Skip to main content
OpenTrials
Completed

NCT Number: NCT01294605

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boostrix™ (dTpa)

Biological

Intramuscular, 3 doses

GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)

Biological

Intramuscular, single dose

Ditanrix™ Adult, TedivaxTM (Td)

Biological

Intramuscular, 2 doses

Primary outcomes

  1. Immunogenicity with respect to components of the study vaccines

    Time frame: One month after the third dose (Month 7)

Secondary outcomes

  1. Immunogenicity with respect to components of the study vaccines

    Time frame: One month after each dose (Months 1, 2 and 7)

  2. Occurrence of solicited local and general symptoms

    Time frame: Within 15 days (day 0 -14) after each vaccine dose.

  3. Occurrence of unsolicited symptoms

    Time frame: Within 31 days (day 0-30) after each vaccine dose.

  4. Occurrence of serious adverse events

    Time frame: Until 31 days (day 0-30) after the last vaccine dose.

  5. Occurrence of large local swelling reported

    Time frame: Within 15 days (day 0-14) after each vaccine dose

  6. Use of concomitant medication taken

    Time frame: Within 31 days (day 0-30) after each vaccine dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Feb 11, 2011
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.