Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
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
1 other identifier
interventional
400
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2006
Shorter than P25 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2006
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2006
CompletedMay 8, 2017
May 1, 2017
7 months
March 31, 2006
May 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Geometric mean titers (GMTs) of serum antibodies
At Days 0, 21, 42 and 180
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
At days 21, 42 and 180
Occurrence of solicited local and general adverse events
During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
Occurrence of unsolicited adverse events
During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Occurrence of serious adverse events
During the entire study (Days 0 to 180)
Secondary Outcomes (3)
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
At Days 0, 21, 42 and 180
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
At days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
At Days 21, 42 and 180
Study Arms (8)
H5N1 Formulation 1 Group
EXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
H5N1 Formulation 2 Group
EXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
H5N1 Formulation 3 Group
EXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval
H5N1 Formulation 4 Group
EXPERIMENTALSubjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
H5N1 Formulation 5 Group
ACTIVE COMPARATORSubjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
H5N1 Formulation 6 Group
ACTIVE COMPARATORSubjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
H5N1 Formulation 7 Group
ACTIVE COMPARATORSubjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
H5N1 Formulation 8 Group
ACTIVE COMPARATORSubjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval
Interventions
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (9)
GSK Investigational Site
Finsterwalde, Brandenburg, 03238, Germany
GSK Investigational Site
Tostedt, Lower Saxony, 21255, Germany
GSK Investigational Site
Dresden, Saxony, 01129, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Freiberg, Saxony, 09599, Germany
GSK Investigational Site
Geringswalde, Saxony, 09326, Germany
GSK Investigational Site
Schmiedeberg, Saxony, 01762, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795, Germany
GSK Investigational Site
Elmshorn, Schleswig-Holstein, 25335, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
March 29, 2006
Primary Completion
November 1, 2006
Study Completion
November 16, 2006
Last Updated
May 8, 2017
Record last verified: 2017-05