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Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: PCV13
Biological: V114

Study type

Interventional

Funder types

Industry

Identifiers

NCT04384107
2019-003644-68 (Other Identifier)
V114-033 (Other Identifier)
205287 (Registry Identifier)

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.

Enrollment

694 patients

Sex

All

Ages

2 to 6 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Japanese male or female

Exclusion criteria

  • Has a history of invasive pneumococcal disease (IPD)
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
  • Has a known or suspected impairment of immunological function
  • Has a history of congenital or acquired immunodeficiency
  • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
  • Has or his/her mother has a documented hepatitis B surface antigen-positive test
  • Has known or history of functional or anatomic asplenia
  • Has a history of autoimmune disease
  • Has a known neurologic or cognitive behavioral disorder
  • Has received a dose of any pneumococcal vaccine prior to study entry
  • Has received a blood transfusion or blood products, including immunoglobulins

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

694 participants in 2 patient groups

V114
Experimental group
Description:
Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Treatment:
Biological: V114
Pneumococcal 13-valent Conjugate Vaccine (PCV13)
Active Comparator group
Description:
Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
Treatment:
Biological: PCV13

Trial documents
2

Trial contacts and locations

45

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Data sourced from clinicaltrials.gov

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