Overview

This trial is active, not recruiting.

Condition rotavirus gastroenteritis
Treatments live attenuated pentavalent (g1-g2-g3-g4-g9) human x bovine reassortant rotavirus vaccine (brv-pv), placebo
Phase phase 3
Sponsor Serum Institute of India Limited
Collaborator PATH
Start date May 2014
End date March 2016
Trial size 7500 participants
Trial identifier NCT02133690, ROTA:03/12

Summary

This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
3 doses, 4 weeks apart, of Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent
live attenuated pentavalent (g1-g2-g3-g4-g9) human x bovine reassortant rotavirus vaccine (brv-pv)
Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent
(Placebo Comparator)
3 doses, 4 weeks apart, of Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents
placebo
Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents

Primary Outcomes

Measure
occurrence of Severe Rotavirus Gastroenteritis
time frame: Up to 2 years of age of participants

Secondary Outcomes

Measure
Safety
time frame: Until completion of 2 years age of participant

Eligibility Criteria

Male or female participants from 6 weeks up to 8 weeks old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Serum Institute of India Limited.