Clinical trial NCT01014091: Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza
Keywords: influenza infection
GSK Bio's influenza vaccine GSK2340272A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
timeFrame: At Day 42
measure: Number of Seropositive Subjects for HI Antibodies
timeFrame: At Day 42
measure: Number of Seroconverted Subjects in Terms of HI Antibodies
timeFrame: At Day 42
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Day 42
measure: Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
timeFrame: At Day 42
Secondary outcomes:
measure: Number of Seropositive Subjects for HI Antibodies
timeFrame: At Day 0, Day 21 and Month 7
measure: HI Antibody Titers Against Vaccine H1N1 Antigen
timeFrame: At Day 0, Day 21 and Month 7
measure: Number of Seroconverted Subjects in Terms of HI Antibodies
timeFrame: At Day 21 and Month 7
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Day 0, Day 21 and Month 7
measure: Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
timeFrame: At Day 21 and Month 7
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any Medically-attended Events (MAEs)
timeFrame: During the entire study period (from Month 0 up to Month 12)
measure: Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)
timeFrame: During the entire study period (from Month 0 up to Month 12)
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within the 42-day (Days 0-41) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 to Month 12)
Other outcomes:
Locations:
city: Decin
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Praha 6
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: