A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Health… (NCT01377571) | Clinical Trial Compass
CompletedPhase 2
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
Vietnam200 participantsStarted 2009-10
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.
Who can participate
Age range6 Weeks – 12 Weeks
SexALL
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Inclusion criteria
✓. A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
✓. Full term gestation (\>=37 weeks).
✓. Birth weight of the subject should be \>=2.5 kg.
✓. Healthy subjects as established by medical history and clinical examination before entering into the study.
✓. Did not use any dose of Rota virus vaccine.
✓. Written informed consent obtained from the parent or guardian of the subject.
✓. Received dose 1.
✓. Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.
Exclusion criteria
✕. Has a chronic disease (cardiovascular, liver, kidney disease).
✕. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
✕. Immunosuppressive or immunodeficient condition.
✕
What they're measuring
1
To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule
Timeframe: up to 7 months
Trial details
NCT IDNCT01377571
SponsorNational Institute of Hygiene and Epidemiology, Vietnam