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Clinical trial

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants

ID
Name
V114-033
Description
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.
Trial arms
Trial start
2020-07-01
Estimated PCD
2021-12-01
Trial end
2021-12-01
Status
Completed
Phase
Early phase I
Treatment
V114
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.
Arms:
V114
Other names:
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
PCV13
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.
Arms:
Pneumococcal 13-valent Conjugate Vaccine (PCV13)
Other names:
Prevnar 13™
Size
694
Primary endpoint
Percentage of Participants With Solicited Injection-Site Adverse Events
Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Percentage of Participants With Solicited Systemic Adverse Events
Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Percentage of Participants With Vaccine-Related Serious Adverse Events
~1 month after Dose 4, up to a total of 14 months
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
30 Days after Dose 3, up to a total of 11 months
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
30 Days after Dose 3, up to a total of 11 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 694, 'type': 'ACTUAL'}}
Updated at
2023-07-28

1 organization

2 products

1 indication

Product
V114
Indication
Pneumococcal Infections
Product
PCV13
Organization
Merck Sharp & Dohme