V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

Phase 3 Completed 403 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.

Timeline

Start: 2006-02
Primary completion: 2006-11
Completion: 2006-11

Outcome

Met primary endpoint

registry p <0.001; Percentage point difference 0.0 (95% CI -3.7 to 3.6) NCT00258154 ↗

registry p = 0.015; Percentage point difference -3.7 (95% CI -9.3 to 1.3) NCT00258154 ↗

paper the immune responses to the antigens of the hexavalent vaccine were noninferior when compared with those of the control group. PMID 19209092 ↗

Publications

Results Ciarlet M, He S, Lai S, Petrecz M, Yuan G, Liu GF, Mikviman E, Heaton PM, Panzer F, Rose T, Koller DY, Van Damme P, Schodel F. Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. Pediatr Infect Dis J. 2009 Mar;28(3):177-81. doi: 10.1097/INF.0b013e31818c0161.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	InfanrixTM hexa	Vaccine	—	Oral
Subject	RotaTeq	Vaccine	—	Oral