Phase 3
Completed N=694
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT04384107 ↗
Enrolled (actual)
694
Serious AEs
6.8%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Participants With Solicited Injection-Site Adverse Events — 88.2; 89.3; 81.0; 81.2 Percentage of Participants — p== 0.641
◆ Published Evidence
Emerging
3citations · ~1 / year
Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033).
Summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
Linked Publications
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Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-Site Adverse Events |
88.2; 89.3; 81.0; 81.2; 31.1; 24.0 | = 0.641 |
| PRIMARY Percentage of Participants With Solicited Systemic Adverse Events |
23.9; 24.3; 66.6; 60.7; 55.9; 54.9 | = 0.912 |
| PRIMARY Percentage of Participants With Vaccine-Related Serious Adverse Events |
0.3; 0.3 | — |
| PRIMARY Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 |
99.7; 100.0; 100.0; 97.7; 100.0; 100.0 | < 0.001 sig |
| PRIMARY Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 |
2.39; 3.95; 2.63; 1.42; 2.98; 3.54 | < 0.001 sig |
| SECONDARY GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 |
6.59; 0.06; 1.85; 0.06 | — |
| SECONDARY Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 |
99.7; 100.0; 100.0; 96.7; 99.7; 100.0 | — |
| SECONDARY GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 |
2.74; 5.19; 2.18; 1.28; 2.91; 3.18 | — |
| SECONDARY Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 |
211.51; 322.44; 660.68; 471.43; 3984.87; 4118.16 | — |
| SECONDARY GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 |
453.42; 854.50; 1444.00; 893.97; 4531.52; 6264.94 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese male or female
Exclusion Criteria
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
- Has a known or suspected impairment of immunological function
- Has a history of congenital or acquired immunodeficiency
- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- Has or his/her mother has a documented hepatitis B surface antigen-positive test
- Has known or history of functional or anatomic asplenia
- Has a history of autoimmune disease
- Has a known neurologic or cognitive behavioral disorder
- Has received a dose of any pneumococcal vaccine prior to study entry
- Has received a blood transfusion or blood products, including immunoglobulins
Data sourced from ClinicalTrials.gov (NCT04384107) 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.