Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01245049
First received: November 18, 2010
Last updated: October 17, 2013
Last verified: August 2013

November 18, 2010
October 17, 2013
April 2011
April 2012   (final data collection date for primary outcome measure)
Immunogenicity with respect to the components of the study vaccines. [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01245049 on ClinicalTrials.gov Archive Site
  • Immunogenicity with respect to the components of the study vaccines. [ Time Frame: Prior to and one month after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Solicited local and general symptoms. [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Unsolicited adverse events. [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of Serious adverse events. [ Time Frame: From the booster dose up to study end (Day 0 to Month 1). ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children
Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Acellular Pertussis
  • Poliomyelitis
  • Tetanus
  • Diphtheria
  • Biological: Boostrix PolioTM
    Single dose, intramuscular administration.
  • Biological: RepevaxTM
    Single dose, intramuscular administration.
  • Biological: PriorixTM
    Single dose, intramuscular or subcutaneous administration.
  • Experimental: Group A
    Subjects receiving one booster dose each of Boostrix Polio and Priorix vaccines.
    Interventions:
    • Biological: Boostrix PolioTM
    • Biological: PriorixTM
  • Active Comparator: Group B
    Subjects receiving one booster dose each of Repevax and Priorix vaccines.
    Interventions:
    • Biological: RepevaxTM
    • Biological: PriorixTM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
387
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
  • Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).
  • Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
  • 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, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.
  • 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 diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.
  • Previous measles, mumps and/or rubella second dose vaccination.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.
  • Known exposure to measles, mumps and/or rubella within 30 days prior to study start.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.
  • Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:

    • Hypersensitivity reaction to any component of the vaccine;
    • Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
    • Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;
    • Collapse or shock-like state within 48 hours of vaccination;
    • Convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.
Both
3 Years to 4 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01245049
111763
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

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