Clinical trial NCT02584816: Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Gastroenteritis
Keywords: BRV-PV
Rotavirus vaccine
lot-to-lot consistency
interference with routine immunization
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2015-10-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Detailed description: The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine 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 vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.

Eligibility criteria: 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 written informed consent.
4. Parent who intends to remain in the area with the child during the study period.
5. Receipt of birth dose of Hepatitis B vaccine and OPV.

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. 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.
5. Presence of significant malnutrition or any systemic disorder as determined by medical history and / or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol.
6. History of congenital abdominal disorders, intussusception, or abdominal surgery.
7. Known or suspected impairment of immunological function based on medical history and physical examination.
8. Household contact with an immunosuppressed individual or pregnant woman.
9. Prior receipt or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
10. A known sensitivity or allergy to any components of the study vaccine.
11. Clinically detectable congenital or genetic defect.
12. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
13. Receipt of any immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
14. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
15. History of any neurologic disorders or seizures.
16. 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 written informed consent.

Primary outcomes:
measure: Rotavirus vaccine lots Immunogenicity
timeFrame: Four weeks after the third dose of vaccination
measure: Immunogenicity of UIP vaccines
timeFrame: Four weeks after the third dose of vaccination
Secondary outcomes:
measure: Immediate adverse events and Solicited post -vaccination reactogenicity
timeFrame: AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination
measure: Rotavirus Immunogenicity:
timeFrame: Four weeks after the third dose of vaccination
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Gandhi Medical College and Gandhi Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Mysore
country: India
facility: JSS Medical College and Hospital
state: Karnataka
city: Mumbai
country: India
facility: T. N. Medical College and B. Y. L. Nair Charitable
state: Maharashtra
city: Mumbai
country: India
facility: Seth G S Medical College & KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Bharati Vidyapeeth Medical College and Hospital
state: Maharashtra
city: Pune
country: India
facility: KEM Hospital and Research Centre, Vadu
state: Maharashtra
city: Chennai
country: India
facility: Sri Ramachandra Medical Centre
state: Tamil Nadu
city: Kolkata
country: India
facility: Institute of Child Health
state: West Bengal
city: New Delhi
country: India
facility: Maulana Azad Medical College
Study officials:
affiliation: Serum Institute of India Pvt. Ltd.
name: Dr Prasad Kulkarni, M.D.
role: STUDY_DIRECTOR
References:
citation: Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL(R) with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10.