An open, phase IV, non-randomised, single-centre study with two study groups to assess the immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals' combined reduced antigen content diphtheria-tetanus toxoids andacellular pertussis vaccine (Boostrix), when administered in young adults, 10 years after previous booster vaccination in study 263855/004 (dTpa-004). - DTPA (BOOSTRIX): 040 EXT Y10

• Conditions: Booster vaccination against diphtheria, tetanus and pertussis diseases in adults

• Registration Number: EUCTR2007-003248-31-FI
• Lead Sponsor: GSK Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004 (dTpa-004) study.
•A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/004 (dTpa-004).
•If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series. Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or other barrier method (condom or occlusive cap).
•Written informed consent obtained from the subject.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination. or planned administration during the active study period (up to Visit 2).
•Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004 (dTpa-004).
•History of documented diphtheria, tetanus, or pertussis diseases.
•Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination (no laboratory testing required).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified