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Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years

Phase 3
18 Years
60 Years
Not Enrolling

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Trial Information

Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years

The protocol posting has been updated to reflect changes due to an amendment to the protocol
(addition of an exclusion criterion). The Protocol Posting has been updated in order to
comply with the FDA Amendment Act, Sep 2007.

Inclusion Criteria:

- 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 and 60 years of age at the time of the
first vaccination.

- 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 of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for two
months after completion of the vaccination series.

Exclusion Criteria:

- Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrolment in this study.

- Planned administration of a vaccine not foreseen by the study protocol during the
following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4
weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or
Month 6 + 51 days for the control groups).

- Previous vaccination with a pandemic candidate vaccine or a vaccine containing the
same adjuvant as the study vaccine.

- Previous proven contact with H5N1 wild type virus (i.e. contact with an individual
with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry)
which died as a result of H5N1 infection).

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first administration of the
candidate vaccines.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, or
autoimmune diseases such as Guillain Barre Syndrome, based on medical history and
physical examination (no laboratory testing required).

- History of hypersensitivity to vaccines.

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

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

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

- Serious chronic disease including any medically significant chronic pulmonary,
cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined
by medical history and physical examination.

- Acute disease at the time of enrolment.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first administration of the candidate vaccine or during the study.

- Lactating women.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Humoral response in terms of serum anti-haemagglutinin (HA) antibody geometric mean titres (GMT).

Outcome Time Frame:

Day 42

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Singapore: Health Sciences Authority

Study ID:




Start Date:

March 2007

Completion Date:

June 2008

Related Keywords:

  • Influenza
  • Influenza
  • Influenza Vaccine
  • Influenza, Human