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

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

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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