CompletedPhase 1

Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults

Vietnam29 participantsStarted 2009-08

Plain-language summary

The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.

Who can participate

Age range18 Years – 40 Years

SexALL

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Exclusion criteria

✕. Pregnant woman or planning to be pregnant during the study period.
✕. Has a chronic disease (cardiovascular, liver, kidney disease).
✕. Acute disease at the time of enrolment.
✕. Administering corticosteroids (\> 1mg/kg/day).
✕. 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.
✕. Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic.
✕. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.

What they're measuring

Safety of Rotavin-M1 vaccine in healthy adult volunteers

Timeframe: 3 months

Trial details

NCT IDNCT01375907

SponsorNational Institute of Hygiene and Epidemiology, Vietnam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10

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