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.
A Phase 1 double-blind, randomized study to compare the safety, tolerability and immunogenicity of oral RV3-BB Rotavirus vaccine and Placebo in infants, children and male adults.
Murdoch Childrens Research Institute
60 participants
Jan 27, 2010
Interventional
Conditions
Summary
The primary purpose of the study is to assess the safety and tolerability of one oral dose of a human rotavirus vaccine, RV3-BB, in three successive age groups starting with adult men aged 18-50 years, progressing to children aged 3-8 years and then infants 6-8 weeks. Assessing rotavirus immunity, via serologic markers and faecal extracts, is a secondary objective.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Locations(1)
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ACTRN12610000525088