InfluenzaPhase 3NCT00554333
Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine
A Phase 3 study testing Flu-ID 15μg and Inactivated adjuvanted Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 8 sites in 2 countries.
Trial summary
Primary objective: Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres Secondary objectives Immunogenicity To describe the immune… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flu-ID 15μg and Inactivated adjuvanted Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 795 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2007to Dec 2007
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or older on the day of inclusion
Who cannot join
- Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Unstable chronic illness
- Congenital or acquired immunodeficiency,
- Any blood or blood-derived product in the past 3 months
- Current abuse of alcohol or drug addiction
Show all 9Show fewer
- Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
- Any vaccination against influenza in the past 6 months
- Subjects who previously received a vaccination against influenza by intradermal route
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France5 sites
Study site
Angers
Study site
Cherbourg
Study site
Laval
Study site
Seysses
Study site
Tiercé
About this study
Official title: An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older
Primary objective:
- Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres
Read more
Secondary objectives
- Immunogenicity
- To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
- To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
- Safety
- To describe the safety profile after vaccination in each group
- Acceptability
- To describe the pain at the injection site
- To describe the comfort of the injection
- Conditions
- Influenza
- Being tested
- Flu-ID 15μg, Inactivated adjuvanted Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu-ID 15μgBiological
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
Inactivated adjuvanted Influenza VaccineBiological
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Inactivated Split-Virion Influenza Vaccine for Intradermal Route Receives: Biological: Flu-ID 15μg |
| 2 | Active comparator | Inactivated adjuvanted Influenza Vaccine for Intramuscular Route Receives: Biological: Inactivated adjuvanted Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
Measured: 21 days
Secondary outcomes (10)
Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]
Measured: 21 days
Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21
Measured: 21 days
Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0
Measured: 21 days
Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil)
Measured: 21 days
Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination
Measured: 7 days
Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96]
Measured: 3 days
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2
Measured: 21 days (plus or minus 3 days)
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2
Measured: 21 days (plus or minus 3 days)
Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale
Measured: 1 day (day of vaccination)
Answers to the Vaccination Comfort Questionnaire completed on D21
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 795 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, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554333
- Sponsor's protocol ID
- FID01C
- Status last verified
- Mar 2018
- First submitted
- 5 Nov 2007
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.
PubMed 20504306
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older
- ClinicalTrials.gov ID
- NCT00554333
- Acronym / sponsor ID
- FID01C
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 795 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Nov 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.
Primary objective:
- Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres
Secondary objectives
- Immunogenicity
- To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
- To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
- Safety
- To describe the safety profile after vaccination in each group
- Acceptability
- To describe the pain at the injection site
- To describe the comfort of the 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: Flu-ID 15μgInactivated Split-Virion Influenza Vaccine for Intradermal Route |
| 2 | Active comparator | Biological: Inactivated adjuvanted Influenza VaccineInactivated adjuvanted Influenza Vaccine for Intramuscular Route |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Aged 65 years or older on the day of inclusion
Key exclusion criteria (9 listed)
- Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Unstable chronic illness
- Congenital or acquired immunodeficiency,
- Any blood or blood-derived product in the past 3 months
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 |
|---|---|---|
| Flu-ID 15μgInactivated Split-Virion Influenza Vaccine for Intradermal Route | Biological | 1 |
| Inactivated adjuvanted Influenza VaccineInactivated adjuvanted Influenza Vaccine for Intramuscular Route | Biological | 2 |
Primary outcome
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
Time frame: 21 days
10 secondary outcomes
Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]
Time frame: 21 days
Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21
Time frame: 21 days
Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0
Time frame: 21 days
Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil)
Time frame: 21 days
Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination
Time frame: 7 days
Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96]
Time frame: 3 days
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2
Time frame: 21 days (plus or minus 3 days)
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2
Time frame: 21 days (plus or minus 3 days)
Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale
Time frame: 1 day (day of vaccination)
Answers to the Vaccination Comfort Questionnaire completed on D21
Time frame: 21 days
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 16 Mar 2018.
- Derived from this study: PubMed 20504306Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.
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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, a Sanofi Company
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flu-ID 15μg and Inactivated adjuvanted Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 8 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 1 inclusion and 9 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 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. (time frame: 21 days). 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 NCT00554333, 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 16 Mar 2018.