InfluenzaPhase 1NCT00664417
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
A Phase 1 study testing Monovalent subvirion H5N1 influenza vaccine and Physiological saline in people with Influenza and Orthomyxoviridae Infections, run by Sanofi at 6 sites in United States.
Trial summary
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviridae Infections
- What is being tested?
- Monovalent subvirion H5N1 influenza vaccine and Physiological saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2008to Aug 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
- Healthy adult aged 18 to 40 years on the day of inclusion.
- Provides signed informed consent prior to study procedures.
- Able to attend all scheduled visits and comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Who cannot join
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances
- For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
- Breast feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, oral, parenteral, or inhaled steroids
Show all 20Show fewer
- Has an acute or chronic medical illness or any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or would interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol
- Known or suspected current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- History of receipt of blood or immunoglobulin or other blood-derived products within the 3 months prior to enrollment in this study 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 preceding or following any trial vaccination
- Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity
- Personal or family history of Guillain-Barré Syndrome
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Active neoplastic disease or a history of any hematologic malignancy
- Previous participation in a pandemic flu trial
- History of H5N1 infection or exposure to presumed/confirmed H5N1 human/animal cases
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study.
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Knoxville, Tennessee, 37920
Study site
San Diego, California, 92103
Study site
South Miami, Florida, 33143
Study site
Springfield, Missouri, 65802
About this study
Official title: Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Read the detailed description
This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.
- Conditions
- Influenza, Orthomyxoviridae Infections
- Being tested
- Monovalent subvirion H5N1 influenza vaccine, Physiological saline
- Keywords
- Influenza, A/H5N1, 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.
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Formulation 1
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Formulation 2
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Formulation 3
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Formulation 4
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Formulation 5
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Formulation 6
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Comparator 1
Monovalent subvirion H5N1 influenza vaccineBiological
0.5 mL, IM, 2 injections, Comparator 2
Physiological salineBiological
0.5 mL, IM, 2 injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 2 | Experimental | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 3 | Experimental | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 4 | Experimental | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 5 | Experimental | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 6 | Experimental | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 7 | Active comparator | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 8 | Active comparator | Not described Receives: Biological: Monovalent subvirion H5N1 influenza vaccine |
| 9 | Placebo comparator | Not described Receives: Biological: Physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety after primary administration of A/H1N1 vaccine
Measured: 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionAug 2010
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 SanofiThe 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
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664417
- Sponsor's protocol ID
- FUF04
- Status last verified
- Apr 2012
- First submitted
- 22 Apr 2008
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00664417
- Acronym / sponsor ID
- FUF04
- Conditions
- Influenza, Orthomyxoviridae Infections
- Keywords
- Influenza, A/H5N1, Orthomyxoviridae Infections, Influenza Pandemics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Apr 2008 (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.
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Detailed description
This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 2 | Experimental | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 3 | Experimental | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 4 | Experimental | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 5 | Experimental | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 6 | Experimental | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 7 | Active comparator | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 8 | Active comparator | Biological: Monovalent subvirion H5N1 influenza vaccine |
| 9 | Placebo comparator | Biological: Physiological saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult aged 18 to 40 years on the day of inclusion.
- Provides signed informed consent prior to study procedures.
- Able to attend all scheduled visits and comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Key exclusion criteria (20 listed)
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances
- For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
- Breast feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
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 |
|---|---|---|
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Formulation 1 | Biological | 1 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Formulation 2 | Biological | 2 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Formulation 3 | Biological | 3 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Formulation 4 | Biological | 4 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Formulation 5 | Biological | 5 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Formulation 6 | Biological | 6 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Comparator 1 | Biological | 7 |
| Monovalent subvirion H5N1 influenza vaccine0.5 mL, IM, 2 injections, Comparator 2 | Biological | 8 |
| Physiological saline0.5 mL, IM, 2 injections | Biological | 9 |
Primary outcome
To provide information concerning the safety after primary administration of A/H1N1 vaccine
Time frame: 6 months 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 17 Apr 2012.
- 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.
6 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 Monovalent subvirion H5N1 influenza vaccine and Physiological saline in people with Influenza and Orthomyxoviridae Infections, run by Sanofi at 6 sites in United States.
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 20 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 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. 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 after primary administration of A/H1N1 vaccine (time frame: 6 months post-vaccination). 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 17 Apr 2012.