Study to evaluate immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ Inactivated Polio Vaccine (Poliorix) in healthy Chinese toddlers.

• Conditions: Booster immunisation of healthy children in the second year of life against poliomyelitis.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004513-14-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-20
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 957

Inclusion Criteria

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
Subjects who received the complete three-dose primary vaccination course in study IPV-018.
Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1.
Written informed consent obtained from the par-ent(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: 957
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

Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1. For corticosteroids, this will mean prednisone > 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 or planned administration during the 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.
Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study IPV-018.
History of seizures or progressive neurological disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature > 37.0°C on oral, axillary or tympanic setting and > 37. 5°C on rectal setting. The preferred route for recording tempera-ture in this study will be axillary.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

Study & Design

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