Last updated: 11/07/2018 01:53:53

Evaluate safety & immunogenicity of a pandemic influenza vaccine (GSK1562902A) in children

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GSK study ID
107066
See study documents
Clinicaltrials.gov ID
NCT00502593
See results summary
EudraCT ID
2006-001168-22
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A phase II, randomized, open, controlled study to evaluate the safety and immunogenicity of different formulations of a pandemic influenza vaccine candidate (split virus formulation adjuvanted with AS03) given following a two-administration schedule (21 days apart) in children between 3 and 9 years of age.
Trial description: The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Day 0

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Day 21

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Day 42

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 6

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 12

Titers for serum Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 24

Number of seroconverted subjects against 2 strains of influenza disease

Timeframe: At Day 21

Number of seroconverted subjects against 2 strains of influenza disease

Timeframe: At Day 42

Number of seroconverted subjects against 2 strains of influenza disease

Timeframe: At Month 6

Number of seroconverted subjects against 2 strains of influenza disease

Timeframe: At Month 12

Number of seroconverted subjects against 2 strains of influenza disease

Timeframe: At Month 24

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Day 21

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Day 42

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 6

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 12

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 2 strains of influenza disease

Timeframe: At Month 24

Number of seroprotected subjects against the 2 strains of influenza disease

Timeframe: At Day 0

Number of seroprotected subjects against the 2 strains of influenza disease

Timeframe: At Day 21

Number of seroprotected subjects against the 2 strains of influenza disease

Timeframe: At Day 42

Number of seroprotected subjects against the 2 strains of influenza disease

Timeframe: At Month 6

Number of seroprotected subjects against the 2 strains of influenza disease

Timeframe: At Month 12

Number of seroprotected subjects against the 2 strains of influenza disease

Timeframe: At Month 24

Number of subjects with any, Grade 3 and related solicited local symptoms

Timeframe: During the 7 day follow-up period after each vaccination

Number of subjects with any, Grade 3 and related solicited local symptoms

Timeframe: During the 7-day follow-up period after each vaccination

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 7-day (Days 0-6) follow-up period after any vaccination

Number of subjects with any, Grade 3 and related solicited local symptoms

Timeframe: During the 7-day follow-up period after each vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study (Day 0 to Month 24)

Number of subjects with any, Grade 3 and related unsolicited adverse events

Timeframe: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination

Number of subjects with changed status as regards to the biochemical parameter alanine aminotransferase (ALT) for subjects in study Phase A

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter aspartate aminotransferase (AST) in study Phase A

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter blood urea nitrogen (BUN) in study Phase A

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter creatine phosphokinase (CPK) in study Phase A

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter blood creatinine (CREA) in study Phase A

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter lactate dehydrogenase (LDH) in study Phase A

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter alanine aminotransferase (ALT) for subjects in study Phase B

Timeframe: At Days 21 and 42 and Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter aspartate aminotransferase (AST) in study Phase B

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter blood urea nitrogen (BUN) in study Phase B

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter creatine phosphokinase (CPK) in study Phase B

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter blood creatinine (CREA) in study Phase B

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter lactate dehydrogenase (LDH) in study Phase B

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter alanine aminotransferase (ALT) for subjects in study Phase C

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter aspartate aminotransferase (AST) in study Phase C

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter blood urea nitrogen (BUN) in study Phase C

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status as regards to the biochemical parameter blood creatinine (CREA) in study Phase C

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status with regards to creatine phosphokinase (CPK) in study Phase C

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with changed status with regards to lactate dehydrogenase (LDH) in study Phase C

Timeframe: At Days 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with respect to alanine aminotransferase (ALT) in study Phase A

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with respect to aspartate aminotransferase (AST) in study Phase A

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to blood urea nitrogen (BUN) in study Phase A

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to creatinine (CREA) in study Phase A

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to creatine phosphokinase (CPK) in study Phase A

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to lactate dehydrogenase (LDH) in study Phase A

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with respect to alanine aminotransferase (ALT) in study Phase B

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to aspartate aminotransferase (AST) in study Phase B

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to creatinine (CREA) in study Phase B

Timeframe: At Days 0, 21 and 42 and at Month 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to lactate dehydrogenase (LDH) in study Phase B

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to blood urea nitrogen (BUN) in study Phase B

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to blood urea nitrogen (BUN) in study Phase C

Timeframe: At Days 0, 21 and 42 and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with respect to alanine aminotransferase (ALT) in study Phase C

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to creatine phosphokinase (CPK) in study Phase B

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with respect to aspartate aminotransferase (AST) in study Phase C

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to creatine phosphokinase (CPK) in study Phase C

Timeframe: At Days 0, 21, and 42, and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to creatinine (CREA) in study Phase C

Timeframe: At Days 0, 21 and 42 and at Months 6, 12 and 24

Number of subjects with normal and abnormal biochemical parameters assessed with regards to lactate dehydrogenase (LDH) in study Phase C

Timeframe: At Days 0, 21 and 42 and at Months 6, 12 and 24

Secondary outcomes:

Titers for serum neutralizing antibodies against 1 strain of influenza disease

Timeframe: At Days 0, 21 and 42

Titers for serum neutralizing antibodies against 1 strain of influenza disease

Timeframe: At Days 0, 21 and 42

Titers for serum neutralizing antibodies against 1 strain of influenza disease

Timeframe: At Days 0, 21 and 42

Number of seroconverted subjects against one strain of influenza disease with respect to serum neutralizing antibodies

Timeframe: At Days 21 and 42

Number of seroconverted subjects against one strain of influenza disease with respect to serum neutralizing antibodies

Timeframe: At Days 21 and 42

Number of seroconverted subjects against one strain of influenza disease with respect to serum neutralizing antibodies

Timeframe: At Days 21 and 42

Titers for serum neutralizing antibodies against 2 strains of influenza disease

Timeframe: At Months 6, 12 and 24

Number of seroconverted subjects against 2 strains of influenza disease as regards to neutralizing antibody response

Timeframe: At Months 6, 12 and 24.

Number of subjects with adverse events of specific interest (AESIs)

Timeframe: Throughout the entire study period, from Day 0 to Month 24

Interventions:
  • Biological/vaccine: Pandemic Influenza Vaccine (GSK1562902A)
  • Biological/vaccine: Fluarix™
    • Enrollment:
    138
    Primary completion date:
    2009-04-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Díez-Domingo J et al. (2010) Immunogenicity and safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: A phase II, randomized, open, controlled study. Pediatr Infect Dis J. 29(6): e35–e46.
    Díez-Domingo J et al. (2015) Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: Follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 9(2):68-77.
    Medical condition
    Influenza
    Product
    GSK1562902A, GSK2321141A, SB218352
    Collaborators
    Not applicable
    Study date(s)
    July 2007 to December 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    3 - 9 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion Criteria:

      • Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
      • Children aged between and including 3 and 9 years of age at the time of first vaccination.
      • Written informed consent obtained from the parent(s) or guardian of the subject.
      • Healthy children as established by medical history and clinical examination before entering the study.
      • Subjects who are likely to reside in the vicinity of the study center for the duration of the study. Exclusion criteria:
      • Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
      • Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
      • Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
      • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
      • Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
      • 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 used in this study.
      • History of any neurological disorders or seizures.
      • Acute disease at the time of enrolment.
      • 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    L'Eliana, Valencia, Spain, 46183
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Valencia, Spain, 46008
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Paiporta, Valencia, Spain, 46200
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Valencia, Spain, 46024
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Blanes (Girona), Spain, 17300
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Valencia, Spain, 46011
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 7 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-04-12
    Actual study completion date
    2009-04-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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