drugset / Trial / NCT01700621

Coadministration of Measles-rubella and Rotavirus Vaccines

NCT01700621

Phase 4 Completed 482 enrolled PATH
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2013-01
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Measles-Rubella vaccine Vaccine 0.5 ml Subcutaneous
Subject Rotarix Vaccine 1 ml Oral

Indications