ACTRN12611001212943
Completed
Phase 2
A Phase IIa double-blind, randomised, placebo controlled study of the immunogenicity, safety, tolerability and reactogenicity of three doses of oral RV3-BB Rotavirus Vaccine, with the first dose of vaccine administered either at birth (0-5 days of age) or in infancy.
Murdoch Children's Research Institute (MCRI)0 sites93 target enrollmentNovember 24, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rotavirus Gastroenteritis
- Sponsor
- Murdoch Children's Research Institute (MCRI)
- Enrollment
- 93
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy, full\-term infant, 0\-5 days of age.
Exclusion Criteria
- •Moderate or severe illness, major congenital malformations or genetically determined disease, known or suspected disease of the immune system, household member with severe immunosuppression, exposure to the following in the 4 weeks prior to enrolment (including gestation): glucocorticosteroids, cytotoxic drugs or blood products.
- •Intent to immunise with an investigational vaccine (during the study), or other rotavirus vaccine.
Outcomes
Primary Outcomes
Not specified
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