NCT00594347已完成3 期
Immunogenicity and Safety of a Booster Dose of Polysaccharide Pneumococcal Vaccine (Pneumo 23®) in 12 to 18 Months-Old Children Primed With Three Doses of Pneumococcal Conjugate Vaccine (Prevnar®) in Thailand.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine
研究概览
简要总结
The present study intends to investigate the use as a booster of a dose of sanofi pasteur's Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth's Prevnar vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar® at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined vaccine (DTaP-IPV-HB-PRP~T)
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
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12 to 18 months on the day of inclusion
- •Informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local Ethics Committee regulation or/and if the parent/legally acceptable representative is illiterate
- •Child having completed the three-dose primary vaccination of Prevnar® in the hexavalent combined vaccine study (study A3L12).
- •Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures
排除标准
- •Participation in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
- •Planned participation in another clinical study during the present study period
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or to a vaccine containing any of the same substances
- •Chronic illness at a stage that could interfere with study conduct or completion, in the opinion of the investigator
- •Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- •Receipt of any vaccine in the 4 weeks preceding the study vaccination
- •Planned receipt of any vaccine in the 4 weeks preceding or following study vaccination
- •History of seizures Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) antigen or Hepatitis C seropositivity
- •History of pneumococcal infection (confirmed either clinically, serologically or microbiologically)
- •Previous booster vaccination against the pneumococcal disease with either the study vaccine(s) or another vaccine
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- •Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
结局指标
主要结局
To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine
时间窗: 30 days post-vaccination
次要结局
未报告次要终点
研究者
研究点 (2)
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