NCT01033877

Immunogenicity and Safety of Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to Tetanus and Diphtheria (Td) Vaccine When Given as Booster Vaccinations to Adults

Immunogenicity and Safety of a Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to a Tetanus and Diphtheria (Td) Vaccine When Given as a Booster Vaccination to Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 802 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in their childhood. Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is the target population.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	TdaP vaccine SSI	1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: \>= 20 I.U. tetanus toxoid (T), \>=2 I.U. diphtheria toxoid (d), 20 microgram pertussis toxoid (aP)
BIOLOGICAL	Td vaccine SSI	1 vaccine dose of 0.5 mL suspension for injection in a pre-filled syringe: \>= 20 I.U. tetanus toxoid (T), \>=2 I.U. diphtheria toxoid (d)

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-12-17
• Last updated: 2013-01-21

Locations

2 sites across 1 country: Denmark