InfluenzaPhase 2NCT00776438
Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
A Phase 2 study testing Inactivated, split-virion, influenza vaccine and Inactivated, split-virion influenza vaccine in people with Influenza and Orthomyxovirus Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in France.
Trial summary
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: To describe the immune response per age group and vaccine group after vaccination. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Influenza, Orthomyxovirus Infections, Myxovirus Infection
- What is being tested?
- Inactivated, split-virion, influenza vaccine and 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
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Apr 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
- Provision of a signed informed consent
- 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 vaccination, until 4 weeks after vaccination
- Entitlement to national social security.
Who cannot join
- For a woman of child-bearing potential, known pregnancy or positive 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 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, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
Show all 16Show fewer
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Current alcohol abuse or drug addiction, which may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
- Previous vaccination against Influenza in the previous 6 months
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (oral temperature >=37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.
Objectives:
- To describe the immune response per age group and vaccine group after vaccination.
- To describe the safety of the vaccines per age group and per vaccine group after vaccination.
- Conditions
- Influenza, Orthomyxovirus Infections, Myxovirus Infection
- Being tested
- Inactivated, split-virion, influenza vaccine, Inactivated, split-virion influenza vaccine
- Keywords
- Influenza, Orthomyxoviruses, Myxovirus Infection, Inactivated Split-virion influenza vaccine, Adults, Elderly
- 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.
Inactivated, split-virion, influenza vaccineBiological
0.1 mL, Intradermal
Inactivated, split-virion, influenza vaccineBiological
Also called Vaxigrip®
0.5 mL, Intramuscular
Inactivated, split-virion influenza vaccineBiological
0.1 mL, Intradermal
Inactivated, split-virion influenza vaccineBiological
Also called Vaxigrip®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Adult, age 18 to 40 years Receives: Biological: Inactivated, split-virion, influenza vaccine |
| Study Group 2 | Experimental | Adult, age 18 to 40 years Receives: Biological: Inactivated, split-virion, influenza vaccine |
| Study Group 3 | Experimental | Elderly, age 60 to 85 years Receives: Biological: Inactivated, split-virion influenza vaccine |
| Study Group 4 | Experimental | Elderly, age 60 to 85 years Receives: Biological: 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 immune response to an inactivated, split-virion, influenza vaccine.
Measured: 21 days post-vaccination
To provide information concerning the safety of inactivated, split-virion, influenza vaccine.
Measured: 21 days post-vaccination and entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2009
- Study completionApr 2009
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT00776438
- Sponsor's protocol ID
- GID25
- Status last verified
- Jun 2015
- First submitted
- 17 Oct 2008
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nougarede N, Bisceglia H, Rozieres A, Goujon C, Boudet F, Laurent P, Vanbervliet B, Rodet K, Hennino A, Nicolas JF. Nine mug intradermal influenza vaccine and 15 mug intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults. Hum Vaccin Immunother. 2014;10(9):2713-20. doi: 10.4161/hv.29695.
PubMed 25483667
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route
- ClinicalTrials.gov ID
- NCT00776438
- Acronym / sponsor ID
- GID25
- Conditions
- Influenza, Orthomyxovirus Infections, Myxovirus Infection
- Keywords
- Influenza, Orthomyxoviruses, Myxovirus Infection, Inactivated Split-virion influenza vaccine, Adults, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Oct 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.
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.
Objectives:
- To describe the immune response per age group and vaccine group after vaccination.
- To describe the safety of the vaccines per age group and per vaccine group after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Biological: Inactivated, split-virion, influenza vaccineAdult, age 18 to 40 years |
| Study Group 2 | Experimental | Biological: Inactivated, split-virion, influenza vaccineAdult, age 18 to 40 years |
| Study Group 3 | Experimental | Biological: Inactivated, split-virion influenza vaccineElderly, age 60 to 85 years |
| Study Group 4 | Experimental | Biological: Inactivated, split-virion influenza vaccineElderly, age 60 to 85 years |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
- Provision of a signed informed consent
- 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 vaccination, until 4 weeks after vaccination
- Entitlement to national social security.
Key exclusion criteria (16 listed)
- For a woman of child-bearing potential, known pregnancy or positive 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 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, or long-term systemic corticosteroids therapy
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, Intradermal | Biological | Study Group 1 |
| Inactivated, split-virion, influenza vaccineAlso: Vaxigrip®0.5 mL, Intramuscular | Biological | Study Group 2 |
| Inactivated, split-virion influenza vaccine0.1 mL, Intradermal | Biological | Study Group 3 |
| Inactivated, split-virion influenza vaccineAlso: Vaxigrip®0.5 mL, Intramuscular | Biological | Study Group 4 |
Primary outcome
To provide information concerning immune response to an inactivated, split-virion, influenza vaccine.
Time frame: 21 days post-vaccination
To provide information concerning the safety of inactivated, split-virion, influenza vaccine.
Time frame: 21 days post-vaccination and entire study duration
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 Jun 2015.
- Results publication: PubMed 25483667Nougarede N, Bisceglia H, Rozieres A, Goujon C, Boudet F, Laurent P, Vanbervliet B, Rodet K, Hennino A, Nicolas JF. Nine mug intradermal influenza vaccine and 15 mug intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults. Hum Vaccin Immunother. 2014;10(9):2713-20. doi: 10.4161/hv.29695.
- 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
1 site in 1 country: 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 vaccine in people with Influenza and Orthomyxovirus Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in France.
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 16 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 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 immune response to an inactivated, split-virion, influenza vaccine. (time frame: 21 days post-vaccination). The study lists 2 primary outcomes in all. 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 NCT00776438, 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 17 Jun 2015.