Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01014091
First received: November 12, 2009
Last updated: November 1, 2012
Last verified: May 2011

November 12, 2009
November 1, 2012
December 2009
January 2011   (final data collection date for primary outcome measure)
Humoral immune response in terms of haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01014091 on ClinicalTrials.gov Archive Site
  • Humoral immune response in terms of haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 0, Day 21 and Month 7 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralising antibodies (in a subset of subjects) [ Time Frame: At Day 0, Day 21, Day 42 and Month 7 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During a 7-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During a 21-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events, adverse events of specific interest/potential immune mediated disease, medically attended event [ Time Frame: During the entire study period (from day 0 to month 12) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza Infection
  • Biological: GSK pandemic vaccine GSK2340272A
    2 intramuscular injections
  • Biological: GSK pandemic vaccine GSK2340269A
    2 intramuscular injections
  • Experimental: Group A
    Subjects receiving GSK23440272A vaccine (standard dose)
    Intervention: Biological: GSK pandemic vaccine GSK2340272A
  • Experimental: Group B
    Subjects receiving GSK23440272A vaccine (alternative dose)
    Intervention: Biological: GSK pandemic vaccine GSK2340272A
  • Experimental: Group C
    Subjects receiving GSK2340269A vaccine
    Intervention: Biological: GSK pandemic vaccine GSK2340269A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
January 2011
January 2011   (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.
  • Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
  • Written informed consent obtained from the parent(s) or LAR(s) of the subject.
  • Healthy children, as established by medical history and clinical examination when entering the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Have received any seasonal flu vaccine since last year.
  • Previous administration of any H1N1 A/California-like vaccine
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • 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°C on rectal setting.
    • Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
  • Child in Care.
Both
3 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01014091
113810
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2011

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