A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

Phase 3

Completed

• Conditions: Pneumococcal Infection
• Interventions: Biological: V116; Biological: PPSV23

• Registration Number: NCT06177912
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. 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 invasive pneumococcal disease (IPD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-20
• Study Start: 2024-01-18
• Primary Completion: 2025-02-26
• Study Completion: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 882

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

• Has previously received PPSV23 vaccine
• Has a history of active hepatitis within 3 months before study vaccination
• History of invasive pneumococcal disease within 3 years before study vaccination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V116	V116	Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1
PPSV23	PPSV23	Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with vaccine-related serious adverse events (SAEs)	Up to approximately 6 months	A vaccine-related SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
Percentage of participants with solicited injection-site adverse events (AEs)	Up to 5 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include pain/tenderness, redness/erythema, and swelling.
Percentage of participants with solicited systemic AEs	Up to 5 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs include headache, muscle aches/myalgia, and tiredness/fatigue.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses	30 days postvaccination	Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA)

Secondary Outcome Measures

Name	Time	Method
Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs	Baseline (Day 1) and Day 30 postvaccination	The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.
Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs	Baseline (Day 1) and Day 30 postvaccination	The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA.
GMFR from baseline in serotype-specific IgG GMCs	Baseline (Day 1) and Day 30 postvaccination	The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.
Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs	Baseline (Day 1) and Day 30 postvaccination	The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL.
Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination	30 days postvaccination	The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL)

Trial Locations

Locations (92)

Premier Clinical Trial Network ( Site 0008); 🇨🇦 Hamilton, Ontario, Canada

Central Research Associates ( Site 0145); 🇺🇸 Birmingham, Alabama, United States

Velocity Clinical Research, Phoenix ( Site 0122); 🇺🇸 Phoenix, Arizona, United States

Madera Family Medical Group ( Site 0120); 🇺🇸 Madera, California, United States

Optumcare Colorado Springs, LLC ( Site 0113); 🇺🇸 Colorado Springs, Colorado, United States

Accel Research Sites Network- Nona Pediatric Center ( Site 0109); 🇺🇸 Orlando, Florida, United States

University of South Florida-Department of Pediatrics ( Site 0110); 🇺🇸 Tampa, Florida, United States

Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128); 🇺🇸 Macon, Georgia, United States

Bingham Memorial Hospital ( Site 0149); 🇺🇸 Blackfoot, Idaho, United States

Clinical Research Prime ( Site 0105); 🇺🇸 Idaho Falls, Idaho, United States

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