Pandemic InfluenzaPhase 1NCT00457509
Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
A Phase 1 study testing A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant and A/H5N1 inactivated, split-virion influenza vaccine in people with Pandemic Influenza and Influenza A Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 3 sites in Belgium.
Trial summary
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pandemic Influenza, Influenza A Virus Infection, Orthomyxoviridae Infections
- What is being tested?
- A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant and A/H5N1 inactivated, split-virion influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 3 sitesBelgium
- Study dates
- Jan 2007to Sep 2010
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 40 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.
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
- Vaccination with an influenza vaccine during the past 6 months
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following any trial vaccination
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- Breast-feeding.
- For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
- Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Blood or blood-derived products received in the past 3 months.
- Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
- Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
Trial locations and contacts
3 sites in 1 country.
About this study
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
- Being tested
- A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant, A/H5N1 inactivated, split-virion influenza vaccine
- Keywords
- Pandemic influenza, Avian influenza, Orthomyxoviridae Infections, A/H5N1
- Medical subject headings
- Orthomyxoviridae Infections, Influenza in Birds
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 vaccine+AdjuvantBiological
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantBiological
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantBiological
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantBiological
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccineBiological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dose 1 with Adjuvant Receives: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant |
| Group 2 | Experimental | Dose 2 with adjuvant Receives: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant |
| Group 3 | Experimental | Dose 3 with adjuvant Receives: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant |
| Group 4 | Experimental | Dose 4 with adjuvant Receives: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant |
| Group 5 | Active comparator | Control Receives: Biological: A/H5N1 inactivated, split-virion influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine
Measured: Entire study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pandemic 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 251 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
- NCT00457509
- Sponsor's protocol ID
- GPF01
- Status last verified
- Jan 2014
- First submitted
- 5 Apr 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9. doi: 10.1086/590913.
PubMed 18576945
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 H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00457509
- Acronym / sponsor ID
- GPF01
- Keywords
- Pandemic influenza, Avian influenza, Orthomyxoviridae Infections, A/H5N1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Apr 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 purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantDose 1 with Adjuvant |
| Group 2 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantDose 2 with adjuvant |
| Group 3 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantDose 3 with adjuvant |
| Group 4 | Experimental | Biological: A/H5N1 inactivated, split-virion influenza vaccine+AdjuvantDose 4 with adjuvant |
| Group 5 | Active comparator | Biological: A/H5N1 inactivated, split-virion influenza vaccineControl |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 40 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.
Key exclusion criteria (18 listed)
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
- Vaccination with an influenza vaccine during the past 6 months
- Any vaccination in the 4 weeks preceding the first trial 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 vaccine+Adjuvant0.5 mL, Intramuscular | Biological | Group 1 |
| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant0.5 mL, Intramuscular | Biological | Group 2 |
| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant0.5 mL, Intramuscular | Biological | Group 3 |
| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant0.5 mL, Intramuscular | Biological | Group 4 |
| A/H5N1 inactivated, split-virion influenza vaccine0.5 mL, Intramuscular | Biological | Group 5 |
Primary outcome
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine
Time frame: Entire study period
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 18576945Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9. doi: 10.1086/590913.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant and A/H5N1 inactivated, split-virion influenza vaccine in people with Pandemic Influenza and Influenza A Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 3 sites in Belgium.
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 4 inclusion and 18 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 3 sites in Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 A/H5N1 Inactivated split influenza virus vaccine (time frame: Entire study period). 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 NCT00457509, which also lists 1 linked publication.
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.