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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.