Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

H:S Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female or male adult of ≥ 18 years of age
  • Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
  • Signed informed consent
  • Prepared to grant authorised persons access to medical records
  • Likely to comply with instructions

Exclusion criteria

  • Congenital or acquired immunodeficiency or progressive neurologic disease
  • Uncontrolled epilepsy or progressive encephalopathy
  • Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
  • Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion
  • Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine within 5 years before inclusion
  • Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
  • Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
  • Vaccinated with a live or inactivated vaccine within 1 month before inclusion
  • Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
  • Administration of any investigational drug product or vaccine within 1 month before inclusion
  • Females if pregnant or breastfeeding or not willing to use contraception during the trial

Treatment and study plan

TdaP vaccine SSI

Biological

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)

Td vaccine SSI

Biological

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)

Primary outcomes

  1. Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples

    Time frame: one month post-vaccination

  2. Serum anti-diphtheria antibody conc. in post-vac. serum samples

    Time frame: one month post -vaccination

  3. Serum anti-tetanus antibody conc. in post-vac. serum samples

    Time frame: one month post-vaccination

Secondary outcomes

  1. Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination

    Time frame: one month post-vaccination

  2. Serum anti-diphtheria antibody conc. in pre-vac. serum samples

    Time frame: one month post-vaccination

  3. Serum anti-tetanus antibody conc. in pre-vac. serum samples

    Time frame: one month post- vaccination

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2009
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.