NCT00287092

Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Compared To Infanrix®-IPV+Hib When Both Vaccines Are Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 807 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 80 Days – 120 Days
• Healthy volunteers: Accepted

Summary

Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.

Conditions

• Pertussis
• Diphtheria
• Tetanus
• Poliomyelitis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	DT5aP-IPV-Hib 5-component Pertussis vaccine	0.5 mL, IM
BIOLOGICAL	Infanrix® -IPV+Hib	0.5 mL, IM

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-05-01
• Completion: 2008-09-01
• First posted: 2006-02-06
• Last updated: 2015-01-07

Locations

14 sites across 2 countries: Finland, Sweden