Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

Serum Institute of India

Status and phase: Completed; Phase 3

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: ROTARIX + DPT-HepB-Hib + OPV; Biological: BRV-PV Lot A + DPT-HepB-Hib + OPV; Biological: BRV-PV Lot C + DPT-HepB-Hib + OPV; Biological: BRV-PV Lot B + DPT-HepB-Hib + OPV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02584816

ROTA: 04 / VAC-020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,500 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 4 patient groups

Group 1 - BRV-PV Lot A

Experimental group

Description:

BRV-PV Lot A + DPT- HepB-Hib + OPV

Treatment:

Biological: BRV-PV Lot A + DPT-HepB-Hib + OPV

Group 2 - BRV-PV Lot B

Experimental group

Description:

BRV-PV Lot B+ DPT- HepB-Hib + OPV

Treatment:

Biological: BRV-PV Lot B + DPT-HepB-Hib + OPV

Group 3 - BRV-PV Lot C

Experimental group

Description:

BRV-PV Lot C + DPT- HepB-Hib + OPV

Treatment:

Biological: BRV-PV Lot C + DPT-HepB-Hib + OPV

Group 4 - ROTARIX

Active Comparator group

Description:

ROTARIX + DPT-HepB-Hib + OPV

Treatment:

Biological: ROTARIX + DPT-HepB-Hib + OPV