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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033877
• Other study ID #: VTdaP-01
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2009
• Last updated: January 18, 2013
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: January 2013
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Reasearch Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diphtheria
• Healthy

Intervention

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)
• 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)

Locations

Country	Name	City	State
Denmark	H:S Rigshospitalet	Copenhagen
Denmark	aCROnordic	Hoersholm

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three co-primary outcome measures: Serum anti-PTx antibody conc. in pre- and post-vac. serum samples		one month post-vaccination	No
Primary	Serum anti-diphtheria antibody conc. in post-vac. serum samples		one month post -vaccination	No
Primary	Serum anti-tetanus antibody conc. in post-vac. serum samples		one month post-vaccination	No
Secondary	Three secondary outcome measures: Local and systemic adverse events reported during one month following the vaccination		one month post-vaccination	Yes
Secondary	Serum anti-diphtheria antibody conc. in pre-vac. serum samples		one month post-vaccination	Yes
Secondary	Serum anti-tetanus antibody conc. in pre-vac. serum samples		one month post- vaccination	Yes