A phase IV, open, non-randomised, multicentre study to assess the reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus, acellular pertussis and inactivated poliovirus vaccine dTpa-IPV (Boostrix-Polio) when administered in healthy subjects aged 9-13 years, 5 years after previous booster vaccination with dTpa-IPV in the study 711866/001 (dTpa-IPV-001). - DTPA-IPV (Boostrix-IPV): 008 Ext 001 Y5

• Conditions: Booster immunisation against diphtheria, tetanus, pertussis and poliomyelitis diseases in children and adolescents.

• Registration Number: EUCTR2007-003477-94-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-14
• 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 or their parents/guardians 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.
A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001 (dTpa-IPV-001).
Healthy subjects as established by medical history and clinical examination before entering into the study.
Females of childbearing potential (i.e., who have reached menarche) at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®, DepoProvera®, contraceptive skin patch or cervical ring) for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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(s) 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 immunosuppressant 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 vaccination, or planned administration during study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001 (dTpa-IPV-001).
History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine:
hypersensitivity reaction to any component of the vaccine,
encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
fever >=40°C (axillary temperature/oral temperature) within 48 hours of vaccination not due to another identifiable cause,
collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine
convulsions with or without fever, occurring within 3 days of vaccination.
Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C / Axillary temperature < 37.5°C / Tympanic temperature < 37.5°C/ Rectal temperature <38°C.
Pregnant or lactating female.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the incidence of grade 3 local reactions occurring during the 4-day (Day 0 - Day 3) follow-up period after administration of a booster dose of dTpa-IPV vaccine in healthy children and adolescents aged 9 to 13 years, 5 years after a previous booster dose of the same vaccine in the study 711866/001 (dTpa-IPV-001). ;Secondary Objective: To assess the immunogenicity of the dTpa-IPV vaccine in terms of antibody response to all vaccine antigens, one month after booster vaccination, to assess the persistence of antibody response to all vaccine antigens, 5 years after the previous booster dose in the study 711866/001 (dTpa-IPV-001), to evaluate the safety and reactogenicity of the dTpa-IPV vaccine in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs).;Primary end point(s): Occurrence of grade 3 local adverse events (AEs) during the 4-day follow-up period (Day 0-Day 3) after booster vaccination.