RV3-BB Rotavirus Vaccine Phase IIa Clinical Trial of immunogenicity and safety.
Phase 2
Completed
- Conditions
- Rotavirus GastroenteritisInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonPublic Health - Epidemiology
- Registration Number
- ACTRN12611001212943
- Lead Sponsor
- Murdoch Children's Research Institute (MCRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 93
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaccine Take (defined as serum immune response or evidence of vaccine shedding in stool)[Serology assessments will be done on serum collected at baseline, and 28 days after dose 1, dose 3 (full neonatal vaccine schedule) and dose 4 (full infant vaccine schedule). <br>Shedding will be assessed in stool collected in the week after each dose.]
- Secondary Outcome Measures
Name Time Method Solicited adverse events[Solicited Systemic and Gastrointestinal adverse event data will be collected on diary cards in the days 0-7 following each dose. Events will be recorded as they occur.];Serious Adverse Events (SAE) and unsolicited adverse events[Unsolicited adverse event data, including and SAE, will be collected through observation and participant follow-up up from randomisation up to 28 days following the last dose of investigational product. Events will be recorded as they occur.]