Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323647
First received: March 24, 2011
Last updated: July 26, 2012
Last verified: February 2012

March 24, 2011
July 26, 2012
April 2011
September 2011   (final data collection date for primary outcome measure)
  • Immunogenicity with respect to components of the study vaccine [ Time Frame: Before vaccination (Day 0) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine [ Time Frame: One month after booster vaccination in Group A ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01323647 on ClinicalTrials.gov Archive Site
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination in Group A ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period after IPV booster vaccination in Group A ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From Day 0 up to 30 days following vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Poliomyelitis
  • Biological: PoliorixTM
    Single dose, intramuscular administration
  • Biological: Infanrix+Hib
    Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
  • Experimental: Group A
    Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
    Interventions:
    • Biological: PoliorixTM
    • Biological: Infanrix+Hib
  • Active Comparator: Group B
    Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
    Intervention: Biological: Infanrix+Hib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
957
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
  • Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
  • Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) 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 NCT01021293.
  • 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.
Both
18 Months to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01323647
114306
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

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