NCT00258154

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

Safety and Immunogenicity of Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Rotavirus Vaccine, Live, Oral, Pentavalent	3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
BIOLOGICAL	Comparator: placebo	3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
BIOLOGICAL	Comparator: Infanrix(tm) Hexa	3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-11-24
• Last updated: 2015-10-06
• Results posted: 2009-09-23