A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
- Conditions
- Pneumococcal Disease
- Registration Number
- NCT05512819
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 401
Inclusion Criteria:<br><br> - Male or female infants born at =36 weeks of gestation and approximately 2 months of<br> age at the time of consent<br><br> - Healthy infants determined by clinical assessment, including medical history and<br> clinical judgment, to be eligible for the study<br><br> - Weight of 3.0 kg or greater at the time of randomization<br><br>Exclusion Criteria:<br><br> - History of severe adverse reaction associated with a vaccine and/or severe allergic<br> reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other<br> diphtheria toxoid-containing vaccine.<br><br> - Major known congenital malformation or serious chronic disorder<br><br> - Other acute or chronic medical or psychiatric condition or laboratory abnormality<br> that may increase the risk associated with study participation or study intervention<br> administration or may interfere with the interpretation of study results and, in the<br> judgment of the investigator, would make the participant inappropriate for entry<br> into this study<br><br> - Previous vaccination with any licensed or investigational pneumococcal vaccine, or<br> planned receipt through study participation.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country;Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country;Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country;Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country;Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country;GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group
- Secondary Outcome Measures
Name Time Method Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country;Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country;GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group;Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country