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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

Primary Purpose

Rotavirus Gastroenteritis

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Liquid Rotavirus Vaccine

About this trial

This is an interventional treatment trial for Rotavirus Gastroenteritis focused on measuring Liquid rotavirus vaccine, LBRV-PV, Gastroenteritis, Diarrhoea

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.
Acute disease at the time of enrollment (temporary exclusion)
Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
History of congenital abdominal disorders, intussusception, or abdominal surgery.
Known or suspected impairment of immunological function based on medical history and physical examination.
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 informed consent.

Sites / Locations

Hakeem Abdul Hameed Centenary Hospital
Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
KEM Hospital Research Centre
Bharati Vidyapeeth Medical College and Hospital, Pune
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Sri Ramachandra Medical Centre, Chennai
Institute of Child Health, Kolkata
Post Graduate Institute of Medical Education and Research, Chandigarh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

LBRV-PV Lot A

LBRV-PV Lot B

LBRV-PV Lot C

ROTASIIL

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Immunogenicity of rotavirus vaccine

Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL

Secondary Outcome Measures

Immunogenicity Endpoints

GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.

Immunogenicity Endpoints

Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.

Full Information

NCT ID

NCT03474055

First Posted

February 11, 2018

Last Updated

September 7, 2018

Sponsor

Serum Institute of India Pvt. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03474055

Brief Title

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

Official Title

A Phase II/III, Multicenter, Open-Label, Randomized Study of 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 30, 2017 (Actual)

Primary Completion Date

June 25, 2018 (Actual)

Study Completion Date

June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Serum Institute of India Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotavirus Gastroenteritis

Keywords

Liquid rotavirus vaccine, LBRV-PV, Gastroenteritis, Diarrhoea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LBRV-PV Lot A

Arm Type

Experimental

Arm Description

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

Arm Title

LBRV-PV Lot B

Arm Type

Experimental

Arm Description

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

Arm Title

LBRV-PV Lot C

Arm Type

Experimental

Arm Description

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

Arm Title

ROTASIIL

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Liquid Rotavirus Vaccine

Other Intervention Name(s)

ROTASIIL

Intervention Description

Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

Primary Outcome Measure Information:

Title

Immunogenicity of rotavirus vaccine

Description

Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL

Time Frame

28 days post dose 3

Secondary Outcome Measure Information:

Title

Immunogenicity Endpoints

Description

GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.

Time Frame

28 days post dose 3

Title

Immunogenicity Endpoints

Description

Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.

Time Frame

28 days post dose 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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 informed consent. Parent who intends to remain in the area with the child during the study period. Exclusion Criteria: Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment. Acute disease at the time of enrollment (temporary exclusion) Concurrent participation in another clinical trial at any point throughout the entire time frame for this study History of congenital abdominal disorders, intussusception, or abdominal surgery. Known or suspected impairment of immunological function based on medical history and physical examination. 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 informed consent.

Facility Information:

Facility Name

Hakeem Abdul Hameed Centenary Hospital

City

New Delhi

State/Province

Delhi

Country

India

Facility Name

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

City

Udupi

State/Province

Karnataka

ZIP/Postal Code

576104

Country

India

Facility Name

KEM Hospital Research Centre

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411028

Country

India

Facility Name

Bharati Vidyapeeth Medical College and Hospital, Pune

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411043

Country

India

Facility Name

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

City

Wardha

State/Province

Maharashtra

ZIP/Postal Code

442102

Country

India

Facility Name

Sri Ramachandra Medical Centre, Chennai

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600116

Country

India

Facility Name

Institute of Child Health, Kolkata

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700017

Country

India

Facility Name

Post Graduate Institute of Medical Education and Research, Chandigarh

City

Chandigarh

ZIP/Postal Code

160012

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30955982

Citation

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.

Results Reference

derived

Learn more about this trial

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

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