Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00319098
• Date of registration: 26/04/2006
• Primary sponsor: GlaxoSmithKline
• Public title: Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
• Scientific title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation ) in Adults Aged 18 Years and Older
• Date of first enrolment: May 2006
• Target sample size: 5075
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00319098
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Estonia, France, Germany, Netherlands, Russian Federation, Spain, Sweden

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- A male or female aged 18 years or above 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, for 30 days
prior to first vaccination, have a negative pregnancy test and must agree to continue
such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

- Administration of other 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 up to 30 days after
the second vaccination.

- Administration of interpandemic influenza vaccine between Day 0 and Day 51of the
study. Those study participants belonging to risk groups eligible to receive the
annual interpandemic influenza vaccine (in accordance with local regulations) can
receive the annual vaccination after day 51 and before the end of the study on Day
180.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within 6 months prior to the first administration of the study
vaccine.

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

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

- History of hypersensitivity to vaccines.

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

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

- Major congenital defects or serious chronic disease including any medically
significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or
metabolic disorder, as determined by medical history and physical examination.
(Subjects suffering from seasonal allergies or asthma under inhalative treatment can
be included).

- 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 study 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Adjuvanted pandemic influenza candidate vaccine

Biological: Fluarix

Biological: Placebo

Primary Outcome(s)

Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits [Time Frame: During the entire study period in each group.]

Occurrence of new onset chronic diseases [Time Frame: During the entire period in each group]

Occurrence of serious adverse events [Time Frame: During the entire study period]

Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [Time Frame: During a 7 day follow-up period after each dose of vaccine and overall.]

Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [Time Frame: During a 21-day follow-up period after the first vaccination and during a 30-day follow-up period after the second vaccination]

Secondary Outcome(s)

For the humoral immune response in terms of both anti-HA antibodies and neutralising antibodies• Seroconversion factors [Time Frame: At days 21, 42 and 180]

For the humoral immune response in terms of both anti-HA antibodies and neutralising antibodies• Seroconversion rates (SC) [Time Frame: At days 21, 42 and 180.]

For the humoral immune response in terms of both anti-HA antibodies and neutralising antibodies• Seroprotection rates [Time Frame: At days 0, 21, 42 and 180]

For the humoral immune response in terms of both anti-haemagglutinin (HA) antibodies and neutralising antibodies• Geometric mean titers (GMTs) of H5N1 antibody titers [Time Frame: At days 0, 21, 42 and 180]

Secondary ID(s)

107064

107217

Source(s) of Monetary Support

Please refer to primary and secondary sponsors