RV1 ISRCTN86632774

Trial name or title	"A phase II, double blind randomized, placebo controlled study to assess the safety reactogenicity and immunogenicity of three doses of GSK Biologicals (South Africa)"
Methods	"randomized, controlled study with three parallel groups with balanced allocation (1:1:1)"
Participants	Target number: 271 Description: participants' parents/guardians who could comply with the protocol requirements (e.g. completion of diary cards, return for follow‐up visits); male or female aged 6 to 10 weeks of age at the time of first vaccination; written informed consent from parents/guardians; born after a gestation period of 36 to 42 weeks
Interventions	1. RIX4414 (RV1): 2 doses vaccine at 106.5 CCID50 viral concentration plus 1 dose of placebo 2. Placebo: 3 doses
Outcomes	1. Seroprotection for each polio serotype (primary) 2. Vaccine take 3. Viral shedding 4. Presence of rotavirus in diarrhoeal stools 5. Anti‐poliovirus antibody titres 6. Serum anti‐rotavirus immunoglobulin A (IgA) antibody titres 7. Solicited symptoms 8. Unsolicited adverse events 9. Serious adverse events
Starting date	1 January 2001 Anticipated end date: 1 January 2003, completed
Contact information	Dr Duncan Steele (steeled@who.int), WHO
Notes	Location: South Africa Registration number: ISRCTN86632774 Source of funding: RAPID trials (USA); WHO (Switzerland)