A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pneumococcal Infection
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Percentage of Participants With a Solicited Systemic AE
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.
Investigators
Eligibility Criteria
Inclusion Criteria
- •is a healthy Japanese male or female ≥20 years of age at time of randomization
- •male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
- •female participants must not be pregnant or breastfeeding, and is either:
- •not a woman of childbearing potential (WOCBP) or
- •a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
Exclusion Criteria
- •has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
- •has a known hypersensitivity to any vaccine components
- •has impaired immunological function
- •has a coagulation disorder
- •had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
- •has a known malignancy that is progressing/requiring treatment
- •has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
- •has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
- •is receiving immunosuppressive therapy
- •has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
Outcomes
Primary Outcomes
Percentage of Participants With a Solicited Systemic AE
Time Frame: Up to 5 days postvaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Time Frame: Up to 5 days postvaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
Time Frame: Up to 62 days postvaccination
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.
Secondary Outcomes
- Serotype-specific OPA GMTs for the Unique Serotypes in V116(Day 30 postvaccination)
- Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA(Baseline (Day 1) and Day 30 postvaccination)
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23(Day 30 postvaccination)
- GMFR From Baseline in Serotype-specific IgG GMCs(Baseline (Day 1) and Day 30 postvaccination)
- Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23(Day 30 postvaccination)
- Serotype-specific IgG GMCs for the Unique Serotypes in V116(Day 30 postvaccination)