An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 247
- 主要终点
- Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
研究概览
简要总结
Primary objective:
To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.
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
- 42 Days 至 55 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants, aged from 6 weeks through full 7 weeks,
- •Consent form signed by at least one parent or by the legal representative properly informed about the study,
- •Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
排除标准
- •History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
- •Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
- •Known or suspected impairment of immunological function,
- •Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
- •Prior administration of any rotavirus vaccine,
- •Prior administration of any vaccine within the 28 days prior to randomisation,
- •Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
- •History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
- •Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- •Clinical evidence of active gastrointestinal illness,
- •Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
- •Infants residing in a household with an immunocompromised person,
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins.
研究组 & 干预措施
Group 1: Concomitant Administration
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age).
干预措施: NeisVac-C® (Biological)
Group 2: Sequential Administration
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
干预措施: NeisVac-C® (Biological)
Group 1: Concomitant Administration
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age).
干预措施: RotaTeq® (Biological)
Group 2: Sequential Administration
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
干预措施: RotaTeq® (Biological)
结局指标
主要结局
Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
时间窗: 28 days after the second dose of MCC vaccine (approximately 20 weeks)
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.
次要结局
未报告次要终点