Orthomyxoviridae InfectionsPhase 2NCT00258934
Immunogenicity Study of the Influenza Vaccine in Adults
A Phase 2 study testing Inactivated, split-virion influenza vaccine and Inactivated, split-virion, influenza virus in people with Orthomyxoviridae Infections and Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 sites in 3 countries.
Trial summary
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthomyxoviridae Infections, Influenza
- What is being tested?
- Inactivated, split-virion influenza vaccine and Inactivated, split-virion, influenza virus
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 978 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2005to 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 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 57 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 at V01
- 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 four weeks after, the first vaccination.
- At Year 1 (Visit 05):
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- -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05
- At Year 2 (Visit 07):
- -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07
Who cannot join
- Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components; in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Febrile illness (rectal equivalent temperature >= 38.0°C) on the day of inclusion
- Breast-feeding
- Participation in another clinical trial in the four weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency; immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months; or long-term systemic corticosteroid therapy.
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- 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
- Blood or blood-derived products received in the past three months
- Any vaccination in the four weeks preceding the first trial vaccination
- Vaccination planned in the four weeks following the first trial vaccination
- Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
- Thrombocytopenia or bleeding disorder contraindicating IM 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 3 countries.
4 sites in 3 countries
About this study
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions.
Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes.
Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.
- Conditions
- Orthomyxoviridae Infections, Influenza
- Being tested
- Inactivated, split-virion influenza vaccine, Inactivated, split-virion, influenza virus
- Keywords
- Influenza, Orthomyxoviruses, Inactivated, Split-virion influenza vaccine, adults, Myxovirus Infection, Orthomyxovirus Infection
- Medical subject headings
- Orthomyxoviridae Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated, split-virion influenza vaccineBiological
0.1 mL single annual dose
Inactivated, split-virion, influenza virusBiological
Also called Vaxigrip®
0.5 mL single annual dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Inactivated, split-virion influenza vaccine |
| 2 | Active comparator | Not described Receives: Biological: 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 influenza vaccination.
Measured: 21 Days and 2 Years 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 posted28 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2008
- Study completionSep 2008
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 Orthomyxoviridae InfectionsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258934
- Sponsor's protocol ID
- GID15
- Status last verified
- Jan 2014
- First submitted
- 24 Nov 2005
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.
PubMed 19261173
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 Study of the Influenza Vaccine in Adults
- ClinicalTrials.gov ID
- NCT00258934
- Acronym / sponsor ID
- GID15
- Conditions
- Orthomyxoviridae Infections, Influenza
- Keywords
- Influenza, Orthomyxoviruses, Inactivated, Split-virion influenza vaccine, adults, Myxovirus Infection, Orthomyxovirus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 978 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 28 Nov 2005 (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.
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions.
Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes.
Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Inactivated, split-virion influenza vaccine |
| 2 | Active comparator | Biological: Inactivated, split-virion, influenza virus |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged 18 to 57 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 at V01
- 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 four weeks after, the first vaccination.
Key exclusion criteria (14 listed)
- Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components; in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Febrile illness (rectal equivalent temperature >= 38.0°C) on the day of inclusion
- Breast-feeding
- Participation in another clinical trial in the four 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 |
|---|---|---|
| Inactivated, split-virion influenza vaccine0.1 mL single annual dose | Biological | 1 |
| Inactivated, split-virion, influenza virusAlso: Vaxigrip®0.5 mL single annual dose | Biological | 2 |
Primary outcome
To provide information concerning the immunogenicity of influenza vaccination.
Time frame: 21 Days and 2 Years 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.
- Derived from this study: PubMed 19261173Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.
- 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 Director study director
Sanofi Pasteur Inc.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inactivated, split-virion influenza vaccine and Inactivated, split-virion, influenza virus in people with Orthomyxoviridae Infections and Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 sites in 3 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 9 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, Germany, Switzerland. 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 influenza vaccination. (time frame: 21 Days and 2 Years post-vaccination 1). 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 NCT00258934, 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.