A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
- Conditions
- Pneumococcal Disease
- Interventions
- Registration Number
- NCT05512819
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers.
This study is enrolling participants who are:
* Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study
* Have a bodyweight of at least 3 kg
Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age.
Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 401
- Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
- Weight of 3.0 kg or greater at the time of randomization
- 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.
- Major known congenital malformation or serious chronic disorder
- 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
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine (20vPnC) 13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine (13vPnC)
- Primary Outcome Measures
Name Time Method Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country Day 7 Prompted systemic reactions after each dose
Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country Day 7 Prompted local reactions after each dose
Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country Dose 4 to 1 month after Dose 4 Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group
Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country Dose 1 to 1 month after Dose 4 SAEs occurring up to 1 month after Dose 4 in each group
GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group 1 month after Dose 4 IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only
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 Dose 1 to 1 month after Dose 3 Adverse events occurring from Dose 1 to 1 month after Dose 3 in each 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 1 month after Dose 3 IgG GMCs for the 20vPnC serotypes 1 month after Dose 3
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 1 month after Dose 3 IgG concentrations for 20vPnC serotypes 1 month after Dose 3
GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group 1 month after Dose 4 IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only
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 1 month after Dose 4 IgG concentrations for 20vPnC serotypes 1 month after Dose 4
Trial Locations
- Locations (11)
Maulana Azad Medical College and Associated with Lok Nayak Hospital
🇮🇳New Delhi, Delhi, India
Nirmal Hospital Pvt Ltd.
🇮🇳Surat, Gujarat, India
BGS Global Institute of Medical Sciences (BGSGIMS)
🇮🇳Bangalore, Karnataka, India
Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
🇮🇳Pune, Maharashtra, India
Jawahar Lal Nehru Medical College
🇮🇳Ajmer, Rajasthan, India
Institute of Child Health
🇮🇳Kolkata, WEST Bengal, India
Hsinchu Mackay Memorial Hospital
🇨🇳Hsinchu City, Hsinchu, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan