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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01033877
First received: December 16, 2009
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: TdaP vaccine SSI
Biological: Td vaccine SSI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples [ Time Frame: one month post-vaccination ] [ Designated as safety issue: No ]
  • Serum anti-diphtheria antibody conc. in post-vac. serum samples [ Time Frame: one month post -vaccination ] [ Designated as safety issue: No ]
  • Serum anti-tetanus antibody conc. in post-vac. serum samples [ Time Frame: one month post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination [ Time Frame: one month post-vaccination ] [ Designated as safety issue: Yes ]
  • Serum anti-diphtheria antibody conc. in pre-vac. serum samples [ Time Frame: one month post-vaccination ] [ Designated as safety issue: Yes ]
  • Serum anti-tetanus antibody conc. in pre-vac. serum samples [ Time Frame: one month post- vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 802
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033877

Locations
Denmark
H:S Rigshospitalet
Copenhagen, Denmark, 2100
aCROnordic
Hoersholm, Denmark, 2970
Sponsors and Collaborators
Statens Serum Institut
Investigators
Study Director: Birgit Thierry-Carstensen, M.Sc. Pharm Statens Serum Institut
Principal Investigator: Carsten Heilmann, Professor MD H:S Rigshospitalet
  More Information

No publications provided by Statens Serum Institut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01033877     History of Changes
Other Study ID Numbers: VTdaP-01
Study First Received: December 16, 2009
Last Updated: January 18, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Reasearch Ethics

Keywords provided by Statens Serum Institut:
Immunisation, active

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on April 17, 2014