InfluenzaPhase 2NCT00545701
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
A Phase 2 study testing A/H5N1 inactivated, split-virion influenza virus in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Australia.
Trial summary
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives: To describe the immune response 21 days after each vaccination. To describe the safety profiles following each vaccination. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviridae Infections
- What is being tested?
- A/H5N1 inactivated, split-virion influenza virus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 60 years on day of inclusion.
- Informed Consent Form signed.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman, inability to bear a child or negative urine pregnancy test.
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.
Who cannot join
- Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
- Breast-feeding.
- Previous vaccination with an avian flu vaccine.
- Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
- Planned participation in another clinical trial during the present trial period.
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- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
- Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Trial locations and contacts
2 sites in 1 country.
About this study
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.
Objectives:
- To describe the immune response 21 days after each vaccination.
- To describe the safety profiles following each vaccination.
- Conditions
- Influenza, Orthomyxoviridae Infections
- Being tested
- A/H5N1 inactivated, split-virion influenza virus
- Keywords
- Influenza, A/H5N1 strain, Orthomyxoviridae Infections, Influenza Pandemics
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A/H5N1 inactivated, split-virion influenza virusBiological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: A/H5N1 inactivated, split-virion influenza virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
Measured: Day 42 post-vaccination 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545701
- Sponsor's protocol ID
- GPA11
- Status last verified
- Jan 2014
- First submitted
- 15 Oct 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
- ClinicalTrials.gov ID
- NCT00545701
- Acronym / sponsor ID
- GPA11
- Conditions
- Influenza, Orthomyxoviridae Infections
- Keywords
- Influenza, A/H5N1 strain, Orthomyxoviridae Infections, Influenza Pandemics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.
Objectives:
- To describe the immune response 21 days after each vaccination.
- To describe the safety profiles following each vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza virus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 60 years on day of inclusion.
- Informed Consent Form signed.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman, inability to bear a child or negative urine pregnancy test.
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.
Key exclusion criteria (14 listed)
- Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
- Breast-feeding.
- Previous vaccination with an avian flu vaccine.
- Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A/H5N1 inactivated, split-virion influenza virus0.5 mL, Intramuscular | Biological | 1 |
Primary outcome
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
Time frame: Day 42 post-vaccination 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Sanofi Pasteur Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A/H5N1 inactivated, split-virion influenza virus in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine (time frame: Day 42 post-vaccination 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.