Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam (NCT04596696) | Clinical Trial Compass
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 range6 Weeks – 8 Weeks
SexALL
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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.
✕. History of congenital abdominal disorders, intussusception, abdominal surgery
✕. Known or suspected impairment of immunological function based on medical history and physical examination.
What they're measuring
1
Demonstrate immunogenicity of 3-dose regimen of Rotavac