InfluenzaPhase 2NCT00415129
Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
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 4 sites in 2 countries.
Trial summary
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2006to Mar 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged over 18 years on the 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 and at least 4 weeks after to 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
- 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
Show all 14Show fewer
- 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 within the past 3 months
- Any vaccination within 4 weeks prior to the first trial vaccination
- Vaccination planned within 4 weeks after 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
4 sites in 2 countries.
4 sites in 2 countries
About this study
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.
- Conditions
- Influenza, Orthomyxoviridae Infections
- Being tested
- A/H5N1 inactivated, split-virion influenza virus
- Keywords
- Influenza, Orthomyxoviridae Infections, Influenza Pandemics, A/H5N1 strain
- 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
0.5mL, Intramuscular
A/H5N1 inactivated, split-virion influenza virusBiological
0.5mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Vaccine with adjuvant Receives: Biological: A/H5N1 inactivated, split-virion influenza virus |
| Study Group 2 | Experimental | Vaccine without adjuvant 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 safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
Measured: 21 Days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 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
- NCT00415129
- Sponsor's protocol ID
- GPA02
- Status last verified
- Jan 2014
- First submitted
- 21 Dec 2006
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lazarus R, Kelly S, Snape MD, Vandermeulen C, Voysey M, Hoppenbrouwers K, Hens A, Van Damme P, Pepin S, Leroux-Roels I, Leroux-Roels G, Pollard AJ. Antibody Persistence and Booster Responses to Split-Virion H5N1 Avian Influenza Vaccine in Young and Elderly Adults. PLoS One. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384. eCollection 2016.
PubMed 27814377Leroux-Roels I, Van der Wielen M, Kafeja F, Vandermeulen C, Lazarus R, Snape MD, John T, Carre C, Nougarede N, Pepin S, Leroux-Roels G, Hoppenbrouwers K, Pollard AJ, Van Damme P. Humoral and cellular immune responses to split-virion H5N1 influenza vaccine in young and elderly adults. Vaccine. 2009 Nov 16;27(49):6918-25. doi: 10.1016/j.vaccine.2009.08.110. Epub 2009 Sep 15.
PubMed 19761837
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
- Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
- ClinicalTrials.gov ID
- NCT00415129
- Acronym / sponsor ID
- GPA02
- Conditions
- Influenza, Orthomyxoviridae Infections
- Keywords
- Influenza, Orthomyxoviridae Infections, Influenza Pandemics, A/H5N1 strain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Dec 2006 (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.
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza virusVaccine with adjuvant |
| Study Group 2 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza virusVaccine without adjuvant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18 years on the 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 and at least 4 weeks after to 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
- 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 virus0.5mL, Intramuscular | Biological | Study Group 1 |
| A/H5N1 inactivated, split-virion influenza virus0.5mL, Intramuscular | Biological | Study Group 2 |
Primary outcome
To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
Time frame: 21 Days post-vaccination
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.
- Derived from this study: PubMed 27814377Lazarus R, Kelly S, Snape MD, Vandermeulen C, Voysey M, Hoppenbrouwers K, Hens A, Van Damme P, Pepin S, Leroux-Roels I, Leroux-Roels G, Pollard AJ. Antibody Persistence and Booster Responses to Split-Virion H5N1 Avian Influenza Vaccine in Young and Elderly Adults. PLoS One. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384. eCollection 2016.
- Derived from this study: PubMed 19761837Leroux-Roels I, Van der Wielen M, Kafeja F, Vandermeulen C, Lazarus R, Snape MD, John T, Carre C, Nougarede N, Pepin S, Leroux-Roels G, Hoppenbrouwers K, Pollard AJ, Van Damme P. Humoral and cellular immune responses to split-virion H5N1 influenza vaccine in young and elderly adults. Vaccine. 2009 Nov 16;27(49):6918-25. doi: 10.1016/j.vaccine.2009.08.110. Epub 2009 Sep 15.
- 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
4 sites in 2 countries: 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 4 sites in 2 countries.
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 4 sites in Belgium, United Kingdom. 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 safety of an A/H5N1 inactivated, split-virion influenza virus vaccine (time frame: 21 Days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00415129, which also lists 2 linked publications.
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.