NCT00366366已完成3 期
Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose
研究概览
简要总结
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.
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
- 11 Weeks 至 17 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female infant at the age of 11 - 17 weeks.
- •Written informed consent obtained from the parents or guardians of the subject.
- •Free of obvious health problems as established by clinical examination before entering into the study.
- •Hepatitis B vaccine at birth and one month of age.
排除标准
- •Previous vaccination against measles, mumps, rubella and/or varicella.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •A family history of congenital or hereditary immunodeficiency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
- •Major congenital defects.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
结局指标
主要结局
Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose
次要结局
- Ab conc/titers against all vaccine antigens
- Safety: Solicited symptoms, unsolicited AEs and SAEs
研究者
相似试验
已完成
3 期
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTMMeaslesMumpsRubellaVaricellaNCT00969436GlaxoSmithKline450
已完成
3 期
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster VaccineHerpes ZosterNCT05047770GlaxoSmithKline2,013
已完成
3 期
Efficacy, Safety, and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against COVID-19 in AdultsCovid19VaccinesNCT04651790Pontificia Universidad Catolica de Chile2,300
招募中
3 期
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.SplenectomyNCT04166656Assistance Publique - Hôpitaux de Paris84
已完成
4 期
Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B VaccineHepatitis AHepatitis BNCT02445703Sinovac Biotech Co., Ltd301