CompletedPhase 3

Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

Vietnam360 participantsStarted 2017-12-20

Plain-language summary

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam

Who can participate

Age range

6 Weeks – 8 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy infants as established by medical history and clinical examination
. Age: 6-8 weeks
. Weight ≥2.5kgs at birth
. Infants receiving EPI vaccines as per Vietnam immunization program
. Parental ability and willingness to provide informed consent.
. Parent who intends to remain in the area with the participant during the study period.

Exclusion criteria

. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
. Presence of fever (\>37.5C) or hypothermia (\<35.5C) on the day of enrollment (temporary exclusion).
. Concurrent participation in another clinical trial.
. Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immuno-logical, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demonstrate immunogenicity of 3-dose regimen of Rotavac

Timeframe: At the end of 28 days after last dose

Trial details

NCT IDNCT04596696

SponsorBharat Biotech International Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-30

View on ClinicalTrials.gov More Rotavirus Gastroenteritis trials