NCT04016714

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

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,191 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 70 Days – 111 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-08-28
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2019-07-11
• Last updated: 2023-05-06
• Results posted: 2022-12-01

Locations

24 sites across 5 countries: Denmark, Finland, Italy, Norway, Sweden

Regulatory

• FDA-regulated drug study