A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Number of participants reporting Adverse Events
Study Overview
Brief Summary
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 42 Days to 55 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age at the time of enrollment is:
- •18 through 55 years (before the fifty sixth birthday) for Group
- •3 through 5 years (before the sixth birthday) for Group
- •42 to 98 days for Group
- •Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
- •Previous vaccination with licensed or investigational pneumococcal vaccine.
- •Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with pneumococcal vaccine.
Arms & Interventions
Group 1
Adults aged 18 through 55 years (before the fifty sixth birthday)
Intervention: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 3
Infants aged approximately 2 months (42 to 98 days)
Intervention: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Group 2
Children aged 3 through 5 years (before the sixth birthday)
Intervention: 13-valent Pneumococcal Conjugate Vaccine (Biological)
Outcomes
Primary Outcomes
Number of participants reporting Adverse Events
Time Frame: Baseline to Month 1
Secondary Outcomes
No secondary outcomes reported