Rotavirus Gastroenteritis Clinical Trial
Official title:
Disease Burden Study and Site Preparation for Planning and Implementation of the Phase III Trials for the Oral Rotavirus Vaccine 116E
This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.
Field workers conducted weekly surveillance in areas allocated to them and identified
pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for
participation through criteria for inclusion and exclusion in the trial were enrolled. Two
cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly
till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and
followed up till 24 months of age (cohort 2=100).
Weekly contact were made by field workers for both the cohorts. At each contact cases of
gastroenteritis were identified. All infants with gastroenteritis were assessed by a field
worker/clinical coordinator. The child was assessed for presence of dehydration, danger
signs. The field worker/clinical coordinator ensured that at least one diarrheal stool
specimen was collected for each episode of gastroenteritis. Infants were treated at the
study clinic or escorted to one of the identified hospitals, if required.
Caregivers of the enrolled infants were explained the signs and symptoms of suspected
intussusception, dehydration and danger signs that require hospital referral and were given
the option to seek care from the study clinic or from one of the identified hospitals in the
vicinity.
Stool specimens were collected in all diarrheal episodes. In a subset of 30 children who
were identified early in a diarrheal episode and who shed rotavirus, multiple stool
specimens were collected in order to assess duration of shedding of rotavirus during a
natural infection.
The study was also designed to collect information on data essential for planning and
implementation of phase III trials pertaining to trial logistics, data collection tools and
validity of questions including those in the Vesikari score.
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Observational Model: Cohort, Time Perspective: Prospective
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