A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
This trial is active, not recruiting.
|Treatments||live attenuated pentavalent (g1-g2-g3-g4-g9) human x bovine reassortant rotavirus vaccine (brv-pv), placebo|
|Sponsor||Serum Institute of India Limited|
|Start date||May 2014|
|End date||March 2016|
|Trial size||7500 participants|
|Trial identifier||NCT02133690, ROTA:03/12|
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|
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|New Delhi, India||Center for Health Research and Development (CHRD) -Society for applied studies (SAS)||no longer recruiting|
|Jammu, India||Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College||no longer recruiting|
|Manipal, India||Kasturba Medical College, Manipal||no longer recruiting|
|Pune, India||KEM Hospital and Research Centre||no longer recruiting|
|Sewagram, India||Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine||no longer recruiting|
|Kolkata, India||National Institute of Cholera & Enteric Diseases||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
occurrence of Severe Rotavirus Gastroenteritis
time frame: Up to 2 years of age of participants
time frame: Until completion of 2 years age of participant
Male or female participants from 6 weeks up to 8 weeks old.
- 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.
- 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.
|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.|
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