Clinical trial on Liquid Rotavirus vaccine to check consistency of different lots of vaccines manufactured and to compare vaccine non-inferiority with ROTASIIL vaccine in healthy children in India

Phase 2/3

Completed

• Conditions: Rotavirus Gastroenteritis

• Registration Number: CTRI/2017/10/010104
• Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary

The study is designed as a phase II/III, open-label, multicenter,randomized, active controlled trial with four groups of infants (n=375 pergroup) receiving one of three different lots of LBRV-PV or ROTASIIL, to compareimmunogenicity of the two formulations and to assess LBRV-PV’s productionconsistency. Three doses of LBRV-PV / ROTASIIL will be administered 4 weeksapart, with the first administration given at 6-8 weeks (42-56 days, both inclusive) of age.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-16
• Study Completion: 2018-06-25
• Last Update Posted: 2018-07-09

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 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 (temporary exclusion).
• 2.Presence of fever on the day of enrollment (temporary exclusion).
• 3.Presence of 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants.	28 days post dose 3

Secondary Outcome Measures

Name	Time	Method
•To evaluate the safety of LBRV-PV in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception.	Throughout the study period

Trial Locations

Locations (9)

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

Government Medical College, Jammu; 🇮🇳 JAMMU, & KASHMIR, India

Hakeem Abdul Hameed Centenary Hospital; 🇮🇳 Delhi, DELHI, India

Institute of Child Health, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Kasturba Medical College, Manipal,; 🇮🇳 Udupi, KARNATAKA, India

Mahatma Gandhi Institute of Medical Sciences, Sewagram,; 🇮🇳 Nagpur, MAHARASHTRA, India

Post Graduate Institute of Medical Education and Research, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Sri Ramachandra Medical Centre, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Vadu Rural Health Program; 🇮🇳 Pune, MAHARASHTRA, India

Bharati Vidyapeeth Medical College and Hospital, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Sanjay K Lalwani

Principal investigator

020-24372789

researchpedpune@gmail.com