MedTrace Logo

Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)

NCT03885934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2023-01-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

V114

V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

BIOLOGICAL

Prevnar 13®

Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-12-09
Completion
2020-12-09
FDA Drug
Yes

Countries

  • Finland
  • Malaysia
  • Poland
  • Russia
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885934 on ClinicalTrials.gov