A double blind, randomised placebo controlled study of the safety, reactogenicity and immunogenicity of two doses of orally administered human rotavirus vaccine (RIX4414) in healthy infants in South Africa
- Conditions
- VaccinationVaccine/immunizationInfections and Infestations
- Registration Number
- ISRCTN37373664
- Lead Sponsor
- World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 285
1. Parents/guardians of subjects who could comply with the protocol requirements (e.g. completion of diary cards, return for follow-up visits)
2. Male or female 6 - 10 weeks of age at the time of first vaccination
3. Written informed consent from parents/guardians
4. Born after a gestation period of 36 - 42 weeks
1. 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
2. Previous routine vaccination except Bacillus Calmette-Guerin (BCG) and hepatits B virus (HBV)
3. Clinically significant history of chronic gastrointestinal tract (GIT) disease including any incorrected congenital malformation of GIT
4. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
5. Acute illness at the time of enrolement
6. Diarrhoea with in 7 days preceding the study vaccination
7. Administration of immunoglobulins and/or blood products since birth or planned during study period
8. Use of any investigational or non-registered drug or vaccine other than study vaccines during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who seroconverted at visit 4 (2 months after dose 3) in the vaccine groups.
- Secondary Outcome Measures
Name Time Method