Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia (NCT03602053) | Clinical Trial Compass
CompletedPhase 2/3
Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia
Zambia450 participantsStarted 2019-01-22
Plain-language summary
The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks 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 with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.
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 infant as established by medical history and clinical examination before entering the study.
. Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
. Infants received age-appropriate EPI vaccines till enrolment.
. Ability and willingness to provide informed consent as per local consenting procedures.
. Parent can be contacted on phone and confirms intention to remain in the study 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 enrolment (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
1
Geometric Mean Concentration Using WC3 as the Viral Lysate
Timeframe: 28 day after last dose of the study vaccine
Trial details
NCT IDNCT03602053
SponsorCentre for Infectious Disease Research in Zambia
. Presence of fever on the day of enrolment (temporary exclusion).
. Acute disease at the time of enrolment (temporary exclusion).
. Concurrent participation in another clinical trial throughout the entire timeframe of this study.
. Presence of severe malnutrition (weight-for-height z-score \< -3SD median).
. Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, 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.
. History of congenital abdominal disorders, intussusception, abdominal surgery
. Known or suspected impairment of immunological function based on medical history and physical examination.