Evaluation of GSK Biologicals’ Boostrix Polio in healthy adults, 10 years after a booster vaccination.

• Conditions: Booster immunisation of healthy adults against diphtheria, tetanus, pertussis and poliomyelitis.; MedDRA version: 14.0Level: PTClassification code 10043376Term: TetanusSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10013023Term: DiphtheriaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10036012Term: PoliomyelitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-012219-16-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-22
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Subjects who the investigator believes can and will comply with the requirements of the protocol.
•Male or female subjects who have received a dTpa-IPV, dTpa + IPV or Td-IPV vaccine in study NCT01277705.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study.
–Non-childbearing potential is defined as pre-menarcheal, current tubal ligation, hysterectomy, ovariectomy or post-menopausal.
•Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:
–practices/has practiced adequate contraception for 30 days prior to vaccination, and
–has a negative pregnancy test on the day of vaccination, and
–agrees to continue adequate contraception during the entire booster epoch.
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 300
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 other than the study vaccine within 30 days preceding the booster dose of the study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
•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.
•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.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Td-IPV group.
•History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
•Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
•Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
•Occurrence of any of the following adverse event (AE) after a previous administration of a DTP vaccine:
–Hypersensitivity reaction to any component of the vaccine,
–encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
–fever = 40°C within 48 hours of vaccination not due to another identifiable cause,
–collapse or shock-like state within 48 hours of vaccination,
–convulsions with or without fever, occurring within 3 days of vaccination.
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
•Acute disease and/or fever at the time of enrolment.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.

Study & Design

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