Wright 1987.
| Methods | Randomization: no details Allocation concealment: code broken at the end of the trial, no further details Blinding: yes, no details Data collection: winter 1984 to spring 1986 Intention to treat: yes Interim analysis: none Exclusion from analysis: none Follow‐up period: 3 days before vaccination and 9 days after vaccination |
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| Participants | Age: 4 to 70 months Health status: no information Breastfeeding: no information Immunization status: no information. |
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| Interventions | 1. Rhesus (MMU18006), 3.6 x 10^4 to 7.5 x 10^6 TCID, single dose (n = 41) 2. Placebo (no details), single dose (n = 39) Sodium bicarbonate tablet or in formula given before vaccine or placebo |
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| Outcomes | 1. Safety: clinical symptoms within 9 days of vaccination 2. Efficacy: fever, gastrointestinal illness, and upper respiratory illness during 2 winter seasons |
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| Notes | Study location: USA Clinical symptoms: clinical evaluation (fever defined as ≥ 38.3 ºC; gastrointestinal illness defined as > 3 stools in 24 h or 1 vomiting in 24 h; upper respiratory tract illness defined as any respiratory sign leading to clinical impression of illness) Laboratory studies: stool analysis by cell culture and ELISA; serology by ELISA, complement fixation, immune adherence haemaglutination, and tube neutralization assays |
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Vaccines: BCG: Bacillus Calmette‐Guerrin vaccine; DTP: diphtheria‐tetanus‐pertussis vaccine; HiB: haemophilus influenza B vaccine; IPV: intramuscular polio vaccine; MMR: measles‐mumps‐rubella vaccine; OPV: oral polio vaccine; RRV: rhesus rotavirus vaccine; RV: rotavirus vaccine; DTCP: diphtheria‐tetanus‐coqueluche‐polio; RRV‐TV: rhesus‐human reassortant rotavirus vaccine.
Institutions: NIH: National Institute of Health; WHO: World Health Organization.
Serology: PFU: plaque‐forming units; ELISA: enzyme‐linked immunosorbent assay; PCR: polymerase chain reaction; SPG: Shirasu porous glass; CF: complement fixation; TCID: tissue culture infectious doses; PAGE‐SS: polyacrylamide gel electrophoresis and silver stain.
IM vaccination: intra‐muscular vaccination; ICAAC: Interscience Conference on Antimicrobial Agents and Chemotherapy HBV: hepatitis B virus.