A Phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent Pneumococcal conjugate vaccine given in a series of 3 infant doses and 1 toddler dose in infants in India and Taiwan.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc.
- 入组人数
- 540
- 试验地点
- 7
- 主要终点
- 2. Proportions of participants with systemic events (fever, decreased appetite drowsiness or increased sleep, and irritability).
研究概览
简要总结
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 to 70 days after Dose 1, and Dose 3 will be given 28 to 70 days after Dose 2. Dose 4 will be given at 365 to 455 days (approximately 12 to 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 42.00 Day(s) 至 84.00 Day(s)（—）
- 性别
- All
入选标准
- •Male or female infants born at ≥36 weeks of gestation and approximately 42 to 84 days 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.
排除标准
- •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.
结局指标
主要结局
2. Proportions of participants with systemic events (fever, decreased appetite drowsiness or increased sleep, and irritability).
时间窗: 1. Day 7 | 2. Day 7 | 3. Dose 1 to 1 month after Dose 3 | 4. Dose 4 to 1 month after Dose 4 | 5. Dose 1 to 1 month after Dose 4 | 6. 1 month after Dose 4
1. Proportions of participants with local reactions (redness, swelling, and pain at the injection site).
时间窗: 1. Day 7 | 2. Day 7 | 3. Dose 1 to 1 month after Dose 3 | 4. Dose 4 to 1 month after Dose 4 | 5. Dose 1 to 1 month after Dose 4 | 6. 1 month after Dose 4
3. Proportions of participants with AEs from Dose 1 through 1 month after Dose 3 in each group
时间窗: 1. Day 7 | 2. Day 7 | 3. Dose 1 to 1 month after Dose 3 | 4. Dose 4 to 1 month after Dose 4 | 5. Dose 1 to 1 month after Dose 4 | 6. 1 month after Dose 4
4. Proportions of participants with AEs from Dose 4 through 1 month after Dose 4 in each group
时间窗: 1. Day 7 | 2. Day 7 | 3. Dose 1 to 1 month after Dose 3 | 4. Dose 4 to 1 month after Dose 4 | 5. Dose 1 to 1 month after Dose 4 | 6. 1 month after Dose 4
5. Proportions of participants with AEs from Dose 4 through 1 month after Dose 4 in each group
时间窗: 1. Day 7 | 2. Day 7 | 3. Dose 1 to 1 month after Dose 3 | 4. Dose 4 to 1 month after Dose 4 | 5. Dose 1 to 1 month after Dose 4 | 6. 1 month after Dose 4
6. Pneumococcal IgG at approximately 1 month after Dose 4 in each group (India participants only)
时间窗: 1. Day 7 | 2. Day 7 | 3. Dose 1 to 1 month after Dose 3 | 4. Dose 4 to 1 month after Dose 4 | 5. Dose 1 to 1 month after Dose 4 | 6. 1 month after Dose 4
次要结局
- Geometric mean concentrations (GMCs) of pneumococcal IgG at approximately 1 month after Dose 3 in each vaccine group(1 month after Dose 3)
- Percentages of participants with predefined serotype specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group(1 month after Dose 3)
- Pneumococcal IgG at approximately 1 month after Dose 4 in each vaccine group((Taiwan participants only))
- Percentages of participants with predefined serotype specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group(1 month after Dose 4)