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
- 已完成
- 发起方
- Pfizer
- 入组人数
- 541
- 试验地点
- 11
- 主要终点
- Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country
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 28-70 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Days 至 84 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
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.
研究组 & 干预措施
20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine (20vPnC)
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine (13vPnC)
干预措施: 13-valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Dose 1 to 1 month after Dose 3
Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group
次要结局
- 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)
- 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)
- GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group(1 month after Dose 4)
- 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)