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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

NCT01033877 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2013-01-21

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Birgit Thierry-Carstensen, M.Sc. Pharm · Statens Serum Institut

  • Carsten Heilmann, Professor MD · H:S Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033877 on ClinicalTrials.gov