Phase 2
Completed N=1,051
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT02987972 ↗
Enrolled (actual)
1,051
Serious AEs
5.0%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 — 96.8; 97.8; 96.9; 96.0 Percentage of Participants — p=< 0.001
Summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to =0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 |
96.8; 97.8; 96.9; 96.0; 94.1; 71.8 | < 0.001 sig |
| PRIMARY Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 |
1.19; 1.37; 1.65; 1.04; 1.02; 0.53 | — |
| PRIMARY Percentage of Participants Who Experience at Least 1 Adverse Event |
95.7; 97.7; 95.7 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Due to an Adverse Event |
0.3; 0.3; 0.0 | — |
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event |
76.6; 76.7; 70.3 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic Adverse Event |
90.3; 92.2; 89.6 | 0.772 |
| SECONDARY Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 |
0.32; 0.35; 0.46; 0.25; 0.26; 0.12 | — |
| SECONDARY Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 |
1.75; 2.00; 2.47; 1.12; 1.16; 0.78 | — |
Eligibility Criteria
Inclusion Criteria
- Infant approximately 2 months of age (42 days to 90 days), inclusive
- In good health
Exclusion Criteria
- Prior administration of any pneumococcal vaccine
- Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency (eg, splenomegaly)
- Mother has documented human immunodeficiency virus (HIV) infection
- Mother has documented hepatitis B surface antigen-positive test result
- Known or history of functional or anatomic asplenia
- History of failure to thrive
- History of a coagulation disorder
- History of autoimmune disease
- Known neurologic or cognitive behavioral disorder
- Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
- Prior administration of a blood transfusion or blood products, including immunoglobulin
- Participated in another clinical trial of an investigational product
- History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Data sourced from ClinicalTrials.gov (NCT02987972). 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.