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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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
TdaP vaccine SSI
Td vaccine SSI
Sponsored by
Statens Serum Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Immunisation, active

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • H:S Rigshospitalet
  • aCROnordic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TdaP vaccine

Td vaccine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2009
Last Updated
January 18, 2013
Sponsor
Statens Serum Institut
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1. Study Identification

Unique Protocol Identification Number
NCT01033877
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Statens Serum Institut

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Immunisation, active

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
802 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TdaP vaccine
Arm Type
Experimental
Arm Title
Td vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
TdaP vaccine SSI
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Td vaccine SSI
Intervention Description
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 Outcome Measure Information:
Title
Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples
Time Frame
one month post-vaccination
Title
Serum anti-diphtheria antibody conc. in post-vac. serum samples
Time Frame
one month post -vaccination
Title
Serum anti-tetanus antibody conc. in post-vac. serum samples
Time Frame
one month post-vaccination
Secondary Outcome Measure Information:
Title
Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination
Time Frame
one month post-vaccination
Title
Serum anti-diphtheria antibody conc. in pre-vac. serum samples
Time Frame
one month post-vaccination
Title
Serum anti-tetanus antibody conc. in pre-vac. serum samples
Time Frame
one month post- vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Thierry-Carstensen, M.Sc. Pharm
Organizational Affiliation
Statens Serum Institut
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carsten Heilmann, Professor MD
Organizational Affiliation
H:S Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
H:S Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
aCROnordic
City
Hoersholm
ZIP/Postal Code
2970
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22776216
Citation
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.
Results Reference
derived

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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

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