ( Site 0213)	Bellflower, California	United States
Southland Clinical Research Center ( Site 0187)	Bellflower, California	United States
Premier Health Research Center, LLC ( Site 0121)	Downey, California	United States
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)	Oakland, California	United States
Kaiser Permanente - Sacramento ( Site 0257)	Sacramento, California	United States
Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256)	Sacramento, California	United States
Kaiser Permanente - San Jose ( Site 0258)	San Jose, California	United States
Kaiser Permanente - Santa Clara ( Site 0244)	Santa Clara, California	United States
Davita Medical Group ( Site 0141)	Colorado Springs, Colorado	United States
Suncoast Research Associates, LLC ( Site 0250)	Miami, Florida	United States
Suncoast Research Associates, LLC ( Site 0249)	North Miami Beach, Florida	United States
Children's Health Center ( Site 0272)	Tampa, Florida	United States
Saltzer Medical Group ( Site 0215)	Nampa, Idaho	United States
Kentucky Pediatric/Adult Research Inc ( Site 0136)	Bardstown, Kentucky	United States
Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276)	Nicholasville, Kentucky	United States
ACC Pediatric Research ( Site 0147)	Haughton, Louisiana	United States
Medpharmics, LLC ( Site 0157)	Metairie, Louisiana	United States
Virgo-Carter Pediatrics ( Site 0275)	Silver Spring, Maryland	United States
Tufts Medical Center-Floating Hospital for Children ( Site 0129)	Boston, Massachusetts	United States
Pediatric Associates of Fall River ( Site 0183)	Fall River, Massachusetts	United States
MediSync Clinical Research Hattiesburg Clinic ( Site 0259)	Petal, Mississippi	United States
Children's Mercy Clinics on Broadway ( Site 0171)	Kansas City, Missouri	United States
Midwest Children's Health Research Institute, LLC ( Site 0109)	Lincoln, Nebraska	United States
Midwest Children's Health Research Institute, LLC ( Site 0106)	Lincoln, Nebraska	United States
Children's Physicians, UNMC ( Site 0252)	Omaha, Nebraska	United States
Southwest CARE Center ( Site 0161)	Santa Fe, New Mexico	United States
Child Health Care Associates ( Site 0242)	East Syracuse, New York	United States
Child Health Care Associates ( Site 0267)	Liverpool, New York	United States
Advantage Clinical Trials ( Site 0274)	The Bronx, New York	United States
Haywood Pediatric and Adolescent Medicine Group ( Site 0248)	Clyde, North Carolina	United States
Capitol Pediatrics & Adolescent Center ( Site 0223)	Raleigh, North Carolina	United States
Senders Pediatrics ( Site 0190)	Cleveland, Ohio	United States
Dayton Clinical Research ( Site 0188)	Dayton, Ohio	United States
Cyn3rgy Research ( Site 0246)	Gresham, Oregon	United States
Pediatric Medical Associates ( Site 0239)	East Norriton, Pennsylvania	United States
Allegheny Health & Wellness Pavilion West ( Site 0210)	Erie, Pennsylvania	United States
Lockman & Lubell Pediatrics ( Site 0166)	Fort Washington, Pennsylvania	United States
CCP- Kid's Way ( Site 0130)	Hermitage, Pennsylvania	United States
Palmetto Pediatrics, PA ( Site 0164)	Charleston, South Carolina	United States
Cheraw Pediatrics ( Site 0280)	Cheraw, South Carolina	United States
Parkside Pediatric ( Site 0125)	Greenville, South Carolina	United States
Holston Medical Group ( Site 0165)	Kingsport, Tennessee	United States
DFW Clinical Research ( Site 0111)	Dallas, Texas	United States
University of Texas Medical Branch ( Site 0185)	Galveston, Texas	United States
Ventavia Research Group LLC ( Site 0142)	Houston, Texas	United States
Pediatric Associates ( Site 0209)	Houston, Texas	United States
Houston Clinical Research Network ( Site 0266)	Houston, Texas	United States
Ventavia Research Group LLC ( Site 0139)	Keller, Texas	United States
FMC Science ( Site 0115)	Lampasas, Texas	United States
University of Texas Medical Branch ( Site 0170)	League City, Texas	United States
DCOL Center for Clinical Research ( Site 0247)	Longview, Texas	United States
Wee Care Pediatrics ( Site 0154)	Layton, Utah	United States
Cottonwood Pediatrics ( Site 0153)	Murray, Utah	United States
Pediatric Care ( Site 0138)	Provo, Utah	United States
Wee Care Pediatrics-Roy ( Site 0174)	Roy, Utah	United States
University of Utah ( Site 0214)	Salt Lake City, Utah	United States
Dixie Pediatrics ( Site 0260)	St. George, Utah	United States
Wee Care Pediatrics ( Site 0193)	Syracuse, Utah	United States
MultiCare Rockwood Cheney Clinic ( Site 0195)	Cheney, Washington	United States
Multicare / Rockwood Clinic ( Site 0167)	Spokane, Washington	United States
Cooperativa de Facultad Medica Sanacoop ( Site 0077)	Bayamón	Puerto Rico
Clinical Research of Puerto Rico ( Site 0075)	Guayama	Puerto Rico
CAIMED Center - Ponce School of Medicine ( Site 0076)	Ponce	Puerto Rico
San Juan Hospital ( Site 0079)	San Juan	Puerto Rico
University of Puerto Rico - Medical Science Campus ( Site 0078)	San Juan	Puerto Rico
Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081)	Trujillo Alto	Puerto Rico
Khon Kaen University ( Site 0031)	Muang, Changwat Khon Kaen	Thailand
Phramongkutklao Hospital ( Site 0033)	Bangkok	Thailand
Siriraj Hospital ( Site 0032)	Bangkok	Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0030)	Chiang Mai	Thailand
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060)	Adana	Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi ( Site 0053)	Ankara	Turkey (Türkiye)
Ege University Medical Faculty Hospital ( Site 0050)	Izmir	Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine ( Site 0054)	Izmir	Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi ( Site 0057)	Kayseri	Turkey (Türkiye)

+Publications

Results publication: Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016/j.vaccine.2022.12.054. Epub 2023 Jan 6. PMID 36621410
Results publication: Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19. PMID 37846456

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2021-03-16)

+Investigators

Medical Director, Study director, Merck Sharp & Dohme LLC

+Funding

NIH grants: 2018