None listed
Conditions
Interventions
Intervention1: Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited: 3 doses of 0.5mL at 4 week intervals
Control Intervention1: Placebo: 3 doses of 0.5mL at 4 we
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. At least one parent(s) or legally acceptable representativeâ??s consent for participation and are 2. able to understand study procedures 3. Subjects aged 6 to 7 weeks at recruitment 4. No plans to move in the next 24 months Exclusion Criteria 1. Administration of rotavirus vaccine in the past 2. Presence of any illness requiring hospital referral (temporary exclusion) 3. Known case of immunodeficiency disease, known HIV positive 4. Known case of chronic gastroenteritis disease 5. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems â??illâ??, investigators suspects neglect) 6. Diarrhea on the day of enrollment (temporary exclusion)
Exclusion criteria
Exclusion criteria: 1. Administration of rotavirus vaccine in the past 2. Presence of any illness requiring hospital referral (temporary exclusion) 3. Known case of immunodeficiency disease, known HIV positive 4. Known case of chronic gastroenteritis disease 5. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect) 6. Diarrhea on the day of enrollment (temporary exclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of ORV 116E in comparison to a placebo against severe rotavirus gastroenteritis caused by non vaccine rotavirus will be assessed in all subjects from 14 days following the 3rd dose till the age of 2 yearsTimepoint: 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of ORV for Serious Adverse Events in comparison to a placebo will be assessed in all the subjects, from day of 1st dose till the age of 2 Safety for adverse events in comparison to a placebo will be assessed in first one third of the enrolled subjects in all the three sites, which will be assessed daily in the 2 week period following each dose of the ORV 116E. Safety of ORV for intussusception events in comparison to a placebo will be assessed, from day of 1st dose till the age of 2 Timepoint: Till the age of 2 years (24 months) + up to 14 days;Immunogenicity and Viral Shedding Immunogenicity rates to three doses of the ORV 116E and vaccine virus shedding rates after each of the three doses of the ORV 116E in comparison to a placebo will be ascertained in approximately 150 subjects at each site.Timepoint: Immunogenicity: 4 weeks after the third dose Viral shedding: Day 0, 3, 7 after each dose;Safety 1)Safety of ORV 116E for immediate adverse events and serious adverse events in comparison to a placebo will be assessed in all the subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days. 2)Safety of ORV 116E for adverse events assessed daily in the 2 week period following each dose in comparison to a placebo in first one third of the enrolled subjects in all the three sites 3)Safety of ORV 116E for intussusception events in comparison to a placebo will be assessed in all subjects, from day of 1st dose till the age of 2 years (24 months) + up to 14 days.Timepoint: Till the age of 2 years (24 months) + up to 14 days | — |
Countries
India
Contacts
Public ContactDr GVJA Harshavardhan
Bharat Biotech International Limited
Outcome results
None listed