Rotavirus Gastroenteritis Clinical Trial
Official title:
The Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding Around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine
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 licensed in many high and middle income countries in 2006, but lack of
efficacy data in low income countries had prevented WHO from making a universal
recommendation of their use until recently. This study will be conducted in Pakistan and
will look at two objectives:
1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks
of life and at 6, 10 and 14 weeks of life.
2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of
vaccine administration with infants whose breast feeding is withheld for one hour
before and after vaccine administration.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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