At a glance
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Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
In Brief
A Phase 4 clinical trial evaluating Rotarix vaccine and measles-rubella vaccine for Measles Antibody Seroconversion and 3 related conditions. Completed, enrolled 482 participants across 1 site.
Detailed Summary
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of \>=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
Study Details
Timeline
Interventions
one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine