Phase 3
N=1,080
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
Pneumonia, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT05526716 ↗Enrolled (actual)
1,080
Serious AEs
2.5%
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Solicited Injection-site Adverse Events (AEs) — 317; 314 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V116 (Biological); QIV (Biological); Matching Placebo for V116 (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Injection-site Adverse Events (AEs) |
317; 314 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs |
219; 224 | — |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) |
0; 1 | — |
| PRIMARY Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses |
209.2; 250.1; 2056.4; 2608.2; 2399.2; 3275.4 | — |
| PRIMARY GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) |
268.23; 325.06; 128.07; 163.06; 70.02; 85.66 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) |
0.60; 0.66; 3.34; 3.58; 3.91; 5.01 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA |
5.2; 6.7; 9.4; 13.2; 8.1; 9.8 | — |
| SECONDARY GMFR Ratio of Serotype-specific IgG |
3.6; 4.1; 7.8; 8.4; 5.6; 7.2 | — |
| SECONDARY GMFR in Influenza Strain-specific HAI |
4.5; 5.7; 5.6; 7.1; 3.6; 4.5 | — |
| SECONDARY Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40 |
47.1; 55.6; 63.8; 68.3; 52.3; 54.1 | — |
Summary
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
Eligibility Criteria
Inclusion Criteria
- Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
- Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
Exclusion Criteria
- History of IPD or other culture-positive pneumococcal disease
- Known or suspected impairment of immunological function
- Receipt of systemic corticosteroids or immunosuppressive therapy
- Received any pneumococcal vaccine <12 months prior to enrollment
- Prior administration of PCV15 or PCV20
- Received any influenza vaccine <6 months prior to enrollment
Data sourced from ClinicalTrials.gov (NCT05526716). 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.