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

INTERVENTION: Two doses of GSK Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration Control: placebo CONDITION: Vaccine/immunization ; Infections and Infestations ; Vaccination PRIMARY OUTCOME: Proportion of subjects who seroconverted at visit 4 (2 months after dose 3) in the vaccine groups. SECONDARY OUTCOME: Immunogenicity:; 1. Proportion of subjects with vaccine take at visit 2 (dose 2) and visit 4 in a subset of subjects; 2. Serum rotavirus IgA (immunoglobulin A) antibody concentrations in all subjects at visits 1, 2 and 4; 3. Proportion of subjects with anti‐poliovirus type 1, 2 and 3 antibody titre greater than or equal to 1:8, at visit 4; 4. Antibody titres for anti‐poliovirus types 1, 2 and 3, at visit 4; 5. Viral shedding in a subset of subjects; ; Safety:; 1. For each type of solicited symptom, occurrence of the symptom within the 15‐day (day 0‐14) solicited follow‐up period after each dose; 2. Occurrence of unsolicited adverse events within 43 days (day 0 ‐ 42) after each dose, according to MedDRA (medical dictionary for adverse events) classification; 3. Presence of rotavirus in diarrhoeal stool collected until visit 4; 4. Occurrence of serious adverse events throughout the entire study period; ; Efficacy:; 1. Occurrence of rotavirus gastroenteritis/severe rotavirus gastroenteritis during the period starting from dose 1 up to visit 5; 2. Occurrence of severe rotavirus gastroenteritis during the entire study period 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. Born after a gestation period of 36 ‐ 42 weeks