Safety and Immunogenicity Study of 20vPnC in Adults 18 Years and above of Age in India
- Registration Number
- CTRI/2023/06/053599
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Generally healthy participants 18 years and above of age at the time of consent.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid containing vaccine.
- Known or suspected immune deficiency or suppression.
-Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study.
-Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Percentage of participants reporting prompted local reactions within 7 days after vaccination <br/ ><br>2.Percentage of participants reporting prompted systemic events within 7 days after vaccination. <br/ ><br>3.Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination <br/ ><br>4.Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after vaccination <br/ ><br>Timepoint: 1. 7 days <br/ ><br>2. 7 days <br/ ><br>3. 1 month <br/ ><br>4. 1 month <br/ ><br>
- Secondary Outcome Measures
Name Time Method Pneumococcal opsonophagocytic activity (OPA) geometric mean fold rise (GMFR)Timepoint: 1 month