Phase 3
N=882
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
Pneumococcal Infection
Bottom Line
View on ClinicalTrials.gov: NCT06177912 ↗Enrolled (actual)
882
Serious AEs
6.2%
Results posted
Mar 2026
Primary outcome: Primary: Percentage of Participants With Solicited Injection-site Adverse Events (AEs) — 24.3; 16.4; 67.7; 54.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V116 (Biological); PPSV23 (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-site Adverse Events (AEs) |
24.3; 16.4; 67.7; 54.5; 18.8; 18.2 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs |
4.4; 5.5; 20.1; 21.0; 17.1; 15.3 | — |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) |
0.2; 0.6 | — |
| PRIMARY Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses |
526.6; 517.0; 20618.1; 14207.2; 12294.5; 8966.9 | < 0.001 sig |
| SECONDARY Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination |
1.56; 1.88; 7.33; 7.37; 13.68; 17.86 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs |
7.9; 7.6; 15.8; 10.5; 30.5; 21.7 | — |
| SECONDARY Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs |
64.6; 66.1; 84.2; 79.7; 92.3; 90.6 | — |
| SECONDARY GMFR From Baseline in Serotype-specific IgG GMCs |
5.8; 6.6; 23.0; 23.3; 34.5; 40.5 | — |
| SECONDARY Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs |
59.3; 62.2; 92.5; 97.4; 94.4; 94.8 | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting pneumococcal disease (PD).
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.
- Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.
Exclusion Criteria
- Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
- Has a history of active hepatitis within 3 months before study vaccination.
- Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination.
- Has a history of severely decreased kidney function dialysis, autoimmune related chronic kidney disease, nephrotic syndrome of any cause, or an acute/reversible cause of kidney disease.
- Has a history of severe pulmonary hypertension or history of Eisenmenger syndrome.
- History of invasive pneumococcal disease within 3 years before study vaccination.
Data sourced from ClinicalTrials.gov (NCT06177912). 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.