NCT00352963已完成3 期
Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 22
- 主要终点
- At M7: Antibodies to PRP, MenC HBsAg
研究概览
简要总结
This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.
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 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks).
- •Written informed consent obtained from the parent/guardian of the subject.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
- •Administration of immunosuppressants or other immune-modifying drugs from birth.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
- •Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.
结局指标
主要结局
At M7: Antibodies to PRP, MenC HBsAg
次要结局
- At M6: Abs. to PRP & MenC
- Solicited (D0-3); unsol. events (D0-30); SAEs (full study)
- At M7: Abs. to all vaccine antigens
研究者
研究点 (22)
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