Last updated: 11/07/2018 05:49:42

Immunogenicity and safety study of a GlaxoSmithKline Biologicals’ candidate influenza vaccine in healthy children

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GSK study ID
113237
See study documents
Clinicaltrials.gov ID
NCT00985790
See results summary
EudraCT ID
2012-002587-27
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: Immunogenicity and safety study of a GlaxoSmithKline Biologicals’ candidate influenza vaccine GSK2321138A in healthy children
Trial description: The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against the 3 Fluarix vaccine strains.

Timeframe: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]

Secondary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Timeframe: At Days 0 and 28.

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Timeframe: At Days 0, 28 and Day 56

Number of seropositive subjects against 4 strains of influenza disease.

Timeframe: At Days 0 and 28

Number of seropositive subjects against 4 strains of influenza disease.

Timeframe: At Days 0, 28 and 56

Number of seroconverted subjects against 4 strains of influenza disease.

Timeframe: At Day 28

Number of seroconverted subjects against 4 strains of influenza disease.

Timeframe: At Days 28 and 56

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Timeframe: At Day 28

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Timeframe: At Days 28 and 56

Number of seroprotected subjects against 4 strains of influenza disease.

Timeframe: At Days 0 and 28

Number of seroprotected subjects against 4 strains of influenza disease.

Timeframe: At Days 0, 28 and 56

Number of subjects with any and grade 3 solicited local symptoms.

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

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

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

Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).

Timeframe: During the 28-day follow-up period (Days 0 to 27) after vaccination

Number of subjects with any and related serious adverse events (SAEs).

Timeframe: From Day 0 to Day 180 (study conclusion)

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

Timeframe: From Day 0 to Day 180 (study conclusion)

Interventions:
  • Biological/vaccine: Influenza vaccine GSK2321138A
  • Biological/vaccine: Fluarix™
    • Enrollment:
    599
    Primary completion date:
    2010-21-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Rodriguez-Weber MA et al. (2014) Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. Pediatr Infect Dis J. 33(12):1262-1269.
    Medical condition
    Influenza
    Product
    GSK2321138A, SB218352
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to May 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 47 months
    Accepts healthy volunteers
    Yes
    • For all subjects:
    • Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
    • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • History of hypersensitivity to any vaccine.
    Inclusion and exclusion criteria
    Inclusion criteria:

      For all subjects:

      • Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
      • Written informed consent obtained from the subject/from the LAR(s). For unprimed subjects:
      • A male or female child aged 18 to 47 months at the time of the first vaccination.
      • Children who did not have influenza vaccine in a previous season. For primed subjects from study NCT00764790:
      • Children who received Fluarix™ in the 111751 study NCT00764790.
    Exclusion criteria:

      Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

      • History of hypersensitivity to any vaccine.
      • History of allergy or reactions likely to be exacerbated by any component of the vaccine.
      • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
      • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
      • Acute disease at the time of enrolment.
      • History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
      • Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
      • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
      • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
      • Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
      • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ecatepec de Morelos, Estado de México, Mexico, 55075
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mexico city, Mexico, 04530
    Status
    Study Complete
    Contact us

    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
    2010-21-05
    Actual study completion date
    2010-21-05

    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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