NCT02040636

Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) Compared to Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) and Hepatitis B Vaccine Given Concurrently In Adolescents 11-14 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 14 Years
• Healthy volunteers: Accepted

Summary

Primary objective: * To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age. Secondary objective: * To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.

Detailed description

Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2). All participants will be followed up for immunogenicity and safety

Conditions

• Pertussis
• Tetanus
• Diphtheria
• Poliomyelitis
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV	0.5 mL, Intramuscular
BIOLOGICAL	Hepatitis B vaccine	0.5 ml, Intramuscular

Timeline

• Start date: 1999-01-01
• Primary completion: 2000-05-01
• Completion: 2000-05-01
• First posted: 2014-01-20
• Last updated: 2015-03-25

Locations

1 site across 1 country: Canada