NCT01033877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
802

participants targeted

Target at P75+ for phase_3 healthy

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

December 16, 2009

Last Update Submit

January 18, 2013

Conditions

Healthy

Keywords

Immunisation, active

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

TdaP vaccine

EXPERIMENTAL
Biological: TdaP vaccine SSI

Td vaccine

ACTIVE COMPARATOR
Biological: Td vaccine SSI

Interventions

TdaP vaccine SSIBIOLOGICAL

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)

TdaP vaccine
Td vaccine SSIBIOLOGICAL

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)

Td vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
  • Females if pregnant or breastfeeding or not willing to use contraception during the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

H:S Rigshospitalet

Copenhagen, 2100, Denmark

Location

aCROnordic

Hoersholm, 2970, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 22776216DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Birgit Thierry-Carstensen, M.Sc. Pharm

    Statens Serum Institut

    STUDY DIRECTOR

  • Carsten Heilmann, Professor MD

    H:S Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DK(2)