Phase III Study of Liquid Formulation of ROTAVIN (NCT03703336) | Clinical Trial Compass
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 range60 Days – 91 Days
SexALL
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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).
✕. Acute disease at the time of enrollment (temporary exclusion).
✕. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study.
✕. Presence of 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 participant's health or is likely to result in nonconformance to the protocol.
✕. History of congenital abdominal disorders, intussusception, or abdominal surgery.
What they're measuring
1
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)
2
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