Clinical trial NCT02133690: A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Official title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Gastroenteritis
Keywords: rotavirus
rotavirus vaccine
BRV-PV
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PATH
First posted: 2014-05-08
Enrollment: 7500
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 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.

Detailed description: The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound \> 10%) if the true vaccine efficacy is 50% or higher.

Eligibility criteria: Inclusion Criteria:

* Healthy infants as established by medical history and clinical examination before entering the study.
* Age: 6-8 weeks at the time of enrollment.
* Parental ability and willingness to provide informed consent.
* Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria:

* Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)
* Presence of fever on the day of enrollment (temporary exclusion).
* Acute disease at the time of enrollment (temporary exclusion)
* Concurrent participation in another clinical trial throughout the entire timeframe for this study.
* Presence of significant malnutrition (weight-for-height z-score \<-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) 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. History of congenital abdominal disorders, intussusception or abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination.
* Household contact with an immunosuppressed individual or pregnant woman.
* Prior receipt of rotavirus vaccine.
* A known sensitivity or allergy to any components of the study vaccine.
* Major congenital or genetic defect.
* History of persistent diarrhea (defined as diarrhea more than 14 days).
* Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
* 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.
* History of any neurologic disorders or seizures.
* 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.

Primary outcomes:
measure: occurrence of Severe Rotavirus Gastroenteritis
timeFrame: Up to 2 years of age of participants
Secondary outcomes:
measure: Safety
timeFrame: Until completion of 2 years age of participant
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Center for Health Research and Development (CHRD) -Society for applied studies (SAS)
state: Delhi
city: Jammu
country: India
facility: Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College
state: Jammu & Kashmir
city: Manipal
country: India
facility: Kasturba Medical College, Manipal
state: Karnataka
city: Pune
country: India
facility: KEM Hospital and Research Centre
state: Maharashtra
city: Sewagram
country: India
facility: Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine
state: Maharashtra
city: Kolkata
country: India
facility: National Institute of Cholera & Enteric Diseases
state: West Bengal
Study officials:
affiliation: Serum Institute of India Pvt. Ltd.
name: Prasad Kulkarni, MD
role: STUDY_DIRECTOR
References:
citation: Kulkarni PS, Desai S, Tewari T, Kawade A, Goyal N, Garg BS, Kumar D, Kanungo S, Kamat V, Kang G, Bavdekar A, Babji S, Juvekar S, Manna B, Dutta S, Angurana R, Dewan D, Dharmadhikari A, Zade JK, Dhere RM, Fix A, Power M, Uprety V, Parulekar V, Cho I, Chandola TR, Kedia VK, Raut A, Flores J; SII BRV-PV author group. A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine. 2017 Oct 27;35(45):6228-6237. doi: 10.1016/j.vaccine.2017.09.014. Epub 2017 Sep 26.