Phase 1
Completed N=102
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
Pneumococcal Infection
Source: ClinicalTrials.gov NCT04665050 ↗
Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) — 9.8; 9.8; 54.9; 66.7 Percentage of Participants
Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event (AE) |
9.8; 9.8; 54.9; 66.7; 13.7; 13.7 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic AE |
13.7; 9.8; 3.9; 3.9; 17.6; 19.6 | — |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) |
0.0; 0.0 | — |
| SECONDARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 |
161.08; 100.76; 5327.67; 4406.11; 1479.82; 738.52 | — |
| SECONDARY Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 |
1.13; 0.73; 10.29; 4.66; 10.75; 4.97 | — |
| SECONDARY Serotype-specific OPA GMTs for the Unique Serotypes in V116 |
1663.20; 464.65; 5030.66; 807.16; 3641.84; 1565.56 | — |
| SECONDARY Serotype-specific IgG GMCs for the Unique Serotypes in V116 |
6.38; 2.13; 16.39; 2.04; 21.42; 6.81 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA |
9.86; 6.35; 19.79; 21.53; 10.80; 6.74 | — |
| SECONDARY GMFR From Baseline in Serotype-specific IgG GMCs |
5.92; 4.47; 23.86; 10.51; 7.58; 3.52 | — |
Eligibility Criteria
Inclusion Criteria
- is a healthy Japanese male or female ≥20 years of age at time of randomization
- male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
- female participants must not be pregnant or breastfeeding, and is either:
- not a woman of childbearing potential (WOCBP) or
- a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
Exclusion Criteria
- has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
- has a known hypersensitivity to any vaccine components
- has impaired immunological function
- has a coagulation disorder
- had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
- has a known malignancy that is progressing/requiring treatment
- has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
- has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
- is receiving immunosuppressive therapy
- has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
- has received any live vaccine from 30 days prior to Day 1
- has received a blood transfusion or blood products
- has participated in another clinical trial within 2 months of this study
- has clinically relevant drug or alcohol abuse
- has any condition that, in the opinion of the investigator, precludes participation in this study
Data sourced from ClinicalTrials.gov (NCT04665050). 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.