EUCTR2015-005337-45-Outside-EU/EEA进行中（未招募）不适用
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
SANOFI PASTEUR SA0 个研究点目标入组 448 人开始时间: 2015年12月7日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 448
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged 12 to 18 months on the day of inclusion
- •2. 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
- •3. Child having completed the three-dose primary vaccination of Prevnar® in the
- •hexavalent combined vaccine study (study A3L12)
- •4. Subjects and parent/guardian able to attend all scheduled visits and comply with
- •all study procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 408
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in another clinical study investigating a vaccine, drug, medical
- •device, or a medical procedure in the 4 weeks preceding the study vaccination
- •2. Planned participation in another clinical study during the present study period
- •3. Known or suspected congenital or acquired immunodeficiency
- •immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •4. 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
- •5. Chronic illness at a stage that could interfere with study conduct or completion, in
- •the opinion of the investigator
- •6. Receipt of blood or blood-derived products since birth that might interfere with
- •the assessment of immune response
- •7. Receipt of any vaccine in the 4 weeks preceding the first study vaccination
- •8. Planned receipt of any vaccine in the 4 weeks preceding or following study
- •vaccination
- •9. History of seizures
- •10. Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB)
- •antigen or Hepatitis C seropositivity
- •11. History of pneumococcal infection (confirmed either clinically, serologically or
- •microbiologically)
- •12. Previous booster vaccination against the pneumococcal disease with either the
- •study vaccine(s) or another vaccine
- •13. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
- •inclusion contraindicating IM vaccination
- •14. Febrile illness (temperature =38°C) or moderate or severe acute illness/infection
- •on the day of vaccination, according to investigator judgment
研究者
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