Status:
COMPLETED
To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
Lead Sponsor:
Bharat Biotech International Limited
Collaborating Sponsors:
Georgia Institute for Clinical Research, LLC
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief 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 p...
Detailed Description
Study Design and plan The study is designed as an adaptive, seamless sequential multicenter, single-blinded, randomized clinical trial with two phases: exploratory phase and confirmatory phase. Explo...
Eligibility Criteria
Inclusion
- 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
- 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.
- History of congenital abdominal disorders, intussusception, abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Household contact with an immunosuppressed individual or pregnant woman.
- Prior receipt of rotavirus vaccine.
- A known sensitivity or allergy to any components of the study vaccines.
- Major congenital or genetic defect.
- History of persistent diarrhoea (defined as diarrhoea more than 14 days).
- Participant's parents not able, available or willing to accept active follow-up by the study staff.
- Has received any immunoglobulin therapy and/or blood products since birth.
- History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- History of any neurologic disorders or seizures.
- Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
Key Trial Info
Start Date :
March 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2016
Estimated Enrollment :
1975 Patients enrolled
Trial Details
Trial ID
NCT04819412
Start Date
March 20 2015
End Date
December 30 2016
Last Update
March 29 2021
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