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A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503144-40-00
Acronym
V116-010-00
Enrollment
300
Registered
2023-06-21
Start date
2022-11-17
Completion date
2025-01-30
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal disease

Brief summary

Percentage of participants with solicited injection-site AEs, Percentage of participants with solicited systemic AEs, Percentage of participants with vaccine-related serious AE (SAE), Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs), Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs (unique to V116)

Detailed description

Percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs, Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs), Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs, Serotype-specific GMFR in IgG GMCs, Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes), Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs

Interventions

DRUGPneumococcal 21-valent Conjugate Vaccine
DRUGPNEUMOCOCCUS
DRUGPURIFIED POLYSACCHARIDES ANTIGEN

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants with solicited injection-site AEs, Percentage of participants with solicited systemic AEs, Percentage of participants with vaccine-related serious AE (SAE), Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs), Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs (unique to V116)—

Secondary

MeasureTime frame
Percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs, Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs), Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs, Serotype-specific GMFR in IgG GMCs, Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes), Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026