None listed
Conditions
Interventions
Intervention1: ROTAVAC®: SPG Liquid Vaccine 0.5mL will be administered orally as three
doses on day 0, day 28±2 and day 56±2.
without buffer
Intervention2: ROTAVAC®: SPG Liquid Vaccine 0.5mL will
Sponsors
Bharat Biotech International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy infants as established by medical history and clinical examination before entering the study. 2.Age: 6-8 weeks 3.Weight of at least 3kg at birth. 4.Infants received EPI vaccines at birth. 5.Parental ability and willingness to provide informed consent and possible to contact on Phone. 6.Parent who intends to remain in the area with the child during the study period.
Exclusion criteria
Exclusion criteria: 1.Presence of diarrhoea 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.Acute disease at the time of enrolment (temporary exclusion). 4.Concurrent participation in another clinical trial throughout the entire timeframe of this study. 5.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 childâ??s health or is likely to result in non-conformance to the protocol. 6.History of congenital abdominal disorders, intussusception, abdominal surgery 7.Known or suspected impairment of immunological function based on medical history and physical examination. 8.Household contact with an immunosuppressed individual or pregnant woman. 9.Prior receipt of rotavirus vaccine. 10.A known sensitivity or allergy to any components of the study medication. 11.Major congenital or genetic defect. 12.History of persistent diarrhoea (defined as diarrhoea more than 14 days). 13.Participantâ??s parents not able, available or willing to accept active weekly follow-up by the study staff. 14.Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. 15.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. 16.History of any neurologic disorders or seizures. 17.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 participantâ??s parentâ??s/legally acceptable representativeâ??s ability to give informed consent.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited symptoms, any grade 2 or 3 fever, vomiting,diarrhoea, unsolicited adverse events and serious adverse eventsTimepoint: 1.Seroresponses in at least 50% of recipients in all the groups 2.Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination 3.Occurrence of unsolicited AEs for each infant in the entire cohort will be carried out over the period between first vaccination and 28 days after the third vaccination 4.Occurrence of SAEs over the period between vaccination 5.Occurrence of vaccine-related SAEs over the entire duration of the study | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Immunogenicity of a 3-dose series of ROTAVAC® administered orally to prevent severe rotavirus gastroenteritis in healthy Indian infants.Timepoint: Day 0, day 84±7 | — |
Countries
India
Contacts
Public ContactDr B N Patnaik
Bharat Biotech International Ltd
Outcome results
None listed