A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506236-32-00

Acronym

V116-013

Enrollment

215

Registered

2024-03-18

Start date

2024-03-25

Completion date

2025-02-25

Last updated

2025-02-25

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 adverse events (AEs), Percentage of participants with solicited systemic AEs, Percentage of participants with vaccine-related serious adverse events (SAEs), Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) following vaccination

Detailed description

Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination, Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs, Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs, GMFR from baseline in serotype-specific IgG GMCs, Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs

Interventions

DRUGPneumovax® 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine

DRUGV110

DRUGPneumococcal 21-valent Conjugate Vaccine

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percentage of participants with solicited injection-site adverse events (AEs), Percentage of participants with solicited systemic AEs, Percentage of participants with vaccine-related serious adverse events (SAEs), Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) following vaccination	—

Secondary

Measure	Time frame
Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination, Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs, Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs, GMFR from baseline in serotype-specific IgG GMCs, Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs	—

Measure

Time frame

—

Countries

Finland, France, Poland, Spain, Sweden

Outcome results

None listed

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