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

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

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

42 Days

Max Age

90 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-19

Primary Completion

2021-05-24

Completion

2021-05-24

FDA Drug

Yes

Countries

• United States
• Puerto Rico
• Thailand
• Turkey (Türkiye)

Study Locations