A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal®) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 试验地点
- 2
- 主要终点
- Anti-hepatitis A virus (HAV) antibody concentrations
研究概览
简要总结
The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).
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
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Original study:
- •Written informed consent obtained from the parent/legal guardian of the subject.
- •Free of obvious health problems as established by medical history and/or clinical examination before entering the study.
- •At least 8 kg of body weight at age of 12 months.
- •Follow-up phase:
- •Subjects enrolled and randomised in the original study and having received two doses of the hepatitis A study vaccines.
排除标准
- •Original study:
- •Children not having received 3 documented doses of DTPaHib and polio vaccines during infancy
- •Children having received a documented dose of MMR during infancy
- •Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Administration of systemic corticosteroids (inhaled and topical steroids are allowed).
- •Administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
- •Previous vaccination against hepatitis A.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness
- •Acute disease at the time of enrolment.
- •Follow-up phase:
- •Children who had received a hepatitis A antigen containing vaccine since the last visit
研究组 & 干预措施
Group A
Epaxal + concomitant administration of DTPaHibIPV, MMR, OPV
干预措施: Epaxal (Biological)
Group B
Epaxal, with administration of DTPaHibIPV, MMR, OPV one month later
干预措施: Epaxal (Biological)
Group C
Havrix 720 + concomitant administration of DTPaHibIPV, MMR
干预措施: Havrix 720 (Biological)
结局指标
主要结局
Anti-hepatitis A virus (HAV) antibody concentrations
时间窗: 7.5 years
Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay
次要结局
- Geometric mean concentrations (GMC)(5.5 and 7.5 years)
- Proportion of seroprotected subjects(5.5 and 7.5 years)