Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis

Treatments: Biological: PoliorixTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920439

112683

Details and patient eligibility

About

The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.

Enrollment: 26 patients

Sex: All

Ages: 18 to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
• Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
• Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of 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 vaccination
• 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 and/or Hib vaccine(s).
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, 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
• Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
• History of poliomyelitis disease.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

POLIORIX GROUP

Experimental group

Description:

Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix™ vaccine that was administrated into the upper right thigh by intramuscular injection (IM).

Treatment:

Biological: PoliorixTM