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

Phase 3

Completed

• Conditions: Rotavirus Gastroenteritis
• Interventions: 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

• Registration Number: NCT02584816
• Lead Sponsor: Serum Institute of India Pvt. Ltd.

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.

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-23
• Study Start: 2015-11
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - BRV-PV Lot A	BRV-PV Lot A + DPT-HepB-Hib + OPV	BRV-PV Lot A + DPT- HepB-Hib + OPV
Group 2 - BRV-PV Lot B	BRV-PV Lot B + DPT-HepB-Hib + OPV	BRV-PV Lot B+ DPT- HepB-Hib + OPV
Group 3 - BRV-PV Lot C	BRV-PV Lot C + DPT-HepB-Hib + OPV	BRV-PV Lot C + DPT- HepB-Hib + OPV
Group 4 - ROTARIX	ROTARIX + DPT-HepB-Hib + OPV	ROTARIX + DPT-HepB-Hib + OPV

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Immediate adverse events and Solicited post -vaccination reactogenicity	AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination

Trial Locations

Locations (10)

King George Hospital; 🇮🇳 Visakhapatnam, Andhra Pradesh, India

Bharati Vidyapeeth Medical College and Hospital; 🇮🇳 Pune, Maharashtra, India

Institute of Child Health; 🇮🇳 Kolkata, West Bengal, India

JSS Medical College and Hospital; 🇮🇳 Mysore, Karnataka, India

T. N. Medical College and B. Y. L. Nair Charitable; 🇮🇳 Mumbai, Maharashtra, India

KEM Hospital and Research Centre, Vadu; 🇮🇳 Pune, Maharashtra, India

Maulana Azad Medical College; 🇮🇳 New Delhi, India

Gandhi Medical College and Gandhi Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India

Sri Ramachandra Medical Centre; 🇮🇳 Chennai, Tamil Nadu, India

Seth G S Medical College & KEM Hospital; 🇮🇳 Mumbai, Maharashtra, India