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OpenTrials
Completed

NCT Number: NCT00764790

Immunogenicity and Safety of GSK Biologicals' Influenza 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.

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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–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Pokfulam, Hong Kong

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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 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.

Treatment and study plan

Fluarix

Biological

One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.

Fluzone

Biological

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

Primary outcomes

  1. 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)

    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

  2. Number of Subjects Who Seroconverted

    Time frame: Day 28 or Day 56

    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 outcomes

  1. Number of Seroprotected Subjects

    Time frame: Day 0 (PRE), Day 28 or Day 56 (POST)

    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

  2. Seroconversion Factor

    Time frame: Day 28 or Day 56

    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

  3. Number of Subjects Reporting Solicited Local Symptoms

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

    Solicited local symptoms assessed include pain, redness and swelling.

  4. Number of Subjects Reporting Solicited General Symptoms

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

    Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.

  5. Number of Subjects Reporting Unsolicited Adverse Events (AE)

    Time frame: During a 28-day follow-up period after vaccination

    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

  6. 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)

    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

  7. Number of Subjects Reporting Rare Serious Events

    Time frame: During the entire study (Day 0 until Month 6)

    Rare serious events have an occurrence rate of 1/300 (0.3%).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 2, 2008
Registry last updated
Jul 31, 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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