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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

October 1, 2008
October 11, 2012
October 2008
March 2009   (final data collection date for primary outcome measure)
  • 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

  • Humoral immune response in terms of serum anti-haemagglutinin (HA) antibodies against each of the vaccine influenza virus strains, in each group. [ Time Frame: Day 0, Day 28, Day 56 ]
  • Geometric mean titres (GMTs) of HI antibody titres [ Time Frame: Day 0, Day 28, Day 56 ]
  • Seroconversion Rate (SCR) [ Time Frame: Day 28, Day 56 ]
Complete list of historical versions of study NCT00764790 on ClinicalTrials.gov Archive Site
  • 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%).
  • Humoral immune response in terms of serum anti-haemagglutinin (HA) antibodies against each of the vaccine influenza virus strains, in each group. [ Time Frame: Day 0, Day 28, Day 56 ]
  • Seroprotection Rate (SPR) [ Time Frame: Day 0, Day 28, Day 56 ]
  • Seroconversion Factor (SCF) [ Time Frame: Day 28, Day 56 ]
  • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4-day follow-up period after vaccination ]
  • Percentage, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: During a 28-day follow-up period after vaccination ]
  • Occurrence of serious adverse events and new onset chronic illnesses [ Time Frame: During the entire study ]
  • Occurrence of rare serious adverse events [ Time Frame: During the entire study ]
Not Provided
Not Provided
 
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Fluarix
    One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
  • Biological: Fluzone
    One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
  • 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.

    Intervention: Biological: Fluarix
  • 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.

    Intervention: Biological: Fluarix
  • 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.

    Intervention: Biological: Fluzone
Pavia-Ruz N, Angel Rodriguez Weber M, Lau YL, Nelson EA, Kerdpanich A, Huang LM, Silas P, Qaqundah P, Blatter M, Jeanfreau R, Lei P, Jain V, El Idrissi M, Feng Y, Innis B, Peeters M, Devaster JM. A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 2013 Sep;9(9):1978-88. doi: 10.4161/hv.25363. Epub 2013 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3317
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Hong Kong,   Mexico,   Taiwan,   Thailand
 
NCT00764790
111751
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP