A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Phase 1
Completed
- Conditions
- Pneumococcal Infection
- Interventions
- Biological: 13-valent Pneumococcal Conjugate Vaccine
- Registration Number
- NCT01531322
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
-
Age at the time of enrollment is:
- 18 through 55 years (before the fifty sixth birthday) for Group 1.
- 3 through 5 years (before the sixth birthday) for Group 2.
- 42 to 98 days for Group 3.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 2 13-valent Pneumococcal Conjugate Vaccine Children aged 3 through 5 years (before the sixth birthday) Group 3 13-valent Pneumococcal Conjugate Vaccine Infants aged approximately 2 months (42 to 98 days) Group 1 13-valent Pneumococcal Conjugate Vaccine Adults aged 18 through 55 years (before the fifty sixth birthday)
- Primary Outcome Measures
Name Time Method Number of participants reporting Adverse Events Baseline to Month 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Nanjing, Jiangsu, China