Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.
Primary Outcome Measures:
- Percentage of subjects with vaccine take (i.e. appearance of anti-rota serum IgA and/or presence of rota virus in stool sample) at 2 months after Dose 2.
Secondary Outcome Measures:
- "% of seroconverters (anti-rota IgA post dose 2), RV-IgA concentration, presence of rotavirus in stool samples. Occurrence of solicited symptoms, any grade 2 or 3 fever, vomiting or diarrhea, unsolicited adverse events and serious adverse events .
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Estimated Enrollment: |
450 |
Study Start Date: |
March 2005 |
Assess the effect on immunogenicity of administration of vaccine without buffering agent & assess heat stability in terms of immunogenicity, reactogenicity & safety of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine following a 0,2 m schedule, in healthy infants previously uninfected with human rotavirus