NCT00453570

Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 60 Days – 74 Days
• Healthy volunteers: Accepted

Summary

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP\~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib	0.5 mL, IM
BIOLOGICAL	Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib	0.5 mL, IM
BIOLOGICAL	Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed	0.5 mL, IM

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2007-03-29
• Last updated: 2012-04-17

Locations

1 site across 1 country: China