NCT00130832

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

Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (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 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.

Conditions

• Rotavirus Infections
• Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Rotavirus Vaccine, Live, Oral, Pentavalent	Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
BIOLOGICAL	Comparator: Oral Poliovirus Vaccine (OPV)	Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
BIOLOGICAL	Comparator: Oral Poliovirus Vaccine (OPV) (staggered)	Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-08-16
• Last updated: 2015-04-01
• Results posted: 2010-09-09