A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 356
- 试验地点
- 36
- 主要终点
- Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
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 toddlers who had 2 prior doses of Prevnar 13.
This study is being conducted in children who:
- are between 12 to 23 months of age;
- are healthy as determined by the study doctors;
- have received 2 doses of Prevnar 13 during the first year in life.
Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.
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)
盲法说明
The study is partially masked. Participants randomized to receive 2 doses of 20vPnC will not have treatment masking. Participants randomized to receive 1 dose of 20vPnC or 13vPnC will have treatment masking.
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female toddlers ≥12 to <24 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
- •2 infant doses of Prevenar 13 prior to 12 months of age
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 chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation
研究组 & 干预措施
1-Dose 20vPnC Group
Pneumococcal conjugate vaccine
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
13vPnC Group
Pneumococcal conjugate vaccine
干预措施: 13-valent pneumococcal conjugate vaccine (Biological)
2-Dose 20vPnC Group
Pneumococcal conjugate vaccine (2 doses approximately 2 months apart)
干预措施: 20-valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
时间窗: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
Local reactions included redness, swelling, and pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
时间窗: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C,\>38.4 to 38.9 degree C,\>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper \& Pearson method.
Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination
时间窗: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CI was based on the Clopper and Pearson method. AEs reported in this endpoint excluded local reactions and systemic events collected from an e-diary.
Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination
时间窗: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method.
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
时间窗: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method.
次要结局
- Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination(1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1))
- Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination(1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1))
- Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination(1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1))