To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caus… (NCT04819412) | Clinical Trial Compass
CompletedPhase 3
To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
1,975 participantsStarted 2015-03-20
Plain-language summary
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.
* The advantages of the liquid vaccines are: Liquid vaccines take lesser time to administer compared to the current practice of giving antacid buffer prior to vaccine which takes 40% more time to administer.
* Easier to transport as it is stable at 2-80C compared to the frozen formulation that needs to be stored at -200C and transported in dry ice.
* Chances of human error during administration are lesser than the sequential administration of antacid and vaccine.
Who can participate
Age range6 Weeks – 8 Weeks
SexALL
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Inclusion criteria
✓. Healthy infants as established by medical history and clinical examination before entering the study.
✓. Age: 6-8 weeks
✓. Weight ≥2.5 kgs at birth.
✓. Infants received EPI vaccines (OPV, BCG and Hep B) at birth.
✓. 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 diarrhoea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
✕. Presence of fever on the day of enrolment (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.
What they're measuring
1
To evaluate the immunogenicity in terms of GMT and four-fold seroconversion