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An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster

NCT00870350 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2010-06-07

No results posted yet for this study

Summary

Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups, will receive Td5ap or Td1aP as a single injection. We will then describe the immune response and safety profile of the combined vaccine booster.

Conditions

  • Tetanus
  • Diphtheria
  • Pertussis

Interventions

BIOLOGICAL

Td5ap

Intramuscular injection of 0.5 mL Td5ap (COVAXiS) on day 1.

BIOLOGICAL

Td1aP

Intramuscular injection of 0.5 mL Td1aP (diTekiBooster) on day 1.

Sponsors & Collaborators

  • MCM Vaccines B.V.

    collaborator INDUSTRY

  • Statens Serum Institut

    collaborator OTHER

  • Swedish Institute for Infectious Disease Control

    lead OTHER

Principal Investigators

  • Leif Gothefors, Prof. em. · Swedish Institute for Infectious Disease Control

  • Eva Netterlid · Swedish Institute for Infectious Disease Control

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-10-31
Completion
2010-06-30

Countries

  • Sweden

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 NCT00870350 on ClinicalTrials.gov