Immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline Biologicals’ GSK2036874A vaccine in healthy toddlers.

Phase 1

• Conditions: Booster immunisation against poliomyelitis disease; MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-000645-31-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

•A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
•Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR)(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 312
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 immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. 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).
•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).
•History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Hib diseases.
•Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae dis-eases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodefi-ciency.
•Major congenital defects or serious chronic illness.
•History of neurologic disorders or seizures.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including neomycin and polymyxin).
•Administration of immunoglobulins 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.
•Child in care.
•Occurrence of any of the following adverse event after a previous administration of a DTP vaccine:
-encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
-fever >= 40 °C (axillary 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,
-convulsions with or without fever, occurring within 3 days of vaccination.
•Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.

Study & Design

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