CTRI/2019/03/017934CompletedPhase 4
Phase IV, Randomized, Multi Centre, Open label Study to Evaluate Lot to Lot consistency of Liquid ROTAVAC 5CM (Live Attenuated Rotavirus Vaccine) as a 3-Dose Series.
Bharat Biotech International Limited6 sites in 1 country384 target enrollmentStarted: April 15, 2019Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 384
- Locations
- 6
- Primary Endpoint
- 1.Establish Lot Consistency across production lots of ROTAVAC 5CM.
Study Overview
Brief Summary
The study is multicenter, open label, randomised clinical trial.
Infants of 6-8weeks of age will randomly be assigned to receive 3 doses of ROTAVAC 5CM(3 Production lots) to evaluate lot consistency.
Active surveillance will be conducted for all participants for seven days after each dose of vaccine to ascertain information on solicited adverse events(Reactogenicity).
Surveillance for unsolicited AEs for all participants will be conducted from the between first dose and 4-6weeks after the 3rd dose.
Surveillance for SAEs for all participants will be conducted from the time between first dose and 4-6weeks after the 3rd dose.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 42.00 Day(s) to 56.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Healthy infants as established by medical history and clinical examination before entering the study.
- •2.Age: 6-8 weeks 3.Weight: ≥2.5 kgs at birth 4.Infants received age-appropriate UIP vaccines till enrolment and during the study.
- •5.Parental ability and willingness to provide informed consent.
- •6.Parent who intends to remain in the area with the subject during the study period.
Exclusion Criteria
- •Any of the following criteria will preclude the participant from being enrolled in the study: 1.Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- •2.Presence of fever on the day of enrolment (temporary exclusion).
- •3.Concurrent participation in another clinical trial.
- •4.Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, 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.
- •5.History of congenital abdominal disorders, intussusception, abdominal surgery.
- •6.Household contact with an immunosuppressed individual or pregnant woman.
- •7.Prior receipt of rotavirus vaccine.
- •8.A known sensitivity or allergy to any components of the study vaccines.
- •10.History of persistent diarrhea (defined as diarrhea of more than 14 days).
- •11.Subject’s parents not able, available or willing to accept active follow-up by the study staff.
- •12.Has received any immunoglobulin therapy and/or blood products since birth.
- •13.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, at the discretion of the principal investigator.
- •14.History of any neurologic disorders or seizures.
- •15.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.
- •16.A subject’s parent’s/legally acceptable representative’s inability to give informed consent.
Outcomes
Primary Outcomes
1.Establish Lot Consistency across production lots of ROTAVAC 5CM.
Time Frame: Day 0 & Day 84
2.GMTs of serum anti rotavirus IgA antibody with three production lots of ROTAVAC 5CM measured on 4-6 weeks after administering of 3rd dose
Time Frame: Day 0 & Day 84
Secondary Outcomes
- 1.4 fold seroconversion(2. Sero response to childhood vaccines)
Investigators
Study Sites (6)
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