Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00920439
First received: June 12, 2009
Last updated: September 5, 2013
Last verified: September 2013

June 12, 2009
September 5, 2013
June 2009
August 2009   (final data collection date for primary outcome measure)
  • Occurrence of solicited local and general symptoms. [ Time Frame: During the 4-day follow-up period after study vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms. [ Time Frame: During the 31-days follow-up period after the study vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs). [ Time Frame: Following vaccination. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920439 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (Poliorix™) in Toddlers

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Poliomyelitis
Biological: PoliorixTM
Single dose, intramuscular administration.
Experimental: IPV Group
Not Applicable
Intervention: Biological: PoliorixTM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2009
August 2009   (final data collection date for primary outcome measure)

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.

Both
18 Months to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00920439
112683
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP