Status:
COMPLETED
Improving Rotavirus Vaccine Immune Response
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
European Centre for Disease Prevention and Control, SE-171, Stockholm
The Swedish Institute for Infectious Disease Control, SE-171 82 SOLNA
Conditions:
Healthy Infants
Mothers
Eligibility:
All Genders
1-45 years
Phase:
PHASE3
Brief Summary
Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide and is estimated to account for 600,000 deaths in children \<5 years of age. However, live oral enteric...
Detailed Description
The study will be conducted in a suburb of Dhaka in the area of Mirpur. Mirpur is one of the 14 Thanas of Dhaka cities with a population of about one million in an area of 59 square kilometers. Mirpur...
Eligibility Criteria
Inclusion
- male or female,
- aged 6 weeks at the time of enrollment,
- written informed consent,
- free of chronic or serious medical condition as determined by history and physical exam and plan to stay in community for at least 6 months
Exclusion
- fever (\>38 C),
- acute or chronic illness,
- use of antimicrobial drug within previous 14 days,
- hypersensitivity to any of the vaccine components (see vaccine composition),
- use of any investigational drug during previous 30 days,
- any uncorrected congenital malformation of the gastrointestinal tract,
- use of any immunosuppressing drugs during the last 14 days (likelihood is remote),
- any evidence by physical exam of immunosuppresing condition,
- administration of gamma globulin or any other blood product,
- previous intussusception or abdominal surgery.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01825109
Start Date
July 1 2010
End Date
December 1 2011
Last Update
April 5 2013
Active Locations (1)
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1
Mirpur
Dhaka, Bangladesh, 1216