Study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ inactivated polio vaccine (Poliorix) in infants.

• Conditions: Primary immunisation of healthy infants in the first year of life against poliomyelitis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-003167-30-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1101

Inclusion Criteria

A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
Born after a gestation period of 36 to 42 weeks inclusive.
Subjects who the investigator believes that their par-ents/Legally Acceptable Representative [(LAR) (s)] can and will comply with the requirements of the protocol.
Written informed consent obtained from the par-ents/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: 1101
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 other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth. 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 since birth or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccines.
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 or intercurrent poliomyelitis disease or vaccination.
History of seizures or progressive neurological disease.
Any confirmed or suspected immunosuppressive or im-munodeficint condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Major congenital defects or serious chronic illness.
Child in care.

Study & Design

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