NCT01700621

Coadministration of Measles-rubella and Rotavirus Vaccines

Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 9 Months – 11 Months
• Healthy volunteers: Accepted

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.

Conditions

• Measles Antibody Seroconversion
• Rubella Antibody Seroconversion
• Rotavirus Geometric Mean Titer (GMT)
• Rotavirus Immunoglobulin A (IgA) Seropositivity

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix vaccine	one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
BIOLOGICAL	measles-rubella vaccine	one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-10-04
• Last updated: 2019-03-13
• Results posted: 2019-02-18

Locations

1 site across 1 country: Bangladesh