CompletedPhase 3

Phase III Study of Liquid Formulation of ROTAVIN

Vietnam825 participantsStarted 2019-03-16

Plain-language summary

This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.

Who can participate

Age range

60 Days – 91 Days

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 before entering the study.
. Age: 60-91 days (both days inclusive) at the time of enrollment.
. Parental/legally acceptable representative ability and willingness to provide written informed consent.
. Parent/legally acceptable representative who intends to remain in the area with the child 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 on the day of enrollment (temporary exclusion).

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

Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination

Timeframe: Day 85 (28 days after the second vaccination)

Number of Participants With Solicited Reactions Within 7 Days of Vaccination

Timeframe: 7 days after each vaccination (Days 1 to 8 and 57 to 64)

Trial details

NCT IDNCT03703336

SponsorCenter for Research and Production of Vaccines and Biologicals, Vietnam

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-01-08

Results submitted2021-01-05

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