A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwa
- Registration Number
- CTRI/2024/04/065558
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female infants born at =36 weeks of gestation and approximately 42 to 84 days of age at the time of consent
2. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
3. Weight of 3.0 kg or greater at the time of randomization
1. History of severe adverse reaction associated with a vaccine and or severe allergic reaction eg. anaphylaxis to any component of 13vPnC, 20vPnC or any other diphtheria toxoid containing vaccine
2. Major known congenital malformation or serious chronic disorder
3. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method