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

January 18, 2013 updated by: Statens Serum Institut

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

802

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • H:S Rigshospitalet
      • Hoersholm, Denmark, 2970
        • aCROnordic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TdaP vaccine
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)
Active Comparator: Td vaccine
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
Time Frame: one month post-vaccination
one month post-vaccination
Serum anti-diphtheria antibody conc. in post-vac. serum samples
Time Frame: one month post -vaccination
one month post -vaccination
Serum anti-tetanus antibody conc. in post-vac. serum samples
Time Frame: one month post-vaccination
one month post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination
Time Frame: one month post-vaccination
one month post-vaccination
Serum anti-diphtheria antibody conc. in pre-vac. serum samples
Time Frame: one month post-vaccination
one month post-vaccination
Serum anti-tetanus antibody conc. in pre-vac. serum samples
Time Frame: one month post- vaccination
one month post- vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Statens Serum Institut

Investigators

  • Study Director: Birgit Thierry-Carstensen, M.Sc. Pharm, Statens Serum Institut
  • Principal Investigator: Carsten Heilmann, Professor MD, H:S Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTdaP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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