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

NCT ID: NCT01033877

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 802 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

TdaP vaccine

Group Type: EXPERIMENTAL

TdaP vaccine SSI

Intervention Type: BIOLOGICAL

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

Group Type: ACTIVE_COMPARATOR

Td vaccine SSI

Intervention Type: BIOLOGICAL

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Statens Serum Institut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birgit Thierry-Carstensen, M.Sc. Pharm

Role: STUDY_DIRECTOR

Statens Serum Institut

Carsten Heilmann, Professor MD

Role: PRINCIPAL_INVESTIGATOR

H:S Rigshospitalet

Locations

H:S Rigshospitalet

Copenhagen, , Denmark

aCROnordic

Hoersholm, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 22776216 (View on PubMed)

Other Identifiers

VTdaP-01

Identifier Type: -

Identifier Source: org_study_id