Clinical trial NCT00309647: Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
Official title: A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: prophylaxis of pandemic influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.


Eligibility criteria: Inclusion criteria:

* A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
* 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.

Exclusion criteria:

* Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
* Administration of an influenza vaccine other than the study vaccines during the entire study period.
* 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 study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* 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.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three 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.

Primary outcomes:
measure: To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
timeFrame: At Days 0, 21, 42 and 180
measure: To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
timeFrame: At days 21, 42 and 180
measure: Occurrence of solicited local and general adverse events
timeFrame: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
measure: Occurrence of unsolicited adverse events
timeFrame: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
measure: Occurrence of serious adverse events
timeFrame: During the entire study (Days 0 to 180)
Secondary outcomes:
measure: To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
timeFrame: At Days 0, 21, 42 and 180
measure: To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
timeFrame: At days 0, 21, 42 and 180
measure: To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
timeFrame: At Days 21, 42 and 180
Other outcomes:
Locations:
city: Finsterwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Tostedt
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freiberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geringswalde
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Elmshorn
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: