Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

September 14, 2016 updated by: GlaxoSmithKline

Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule

This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Wilrijk, Belgium, 2610
        • GSK Investigational Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 GE
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 CJ
        • GSK Investigational Site
  • Spain
      • Alzira, Spain, 46600
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 8025
        • GSK Investigational Site
      • Centelles, Spain
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Mollet del Vallès, Spain, 08100
        • GSK Investigational Site
      • Vic, Spain, 28500
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
  • A male or female adult >= 40 years of age
  • Written informed consent to be obtained from the subject prior to study entry
  • No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • subject should not be pregnant or plan to become pregnant.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions
  • Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Biological: Boostrix™ (dTpa)
Intramuscular, 3 doses
Experimental: Group B
Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Intramuscular, single dose
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 2 doses
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 3 doses
Active Comparator: Group C
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 2 doses
Biological: Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity with respect to components of the study vaccines
Time Frame: One month after the third dose (Month 7)
One month after the third dose (Month 7)

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity with respect to components of the study vaccines
Time Frame: One month after each dose (Months 1, 2 and 7)
One month after each dose (Months 1, 2 and 7)
Occurrence of solicited local and general symptoms
Time Frame: Within 15 days (day 0 -14) after each vaccine dose.
Within 15 days (day 0 -14) after each vaccine dose.
Occurrence of unsolicited symptoms
Time Frame: Within 31 days (day 0-30) after each vaccine dose.
Within 31 days (day 0-30) after each vaccine dose.
Occurrence of serious adverse events
Time Frame: Until 31 days (day 0-30) after the last vaccine dose.
Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported
Time Frame: Within 15 days (day 0-14) after each vaccine dose
Within 15 days (day 0-14) after each vaccine dose
Use of concomitant medication taken
Time Frame: Within 31 days (day 0-30) after each vaccine dose
Within 31 days (day 0-30) after each vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 263855/034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 263855/034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 263855/034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 263855/034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 263855/034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 263855/034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 263855/034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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