a clinical trial to study the effect and safety of rotavirus vaccine against severe rotavirus gastroenteritis in healthy indian infants

Conditions: Rotavirus Gastroenteritis

Summary: this is a phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.

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.

Keywords: rotavirus rotavirus vaccine brv-pv