Status:
COMPLETED
Immunogenicity of Rotavirus Vaccine
Lead Sponsor:
PATH
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were lice...
Eligibility Criteria
Inclusion
- 6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
Exclusion
- Hypersensitivity to any of the vaccine components.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusception or abdominal surgery.
- Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
- Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
- Immunoglobulin and/or blood products use since birth or during the study period.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
1140 Patients enrolled
Trial Details
Trial ID
NCT01199874
Start Date
April 1 2011
End Date
June 1 2013
Last Update
August 30 2013
Active Locations (1)
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1
Aga Khan University
Karachi, Pakistan