Title:    A Phase III, multicenter, open-label, randomized study of bovine rotavirus pentavalent vaccine (BRV-PV) to evaluate lot-to-lot consistency and to investigate potential interference with routine UIP vaccinations in healthy infants in India.

Sponsor and Investigators:

  • Serum Institute of India Pvt Ltd-Sponsor
  • Dr. Anand Kawade - Principal Investigator
  • Dr. Ashish Bavdekar and Dr.Sanjay Juvekar- Co-investigator


Preparatory Phase:
Community awareness activities were conducted before enrollment started with residents of the pre-defined study area, local formal and informal leaders to get support for the study. 8 referral hospitals are identified from study areas which have required facilities and those who agree to the terms and conditions for participation.

Data Collection for Potential Participants:
Using the Health and Demographic Survelliance System (HDSS) data, field research assistants of the study team visited PHCs, Gram Panchayat and private hospitals to collect the data for ANC and birth. R-15 and R-16 registers are also being used for the collection of the data.

Study Site:
The Vadu Rural Health Program (VRHP) is functional in 22 villages in Pune district. Currently the project is functional at Vadu and Kedgaon. The study clinic situated at Kedgaon is 57 km from central study site and 61 km from Pune city. The study clinics are well connected by national highway and railway. Daily 2 clinics are conducting at Vadu and Kedgaon and approximately 5-6 participants are being recruited per clinic to achieve enrollment target of approximately 400 participants in 3 months. Total recruitment for this study is 1500participants across ten sites.

Study Design: 
The study is designed to evaluate lot to lot consistency in the manufacture of BRV-PV by testing the vaccine three doses administered 4 weeks apart, starting at 6-8 weeks of age in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of BRV-PV with UIP vaccines that will be administered concurrently OPV, DPT, Hib,Hep B vaccines and IPV single dose at 14 weeks of age by assessing noninferiority in the immune responses to those vaccines when administered with/without the study vaccine. Blood sample will be obtained from all the participating infants four weeks after the third vaccination to evaluate immune responses to rotavirus vaccine and to UIP vaccines [OPV, DPT-HepB-Hib and IPV (single dose at14 weeks of age)].Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination will be conducted on all infants. In addition, surveillance for unsolicited AEs, SAEs including intussusception will be carried out over the period between enrollment and four weeks after the third vaccination on all infants.

Study Objectives :

  • To demonstrate manufacturing consistency of BRV-PV by evaluating the immunogenicity of three cGMP lots.
  • To demonstrate the immunological non-inferiority of UIP vaccines when co-administered with the BRV-PV as compared to their co-administration with a licensed rotavirus vaccine.
  • To evaluate the safety of BRV-PV given concomitantly with UIP vaccines in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception.
  • To compare the immunogenicity of BRV-PV vaccine and licensed <>rotavirus vaccine.


Study Population and duration :

  • 1,500 healthy male or female infants aged 6-8 weeks at time of enrollment.
  • Expected duration for this study is approximately 12-15 months.
  • Duration of subject participation is 3-3.5 months.


Safety Follow-up:
For safety follow up all enrolled participants are being closely followed for any solicited adverse event after each dose of IP/ comparator. Post immunization diary card are provided to the parents and appropriate training to record solicited reaction such as fever, vomiting, diarrhea, decreased appetite, decreased activity level and irritability in the post immunization diary card is given to the parents by the study staff. All AE's identified during the 7 days following each dose of the IP/comparator will be followed till resolution or stabilization. The parents are also requested to inform the study team about any AE's especially intussusceptions, SAEs and intake of any medications from randomization to 28 days after third dose. All study participants are monitored throughout the study period for any adverse event including solicited and unsolicited. All SAEs occurring during study period are reported as per the applicable regulatory guideline.

Study Endpoints :
Vaccine immunogenicity will be tested on a single serum sample obtained four weeks after the third vaccination in rotavirus immunogenicity, serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV lot consistency evaluation and Immunogenicity of UIP vaccines. For immunogenicity for poliovirus serotypes testing would be conducted using validated micro neutralization assay. For diphtheria, tetanus, pertussis, hepatitis B and Hib testing will be done by ELISA using commercially available kits.

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