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: The intended use of the vaccine in this study is to increase the immunological protection against pertussis in adults who completed primary vaccination with diphtheria, tetanus and pertussis vaccine typically during their childhood.; MedDRA version: 12.0Level: LLTClassification code 10034738Term: Pertussis

• Registration Number: EUCTR2009-013411-36-DK
• Lead Sponsor: Statens Serum Institut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (e.g. Td, TdaP, TdaP-IPV, DTaP, DTaP-IPV or DTaP-IPV/PRP-T) within 5 years before inclusion

5. Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine (e.g. Act-HIB®, NeisVac-C®, Prohibit®, Menectra®, Hib-TITER®, Meningitec®, Menjugate® or Prevenar®) 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified