NCT01491087

Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Days – 74 Days
• Healthy volunteers: Accepted

Summary

The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces. Primary Objective * To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.

Detailed description

Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period. The duration of each participant in the trial will be approximately 3 to 4 months.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Polio

Interventions

Type	Name	Description
BIOLOGICAL	DTacP IPV//PRP~T combined vaccine: PENTAXIM®	0.5 mL, Intramuscular

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2011-12-13
• Last updated: 2013-03-29

Locations

3 sites across 1 country: China