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 range6 Weeks – 8 Weeks
SexALL
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Inclusion criteria
âś“. Healthy infant as established by medical history and clinical examination before entering the study.
âś“. Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
âś“. Infants received age-appropriate EPI vaccines till enrolment.
âś“. Ability and willingness to provide informed consent as per local consenting procedures.
âś“. Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.
Exclusion criteria
âś•. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
âś•. Presence of fever on the day of enrolment (temporary exclusion).
âś•. Acute disease at the time of enrolment (temporary exclusion).
âś•. Concurrent participation in another clinical trial throughout the entire timeframe of this study.
âś•. Presence of severe malnutrition (weight-for-height z-score \< -3SD median).
âś•. 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.
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