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Completed

NCT Number: NCT00383123

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Antioch, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A male or female child age 6 months to < 18 years at the time of the 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 should be enrolled in the study.
  • Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
  • Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine, other than the study 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.
  • 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 enrollment.
  • History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Pregnant or lactating female.
  • Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Treatment and study plan

Fluarix™

Biological

Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.

*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.

Fluzone

Biological

Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.

*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.

Primary outcomes

  1. Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies

    Time frame: 21 or 28 days after last vaccine dose

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

  2. Number of Seroconverted Subjects

    Time frame: 21 or 28 days after last vaccine dose

    Seroconverted subjects are defined as subjects with either a pre-vaccination HI 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.

    Data are presented for all 3 viral strains comprised in the vaccine.

  3. Number of Subjects Reporting Rare Serious Events

    Time frame: Up to 6 months after vaccination

    Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:

    • resulted in death,
    • was life-threatening,
    • required hospitalization or prolongation of existing hospitalization,
    • resulted in disability/incapacity, or
    • was a congenital anomaly/birth defect in the offspring of a study subject.

Secondary outcomes

  1. Number of Seroprotected Subjects

    Time frame: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose

    Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

  2. Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer

    Time frame: 21 or 28 days after last vaccine dose

    Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

  3. Number of Subjects Reporting Solicited Local and General Symptoms

    Time frame: During a 4-day follow-up period after each vaccination

    Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.

    Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.

  4. Number of Subjects Reporting Unsolicited Adverse Events

    Time frame: Within 28 days following vaccination

    An Adverse Event 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.

    Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.

  5. Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)

    Time frame: Up to 6 months after vaccination

    SAE: any untoward medical occurrence that

    • resulted in death,
    • was life-threatening,
    • required hospitalization or prolongation of existing hospitalization,
    • resulted in disability/incapacity, or
    • was a congenital anomaly/birth defect in the offspring of a study subject.

    Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 2, 2006
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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