Randomized, Open Label, Active Control, Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 389
- 试验地点
- 4
- 主要终点
- Serum Antibody Titers Against Haemophilus Influenzae Type b.
研究概览
简要总结
The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.
详细描述
Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.
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
- 14 Months 至 19 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy toddlers of both sexes
- •Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
- •Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
- •Informed consent signed by one or both parents who are adequately informed about the study.
排除标准
- •Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
- •Toddlers with severe chronic diseases
- •Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
- •Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
- •Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
- •Toddlers with personal history of convulsions.
- •Toddlers with known bleeding disorder no controlled
- •Toddlers with known congenital or acquired immunodeficiency
- •Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months.
- •A toddler that under investigator opinion is probable to be lost during the follow-up
- •A toddler that is currently included or is planned to be included in any other clinical trial.
- •A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.
研究组 & 干预措施
MENC-CRM/MENC-CRM
Children primed with 3 doses of MenC-CRM vaccine, Intervention: boosted with one dose of MenC-CRM vaccine
干预措施: conjugated polysaccharide menC vaccine (Biological)
MENC-CRM/MENC-TT
Children Primed with three doses of MenC-CRM vaccine. Intervention: boosted with one dose of MenC-TT
干预措施: conjugated polysaccharide menC vaccine (Biological)
MENC-TT/MENC-CRM
Children primovacccinated with two MenC-TT vaccine doses. Intervention: boosted with one dose MenC-CRM vaccine
干预措施: conjugated polysaccharide menC vaccine (Biological)
MENC-TT/MENC-TT
Children primovacccinated with two MenC-TT vaccine doses. Intervention boosted with one dose MenC-TT vaccine
干预措施: conjugated polysaccharide menC vaccine (Biological)
结局指标
主要结局
Serum Antibody Titers Against Haemophilus Influenzae Type b.
时间窗: One year
Serum Bactericidal Activity Against MenC
时间窗: One month after booster dose
次要结局
未报告次要终点