Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01106092
First received: April 1, 2010
Last updated: December 8, 2011
Last verified: December 2011

April 1, 2010
December 8, 2011
May 2010
September 2010   (final data collection date for primary outcome measure)
  • Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: Prior booster vaccination (At Month 0) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01106092 on ClinicalTrials.gov Archive Site
  • Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of booster response to Bordetella pertussis [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From the booster dose up to study end (From Day 0 to Month 1) ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the study vaccines (on secondary read-out) [ Time Frame: Prior to and one month after booster vaccination ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From the booster dose up to study end ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Haemophilus Influenzae Type b
  • Poliomyelitis
  • Hepatitis B
  • Diphtheria
  • Pertussis
  • Tetanus
  • Biological: GSK2036874A vaccine
    Intramuscular, single dose
  • Biological: Zilbrix™/Hib vaccine
    Intramuscular, single dose
  • Biological: Poliorix™
    Intramuscular, single dose
  • Experimental: Group A
    Subjects will receive formulation 1 of GSK2036874A vaccine.
    Intervention: Biological: GSK2036874A vaccine
  • Experimental: Group B
    Subjects will receive formulation 2 of GSK2036874A vaccine.
    Intervention: Biological: GSK2036874A vaccine
  • Experimental: Group C
    Subjects will receive formulation 3 of GSK2036874A vaccine.
    Intervention: Biological: GSK2036874A vaccine
  • Active Comparator: Control Group
    Subjects will receive Zilbrix™/Hib and Poliorix™.
    Interventions:
    • Biological: Zilbrix™/Hib vaccine
    • Biological: Poliorix™
Quiambao B, Van Der Meeren O, Kolhe D, Gatchalian S. A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers. Hum Vaccin Immunother. 2012 Mar;8(3):347-54. doi: 10.4161/hv.18630. Epub 2012 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
  • Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
  • 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:

  • 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 dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
  • 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.
  • History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of neurologic disorders or seizures.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Administration of immunoglobulins 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 against diphtheria and/or tetanus.
  • Child in care.
  • Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:

    • encephalopathy of unknown aetiology occurring within seven 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.

    • Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
    • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
Both
12 Months to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01106092
113264
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2011

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