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

Purpose

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 superior to Prevnar 13™ for the 2 serotypes unique to V114 based on response rates at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is superior to Prevnar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs 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 superior to Prevnar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4.

Conditions

  • Pneumococcal Infections
  • Pneumococcal Vaccines

Eligibility

Eligible Ages
Between 42 Days and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria

  • Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
  • Has any contraindication to the concomitant study vaccines being administered in the study.
  • Had a recent febrile illness (rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
V114
Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
  • 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: 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: M-M-R™
    One M-M-R™ 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.
Active Comparator
Prevnar 13™
Participants receive 4 total 0.5 mL IM vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
  • 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: M-M-R™
    One M-M-R™ 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.

Recruiting Locations

University of Texas Medical Branch ( Site 0185)
Galveston, Texas 77555
Contact:
Study Coordinator
409-772-5278

University of Texas Medical Branch ( Site 0170)
League City, Texas 77573
Contact:
Study Coordinator
832-340-2310

More Details

NCT ID
NCT03893448
Status
Recruiting
Sponsor
Merck Sharp & Dohme Corp.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com