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

Rotavirus Gastroenteritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474055
• Other study ID #: ROTA:06
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 30, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: September 2018
• Source: Serum Institute of India Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Biological:
• Liquid Rotavirus Vaccine
Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research, Chandigarh	Chandigarh
India	Sri Ramachandra Medical Centre, Chennai	Chennai	Tamil Nadu
India	Institute of Child Health, Kolkata	Kolkata	West Bengal
India	Hakeem Abdul Hameed Centenary Hospital	New Delhi	Delhi
India	Bharati Vidyapeeth Medical College and Hospital, Pune	Pune	Maharashtra
India	KEM Hospital Research Centre	Pune	Maharashtra
India	Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,	Udupi	Karnataka
India	Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram	Wardha	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Serum Institute of India Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of rotavirus vaccine	Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL	28 days post dose 3
Secondary	Immunogenicity Endpoints	GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.	28 days post dose 3
Secondary	Immunogenicity Endpoints	Proportion of subjects achieving IgA antibody concentration =20 U/ml for the comparison of LBRV-PV and ROTASIIL.	28 days post dose 3