Last updated: 11/03/2018 09:01:04
Study to evaluate the safety and immunogenicity of pandemic monovalent (H5N1) influenza vaccines (whole virus formulation) in adults 18 and 60 years of age
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
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
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
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
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
Occurrence of serious adverse events
Timeframe: During the entire study (Days 0 to 180)
Secondary outcomes:
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
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
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
Interventions:
Biological/vaccine: Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine
Biological/vaccine: Influenza Monovalent Whole virus (H5N1)
Enrollment:
400
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1119711A
Collaborators
Not applicable
Study date(s)
March 2006 to November 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
Status
Study Complete
Location
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Location
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-16-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 106378 can be found on the GSK Clinical Study Register
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