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:
Statens Serum Institut
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
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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:
- 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
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 May 16, 2013