NCT01003431

A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.

Conditions

• Rotavirus Gastroenteritis
• Diphtheria
• Tetanus
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Rotavirus Vaccine, Live, Oral, Pentavalent	\[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)\] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
BIOLOGICAL	Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)	Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
BIOLOGICAL	Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)	Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2009-10-28
• Last updated: 2015-10-09