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Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)

NCT04016714 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1191

Last updated 2023-05-06

Study results available
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Summary

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.

The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.

Conditions

  • Pneumococcal Infections

Interventions

DRUG

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.

DRUG

Prevenar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.

DRUG

Vaxelis™

Intramuscular 0.5 mL single dose

DRUG

M-M-R®II

Subcutaneous 0.5 mL single dose

DRUG

VARIVAX™

Subcutaneous 0.5 mL single dose

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Days
Max Age
111 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2021-10-29
Completion
2021-10-29
FDA Drug
Yes

Countries

  • Denmark
  • Finland
  • Italy
  • Norway
  • Sweden

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 NCT04016714 on ClinicalTrials.gov