Phase 3
Completed N=1,720
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Pneumococcal Infections · Pneumococcal Vaccines
Source: ClinicalTrials.gov NCT03893448 ↗
Enrolled (actual)
1,720
Serious AEs
9.9%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ — 69.0; 69.2; 33.7; 38.5 Percentage of participants — p== 0.039
◆ Published Evidence
Established
42citations · ~14 / year
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).
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.
Linked Publications (2)
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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).
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ |
69.0; 69.2; 33.7; 38.5; 26.3; 26.8 | = 0.039 sig |
| PRIMARY Percentage of Participants With Solicited Systemic AEs |
84.4; 84.8; 34.3; 36.0; 76.5; 75.4 | = 0.446 |
| PRIMARY Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 |
95.7; 99.1; 94.7; 79.2; 96.4; 98.6 | < 0.001 sig |
| PRIMARY Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 |
1.21; 1.89; 1.08; 0.62; 1.29; 1.35 | < 0.001 sig |
| PRIMARY GMC of Anti-PnP IgG Ab One Month After Vaccination 4 |
1.35; 2.03; 0.96; 0.71; 1.23; 1.60 | < 0.001 sig |
| SECONDARY 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 |
96.9; 97.6; 100.0; 99.8; 99.0; 98.5 | < 0.001 sig |
| SECONDARY Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 |
43.73; 44.35; 67.51; 69.18; 39.79; 36.87 | < 0.001 sig |
| SECONDARY Hepatitis A Antibody Response Rate One Month After Vaccination 4 |
97.4; 97.1 | < 0.001 sig |
| SECONDARY Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 |
98.1; 98.3; 95.8; 97.5; 98.1; 98.9 | < 0.001 sig |
| SECONDARY Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 |
96.4; 97.7 | < 0.001 sig |
| SECONDARY Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 |
98.9; 100.0 | < 0.001 sig |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes |
4.91; 0.05; 1.67; 0.06 | < 0.001 sig |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes |
98.6; 3.5; 87.3; 2.1 | < 0.001 sig |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes |
7.52; 0.11; 4.15; 0.09 | < 0.001 sig |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 |
56.9; 78.3; 284.7; 210.6; 1304.8; 1566.7 | — |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 |
86.5; 87.7; 100.0; 100.0; 99.4; 100.0 | — |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 |
94.7; 79.2 | < 0.001 sig |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 |
1.08; 0.62 | < 0.001 sig |
| SECONDARY Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 |
0.96; 0.71 | < 0.001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03893448) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.