A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 225
- 试验地点
- 39
- 主要终点
- Percentage of participants reporting prespecified local reactions within 7 days after each dose
研究概览
简要总结
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study is partially blinded as 2 of the 3 groups are blinded and 1 is unblinded.
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
- •Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- •Have received 3 infant doses of 20vPnC with the last dose administered >56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- •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 investigational product 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 (other than 20vPnC) or planned receipt during study participation.
研究组 & 干预措施
PG4 1-Dose Group
Participants to receive a single injection of Multivalent Pneumococcal Vaccine
干预措施: PG4 (Biological)
PG4 2-Dose Group
Participants to receive two injections of Multivalent Pneumococcal Vaccine
干预措施: PG4 (Biological)
20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).
干预措施: 20-valent pneumococcal conjugate vaccine (20vPnC) (Biological)
结局指标
主要结局
Percentage of participants reporting prespecified local reactions within 7 days after each dose
时间窗: 7 days after each dose
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination
时间窗: From signing of ICD to 1 month after last assigned vaccination
Adverse events occurring within 1 month after the last assigned vaccination
Percentage of participants reporting prespecified systemic events within 7 days after each dose
时间窗: 7 days after each dose
Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
时间窗: From signing of ICD to 6 months after last assigned vaccination
SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
次要结局
- Pneumococcal serotype specific IgG concentrations(1 month after last assigned vaccination)