None listed
Conditions
Interventions
Intervention1: ROTAVAC 5C formulation
BBIL-R2014-1: Single dose administered orally as three doses at 4 (+1) weeks interval.
Intervention2: ROTAVAC 5C formulation
BBIL-R2014-2: Single dose administere
antacid buffer (2.5mL/dose
sodium bicarbonate citrate) to be administered 5 min
prior to the vaccine.
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 >=2.5 kgs at birth. 4.Infants received EPI vaccines (OPV, BCG and Hep B) at birth. 5.Parental ability and willingness to provide informed consent. 6.Parent who intends to remain in the area with the participant 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.Concurrent participation in another clinical trial. 4.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 childâ??s health or is likely to result in non-conformance to the protocol. 5.History of congenital abdominal disorders, intussusception, abdominal surgery 6.Known or suspected impairment of immunological function based on medical history and physical examination. 7.Household contact with an immunosuppressed individual or pregnant woman. 8.Prior receipt of rotavirus vaccine. 9.A known sensitivity or allergy to any components of the study vaccines. 10.Major congenital or genetic defect. 11.History of persistent diarrhoea (defined as diarrhoea more than 14 days). 12.Participantâ??s parents not able, available or willing to accept active follow-up by the study staff. 13.Has received any immunoglobulin therapy and/or blood products since birth. 14.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. 15.History of any neurologic disorders or seizures. 16.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
Primary
| Measure | Time frame |
|---|---|
| Exploratory Phase The difference in immunogenicity achieved with two formulations of ROTAVAC 5C will not be statistically significant to that achieved with ROTAVAC®, when administered orally as 3-dose regimen. Safety assessment of ROTAVAC 5C formulations. Confirmatory Phase Establish lot consistency and immunogenicity in each treatment arm at 4-6 weeks after administration of 3rd dose in comparison to baseline levels.Timepoint: Exploratory Phase Baseline and 4-6 weeks post 3rd dose. Confirmatory Phase Baseline, 4-5 weeks post 2nd dose and 4-6 weeks post 3rd dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory phase: Evaluation of shedding of rotavirus. Confirmatory Phase: Assess 4- fold rise in serum anti-rotavirus IgA titers 4-6 weeks after administration of 3rd dose in comparison to baseline titers in all groups. Assess sero response to childhood vaccines Asses vaccine reactogenicity and safety of the two formulations of ROTAVAC 5C and ROTAVAC®. Timepoint: Stool specimen: Day 3 and 7 after each vaccine dose Immunogenicity and Sero-response to childhood vaccines: : Baseline and 4-6 weeks after 3rd dose Safety: Throughout the study period | — |
Countries
India, Viet Nam
Contacts
Public ContactDr Krishna Mohan
Bharat Biotech International Ltd
Outcome results
None listed