Rotavirus Gastroenteritis
Conditions
Keywords
BRV-PV, Rotavirus vaccine, lot-to-lot consistency, interference with routine immunization
Brief summary
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
Detailed description
The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.
Interventions
BIOLOGICALBRV-PV Lot A + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BIOLOGICALBRV-PV Lot B + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BIOLOGICALBRV-PV Lot C + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BIOLOGICALROTARIX + DPT-HepB-Hib + OPV
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
Sponsors
PATH
Serum Institute of India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants as established by medical history and clinical examination before entering the study. 2. Age: 6-8 weeks at the time of enrollment. 3. Parental ability and willingness to provide written informed consent. 4. Parent who intends to remain in the area with the child during the study period. 5. Receipt of birth dose of Hepatitis B vaccine and OPV.
Exclusion criteria
1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion). 2. Presence of fever on the day of enrollment (temporary exclusion). 3. Acute disease at the time of enrollment (temporary exclusion). 4. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study. 5. Presence of significant malnutrition or any systemic disorder as determined by medical history and / or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. 6. History of congenital abdominal disorders, intussusception, or 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 or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed. 10. A known sensitivity or allergy to any components of the study vaccine. 11. Clinically detectable congenital or genetic defect. 12. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer). 13. Receipt of any immunoglobulin therapy and / or blood products since birth or planned administration during the study period. 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 / infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rotavirus vaccine lots Immunogenicity | Four weeks after the third dose of vaccination | Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots. |
| Immunogenicity of UIP vaccines | Four weeks after the third dose of vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate adverse events and Solicited post -vaccination reactogenicity | AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination | — |
| Rotavirus Immunogenicity: | Four weeks after the third dose of vaccination | Serum anti- rotavirus IgA antibody concentrations expressed as GMCs and proportion of subjects with post-vaccination IgA antibody concentration ≥20 U/ml for the comparison of BRV-PV vaccine and licensed rotavirus vaccine. |
Countries
India
Outcome results
None listed