Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00764790
First received: October 1, 2008
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.


Condition Intervention Phase
Influenza
Biological: Fluarix
Biological: Fluzone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains [ Time Frame: Day 0 (PRE), Day 28 or Day 56 (POST) ] [ Designated as safety issue: No ]

    GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.

    Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects


  • Number of Subjects Who Seroconverted [ Time Frame: Day 28 or Day 56 ] [ Designated as safety issue: No ]

    Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.

    Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects



Secondary Outcome Measures:
  • Number of Seroprotected Subjects [ Time Frame: Day 0 (PRE), Day 28 or Day 56 (POST) ] [ Designated as safety issue: No ]

    A seroprotected subject is a subject with a serum anti-HA titer

    ≥ 1:40

    Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects


  • Seroconversion Factor [ Time Frame: Day 28 or Day 56 ] [ Designated as safety issue: No ]

    Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).

    Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects


  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.

  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During a 28-day follow-up period after vaccination ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  • Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD) [ Time Frame: During the entire study (Day 0 until Month 6) ] [ Designated as safety issue: No ]

    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

    NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders


  • Number of Subjects Reporting Rare Serious Events [ Time Frame: During the entire study (Day 0 until Month 6) ] [ Designated as safety issue: No ]
    Rare serious events have an occurrence rate of 1/300 (0.3%).


Enrollment: 3317
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluarix Dose A Group

Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Biological: Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Experimental: Fluarix Dose B Group

Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Biological: Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Active Comparator: Fluzone Group

Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Biological: Fluzone
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
  • Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
  • History of hypersensitivity to any vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine.
  • 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 an influenza vaccine outside of this study, during current (2008-09) flu season.
  • Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764790

  Show 65 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00764790     History of Changes
Other Study ID Numbers: 111751
Study First Received: October 1, 2008
Results First Received: February 25, 2010
Last Updated: October 11, 2012
Health Authority: Taiwan: Department of Health
Thailand: Ministry of Public Health
Hong Kong: Department of Health
Mexico: Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014