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

Phase 3 Completed 802 enrolled Statens Serum Institut

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2010-01
Primary completion: 2010-08
Completion: 2010-08

Outcome

Met primary endpoint

paper TdaP was non-inferior to Td in eliciting seroprotective anti-tetanus and diphtheria antibody concentrations PMID 22776216 ↗

Publications

Thierry-Carstensen B, Jordan K, Uhlving HH, Dalby T, Sorensen C, Jensen AM, Heilmann C. A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults. Vaccine. 2012 Aug 10;30(37):5464-71. doi: 10.1016/j.vaccine.2012.06.073. Epub 2012 Jul 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Td vaccine SSI	Vaccine	0.5 ml	—
Subject	TdaP vaccine SSI	Vaccine	0.5 ml	—

Indications

No indication recorded.