Immunogenicity and Reactogenicity of 13-valent Pneumococcal Conjugate Vaccine Among Infants, Toddlers and Children in Bobo-Dioulasso, Burkina Faso: a Phase 4 Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 663
- 试验地点
- 4
- 主要终点
- Serotype-specific pneumococcal serum IgG
研究概览
简要总结
This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination.
The immunogenicity and reactogenicity of PCV13 in the "standard schedule" groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).
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
- None
入排标准
- 年龄范围
- — 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants inclusion criteria
- •Child has birth weight ≥ 2500g
- •Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant
- •Mother has resided in Burkina Faso for at least 2 years
- •Mother has African nationality
- •Child will reside in Bobo-Dioulasso urban area for the duration of the study
- •Parent or guardian has given informed consent for child's participation
排除标准
- •Child was born with a congenital abnormality
- •Child has chronic or acute severe illness requiring specialized medical care
- •Child has a blood coagulation disorder
- •Mother has known HIV infection
- •Child is enrolled in another clinical trial
- •Child has known allergy to a component of the vaccine
- •Child received a pneumococcal vaccine outside the context of the trial
- •Child is 53 days of age or older at 6 week visit
- •Child weighs <3500g at the 6 week visit
- •Blood draw at 6 week visit was unsuccessful after 3 attempts
- •Toddlers inclusion criteria
- •Child is 12 to 15 months of age
- •Child has resided in Burkina Faso since birth
- •Child has African nationality
- •Child will reside in Bobo-Dioulasso urban area for the duration of the study
- •Parent or guardian has given informed consent for child's participation
- •Toddlers exclusion criteria
- •Child has visible signs of severe malnutrition
- •Child has chronic or acute severe illness requiring specialized medical care
- •Child has a blood coagulation disorder
- •Child has known HIV infection
- •Child is enrolled in another clinical trial
- •Child has known allergy to a component of the vaccine
- •Child received a pneumococcal vaccine outside the context of the trial
- •Child's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children (8.0 to 8.7 kg according to age)
- •Blood draw at first vaccination visit was unsuccessful after 3 attempts
- •Children inclusion criteria
- •Child is 2 to 4 years of age
- •Child has resided in Burkina Faso since birth
- •Child has African nationality
- •Child will reside in Bobo-Dioulasso urban area for the duration of the study
- •Parent or guardian has given informed consent for child's participation
- •Children exclusion criteria
- •Child has visible signs of severe malnutrition
- •Child has chronic or acute severe illness requiring specialized medical care
- •Child has a blood coagulation disorder
- •Child has known HIV infection
- •Child is enrolled in another clinical trial
- •Child has known allergy to a component of the vaccine
- •Child received a pneumococcal vaccine outside the context of the trial
- •Child's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children
- •Blood draw at first vaccination visit was unsuccessful after 3 attempts
结局指标
主要结局
Serotype-specific pneumococcal serum IgG
时间窗: 18 weeks for infants
Primary outcome in other age groups is: * 3 months post-dose 1 (toddlers) * 1 month post-vaccination (children)
次要结局
- Serotype-specific pneumococcal serum OPA(18 weeks, 9 months and 10 months (infants), 3 months post-dose 1 (toddlers), 1 month post-vaccination (children))
- Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage(18 weeks, 9 months and 10 months (infants))
- Adverse events following immunization(1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance))
- Serotype-specific serum IgG(in infants, at 9 months and 10 months of age)