NCT03893448

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,720 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 42 Days – 90 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Conditions

• Pneumococcal Infections
• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	V114	V114 15-valent pneumococcal conjugate vaccine 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 intramuscular administration.
BIOLOGICAL	Prevnar 13™	Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
BIOLOGICAL	RotaTeq™	A total of 3 RotaTeq™ 2 mL oral dosings at \~2, \~4, and \~6 months of age.
BIOLOGICAL	Pentacel™	A total of 3 Pentacel™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
BIOLOGICAL	RECOMBIVAX HB™	A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.
BIOLOGICAL	VAQTA™	One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
BIOLOGICAL	MMR II™	One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
BIOLOGICAL	VARIVAX™	One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
BIOLOGICAL	HIBERIX™	One HIBERIX™ 0.5 mL IM dosing at Visit 5.

Timeline

• Start date: 2019-06-19
• Primary completion: 2021-05-24
• Completion: 2021-05-24
• First posted: 2019-03-28
• Last updated: 2023-07-28
• Results posted: 2022-03-25

Locations

81 sites across 4 countries: United States, Puerto Rico, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study