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Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years

Phase 2
18 Years
64 Years
Not Enrolling
Influenza, Influenza Vaccines

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Trial Information

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep

Inclusion Criteria:

- Only subjects who the investigator believes that they can and will comply with the
requirements of the protocol .

- A male or female between, and including, 18 - 64 years of age at the time of

- Written informed consent obtained from the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must have a negative pregnancy test, practice adequate
contraception for 30 days prior to vaccination, and continue such precautions for 2
months after completion of the vaccination series.

Exclusion Criteria:

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

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within three months prior to the first vaccine dose

- Administration of a vaccine not foreseen by the study protocol from 30 days before
vaccination, up to 21 days after vaccination.

- History of hypersensitivity to a previous dose of influenza vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine(s)

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening

- Confirmed influenza infection within a year preceding the study start.

- Administration of an influenza vaccine within a year preceding the study start.

- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study

- Pregnant or lactating female.

- Concurrent participation 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

- Acute disease at the time of enrolment.

- History of chronic alcohol consumption and/or drug abuse.

- Female planning to become pregnant or planning to discontinue contraceptive

- Any condition which, in the opinion of the investigator, prevents the subject from
participating in the study.

- History of administration of experimental/licensed vaccine containing squalene and/or
tocopherol within the last 12 months.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Concentration of Serum Hemagglutination-Inhibition (HI) Antibodies Prior to and 21 Days After Vaccination

Outcome Time Frame:

At Day 0 and 21

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Spain:Agencia Espanola de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

October 2007

Completion Date:

May 2008

Related Keywords:

  • Influenza
  • Influenza Vaccines
  • Influenza
  • Influenza Vaccine
  • Influenza, Human