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
  Purpose

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.


Condition Intervention Phase
Influenza Infection
Biological: GSK pandemic vaccine GSK2340272A
Biological: GSK pandemic vaccine GSK2340269A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects receiving GSK23440272A vaccine (standard dose)
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: Group B
Subjects receiving GSK23440272A vaccine (alternative dose)
Biological: GSK pandemic vaccine GSK2340272A
2 intramuscular injections
Experimental: Group C
Subjects receiving GSK2340269A vaccine
Biological: GSK pandemic vaccine GSK2340269A
2 intramuscular injections

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014091

Locations
Czech Republic
GSK Investigational Site
Decin, Czech Republic, 405 01
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Praha 6, Czech Republic, 1600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01014091     History of Changes
Other Study ID Numbers: 113810
Study First Received: November 12, 2009
Last Updated: November 1, 2012
Health Authority: Czech: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Bio's influenza vaccine GSK2340272A

Additional relevant MeSH terms:
Infection
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014