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

Sponsor

Serum Institute of India Pvt. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02584816

Collaborator

PATH (Other)

1,500

Enrollment

Locations

Arms

Duration (Months)

150

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rotavirus Gastroenteritis	Biological: BRV-PV Lot A + DPT-HepB-Hib + OPV Biological: BRV-PV Lot B + DPT-HepB-Hib + OPV Biological: BRV-PV Lot C + DPT-HepB-Hib + OPV Biological: ROTARIX + DPT-HepB-Hib + OPV	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 - BRV-PV Lot A BRV-PV Lot A + DPT- HepB-Hib + OPV	Biological: BRV-PV Lot A + DPT-HepB-Hib + OPV Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Experimental: Group 2 - BRV-PV Lot B BRV-PV Lot B+ DPT- HepB-Hib + OPV	Biological: BRV-PV Lot B + DPT-HepB-Hib + OPV Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week Other Names: Live Attenuated human-bovine reassortant pentavalent rotavirus vaccine
Experimental: Group 3 - BRV-PV Lot C BRV-PV Lot C + DPT- HepB-Hib + OPV	Biological: BRV-PV Lot C + DPT-HepB-Hib + OPV Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Active Comparator: Group 4 - ROTARIX ROTARIX + DPT-HepB-Hib + OPV	Biological: ROTARIX + DPT-HepB-Hib + OPV Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks to 8 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy infants as established by medical history and clinical examination before entering the study.
Age: 6-8 weeks at the time of enrollment.
Parental ability and willingness to provide written informed consent.
Parent who intends to remain in the area with the child during the study period.
Receipt of birth dose of Hepatitis B vaccine and OPV.

Exclusion Criteria:

Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
Presence of fever on the day of enrollment (temporary exclusion).
Acute disease at the time of enrollment (temporary exclusion).
Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
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.
History of congenital abdominal disorders, intussusception, or abdominal surgery.
Known or suspected impairment of immunological function based on medical history and physical examination.
Household contact with an immunosuppressed individual or pregnant woman.
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.
A known sensitivity or allergy to any components of the study vaccine.
Clinically detectable congenital or genetic defect.
History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
Receipt of any immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
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.
History of any neurologic disorders or seizures.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gandhi Medical College and Gandhi Hospital	Hyderabad	Andhra Pradesh	India	500020
2	King George Hospital	Visakhapatnam	Andhra Pradesh	India	530002
3	JSS Medical College and Hospital	Mysore	Karnataka	India	570004
4	T. N. Medical College and B. Y. L. Nair Charitable	Mumbai	Maharashtra	India	400008
5	Seth G S Medical College & KEM Hospital	Mumbai	Maharashtra	India	400012
6	Bharati Vidyapeeth Medical College and Hospital	Pune	Maharashtra	India	411043
7	KEM Hospital and Research Centre, Vadu	Pune	Maharashtra	India	412216
8	Sri Ramachandra Medical Centre	Chennai	Tamil Nadu	India	600116
9	Institute of Child Health	Kolkata	West Bengal	India	700017
10	Maulana Azad Medical College	New Delhi		India