A Phase 1 randomized study to compare the safety and immune response of an oral rotavirus vaccine, RV3-BB, and placebo for the prevention of rotavirus disease in infants, children and male adults.

INTERVENTION: Each 1 ml of live attenuated human rotavirus vaccine, RV3‐BB, (at a concentration of 8.3 x 10^6 focus formatting units (FFU)/ml) is a cell free solution containing attenuated rotavirus particles in a 10% sucrose/cell culture medium. When vaccine administered: Cohort 1: 1 ml oral dose administered once to male adults aged 18‐50 years inclusive; Cohort 2: 1 ml oral dose administered once to male and female children aged 3‐8 years inclusive; Cohort 3: 1 ml oral dose administered once to male and female infants aged 6‐8 weeks inclusive. Mode of administration: Oral sterile aqueous solution for oral administration. CONDITION: Rotavirus gastroenteritis PRIMARY OUTCOME: 1. To assess the safety and tolerability of RV3‐BB Vaccine (8.3 x 106 focus formatting units (FFU/ml)) in 3 age groups (adult males [18‐50 years]; children [3‐8 years] and infants [6‐8 weeks]) compared to Placebo. Possible adverse events include:gastrointestinal events ie nausea, vomiting/possetting, diarrhoea/loose bowel actions, colic, abdominal discomfort/pain/cramps or systemic events, including unsettled/irritability, decreased appetite, arthalgia, headache and fever requiring antipyretic medication. SECONDARY OUTCOME: 1. To assess the effect of a single dose of RV3‐BB Rotavirus Vaccine upon serologic markers of rotavirus immunity (immunoglobulin G (IgG) and immunoglobulin A (IgA), neutralising antibodies (NA's)). 2. To determine the presence of RV3‐BB Rotavirus Vaccine in faecal extracts, as a marker of viral replication. INCLUSION CRITERIA: 1. Must fit one of the age cohorts at the time of randomisation: (a) Cohort 1: adult males, aged between 18 and 50 years inclusive; or (b) Cohort 2: children (males and females) aged 3‐8 years inclusive; or (c) Cohort 3: infants (males and females) aged 6‐8 weeks inclusive. 2. Participants must be in good health as determined by a baseline (Screening) medical history, physical examination, and haematology and clinical chemistry parameters which confirm the absence of a current or past significant disease state, and clinical judgement; 3. Participant or parent(s)/guardian(s) will be available for the duration of the study, and agrees to adhere to all protocol requirements; 4. Participant or parent(s)/guardian(s) have provided written informed consent prior to undergoing any study‐related procedures; 5. Adult male participants must use a reliable method of contraception (i.e., condoms or abstinence) for the duration of the study, or be in