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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: TdaP vaccine SSI
* Biological: Td vaccine SSI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TdaP vaccine<br> | Biological: TdaP vaccine SSI<br>* 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)<br>|
| Active Comparator: Td vaccine<br> | Biological: Td vaccine SSI<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunisation, active