Vaccine/immunisation Infections and Infestations Vaccination
Conditions
Interventions
Intervention: three doses of GSK Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo
Sponsors
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Documented HIV status of the subject as confirmed by Polymerase Chain Reaction (PCR) 5. HIV asymptomatic and HIV mildly symptomatic 6. Categories N and A according to CDC HIV clinical classification 7. Born after a gestation period of 36 - 42 weeks
Exclusion criteria
Exclusion criteria: 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. Diarrhea 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who report grade "2" or grade "3" fever, vomiting or diarrhoea during the 15-day f/u period after each dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reactogenicity 2. Serious adverse events (SAEs) 3. CD4 count and human immunodeficiency virus (HIV) viral load at screening and visit 4 4. Immunogenicity 5. Rotavirus shedding until ceases 6. Enteric pathogens 7. Immunogenicity of antigens contained in concomitantly administered routine vaccine DTPw-HBV/Hib + OPV | — |
Countries
South Africa
Outcome results
None listed