Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Phase 3 Completed 735 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

Timeline

Start: 2005-10
Primary completion: 2006-07
Completion: 2006-07

Outcome

Mixed primary results

paper The poliovirus seroprotection rate in the concomitant-use group was statistically noninferior to the staggered-use group (n = 363). PMID 18756184 ↗

registry p = 0.277; GMT Ratio 0.54 (95% CI 0.42 to 0.69) NCT00130832 ↗

paper The immunoglobulin A (IgA) antirotavirus geometric mean titer was 46% lower in the concomitant-use group than in the staggered-use group. PMID 18756184 ↗

Publications

Results Ciarlet M, Sani-Grosso R, Yuan G, Liu GF, Heaton PM, Gottesdiener KM, Arredondo JL, Schodel F. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine. Pediatr Infect Dis J. 2008 Oct;27(10):874-80. doi: 10.1097/INF.0b013e3181782780.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oral Poliovirus Vaccine	Vaccine	—	Oral
Subject	Rotavirus Vaccine, Live, Oral, Pentavalent	Vaccine	—	Oral