Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India

NCT ID: NCT03474055

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2018-06-25

Brief Summary

This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.

Conditions

Rotavirus Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LBRV-PV Lot A

The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A).

Group Type: EXPERIMENTAL

Liquid Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

LBRV-PV Lot B

The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B).

Group Type: EXPERIMENTAL

Liquid Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

LBRV-PV Lot C

The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C).

Group Type: EXPERIMENTAL

Liquid Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

ROTASIIL

The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India.

Group Type: ACTIVE_COMPARATOR

Liquid Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

Interventions

Liquid Rotavirus Vaccine

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

ROTASIIL

Eligibility Criteria

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 informed consent.

4. Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria

1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.

2. Acute disease at the time of enrollment (temporary exclusion)

3. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study

4. History of congenital abdominal disorders, intussusception, or abdominal surgery.

5. Known or suspected impairment of immunological function based on medical history and physical examination.

6. History of any neurologic disorders or seizures.

7. 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 informed consent.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Serum Institute of India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,

Udupi, Karnataka, India

KEM Hospital Research Centre

Pune, Maharashtra, India

Bharati Vidyapeeth Medical College and Hospital, Pune

Pune, Maharashtra, India

Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram

Wardha, Maharashtra, India

Hakeem Abdul Hameed Centenary Hospital

New Delhi, National Capital Territory of Delhi, India

Sri Ramachandra Medical Centre, Chennai

Chennai, Tamil Nadu, India

Institute of Child Health, Kolkata

Kolkata, West Bengal, India

Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh, , India

Countries

India

References

Kawade A, Babji S, Kamath V, Raut A, Kumar CM, Kundu R, Venkatramanan P, Lalwani SK, Bavdekar A, Juvekar S, Dayma G, Patil R, Kulkarni M, Hegde A, Nayak D, Garg BS, Gupta S, Jategaonkar S, Bedi N, Maliye C, Ganguly N, Uttam KG, Niyogi P, Palkar S, Hanumante N, Goyal N, Arya A, Aslam M, Parulekar V, Dharmadhikari A, Gaikwad D, Zade J, Desai S, Kang G, Kulkarni PS. Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine. 2019 May 1;37(19):2554-2560. doi: 10.1016/j.vaccine.2019.03.067. Epub 2019 Apr 4.

Reference Type: DERIVED

PMID: 30955982 (View on PubMed)

Other Identifiers

ROTA:06

Identifier Type: -

Identifier Source: org_study_id