NCT04819412

To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus

A Seamless, Sequential Phase III, Randomized, Multi Center Single Blind Study to Evaluate Immunogenicity, Safety, Reactogenicity of Liquid ROTAVAC 5C Vaccine as a 3-dose Series When Compared With ROTAVAC® in Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,975 (actual)
• Sponsor: Bharat Biotech International Limited · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program. * The advantages of the liquid vaccines are: Liquid vaccines take lesser time to administer compared to the current practice of giving antacid buffer prior to vaccine which takes 40% more time to administer. * Easier to transport as it is stable at 2-80C compared to the frozen formulation that needs to be stored at -200C and transported in dry ice. * Chances of human error during administration are lesser than the sequential administration of antacid and vaccine.

Detailed description

Study Design and plan The study is designed as an adaptive, seamless sequential multicenter, single-blinded, randomized clinical trial with two phases: exploratory phase and confirmatory phase. Exploratory phase: 1\. Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of two different formulations of ROTAVAC 5C (BBIL-R2014-1 \&BBILR2014-2) or ROTAVAC®. In this phase, immunogenicity and safety of the two new formulations will be compared with each other and with ROTAVAC® in the three treatment arms when administered at 4 weeks interval (+1week window). The first dose will be administered at 6-8 weeks of age. Each of the rotavirus vaccine formulations contains NLT 105fluorescent focus units (FFU)/Dose. After completion of the exploratory phase, analyses will be undertaken for selection of the most suitable formulation to undergo confirmatory phase of the study. Confirmatory Phase: 1. Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of the selected formulation of ROTAVAC 5C (3 production lots) and ROTAVAC® to evaluate lot consistency. Additionally, non-interference with immune response to antigens contained in childhood vaccines will be evaluated. 2. Active surveillance will be conducted for all participants for seven days after each dose of vaccine to ascertain information on solicited adverse events.("Reactogenicity") 3. Surveillance for unsolicited AEs for all participants will be conducted from the time between first dose and 4-6 weeks after the 3rd dose. Surveillance for SAEs for all participants will be conducted from the time between first dose and 4-6 weeks after the 3rd dose

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	ROTAVAC®	ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer
BIOLOGICAL	ROTAVAC 5C -F1	ROTAVAC 5C formulation BBIL-R2014-1
BIOLOGICAL	ROTAVAC 5C -F2	ROTAVAC 5C formulation BBIL-R2014-2

Timeline

• Start date: 2015-03-20
• Primary completion: 2015-10-30
• Completion: 2016-12-30
• First posted: 2021-03-29
• Last updated: 2021-03-29