Orthomyxoviridae InfectionPhase 3NCT00383539
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
A Phase 3 study testing Inactivated Split-virion influenza vaccine in people with Orthomyxoviridae Infection and Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 sites in 4 countries.
Trial summary
The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthomyxoviridae Infection, Influenza, Myxovirus Infection
- What is being tested?
- Inactivated Split-virion influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,256 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2006to 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 60 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 the first visit.
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 (oral temperature >= 37.5°C, or rectal equivalent temperature >= 38.0°C) on the day of inclusion.
- Participation in another clinical trial in the 4 weeks preceding the 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 6 months, or long-term systemic corticosteroids therapy.
- Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion.
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- 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 3 months.
- Any vaccination in the 4 weeks preceding the trial vaccination.
- Vaccination planned in the 4 weeks following the trial vaccination.
- Previous vaccination against influenza (in the previous 6 months).
- Thrombocytopenia or bleeding disorder contraindicating intramuscular 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 4 countries.
4 sites in 4 countries
About this study
The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.
Secondary Objectives:
Read more
Immunogenicity
To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.
To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).
Safety:
To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.
To describe the safety profile after vaccination.
Comfort of the vaccination assessment:
To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.
- Conditions
- Orthomyxoviridae Infection, Influenza, Myxovirus Infection
- Being tested
- Inactivated Split-virion influenza vaccine
- Keywords
- Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Adults
- 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
Vaccine Lot 1
Inactivated Split-virion influenza vaccineBiological
Vaccine Lot 2
Inactivated Split-virion influenza vaccineBiological
Vaccine Lot 3
Inactivated Split-virion influenza vaccineBiological
Also called Vaxigrip
Control Vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lot 1 Receives: Biological: Inactivated Split-virion influenza vaccine |
| 2 | Experimental | Lot 2 Receives: Biological: Inactivated Split-virion influenza vaccine |
| 3 | Experimental | Lot 3 Receives: Biological: Inactivated Split-virion influenza vaccine |
| 4 | Active comparator | Control 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 the immunogenicity of an inactivated, split-virion influenza vaccine
Measured: 21 Days pot-vaccination
Secondary outcomes (1)
To provide information concerning the safety of an inactivated, split-virion influenza 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 posted3 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthomyxoviridae InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,256 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
- NCT00383539
- Sponsor's protocol ID
- GID23
- Status last verified
- Jan 2014
- First submitted
- 29 Sep 2006
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnou R, Eavis P, Pardo JR, Ambrozaitis A, Kazek MP, Weber F. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years: Randomized, controlled, phase III trial. Hum Vaccin. 2010 Apr;6(4):346-54. doi: 10.4161/hv.6.4.10961. Epub 2010 Apr 15.
PubMed 20372053Chevat 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
- Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
- ClinicalTrials.gov ID
- NCT00383539
- Acronym / sponsor ID
- GID23
- Conditions
- Orthomyxoviridae Infection, Influenza, Myxovirus Infection
- Keywords
- Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,256 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Oct 2006 (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 primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.
Secondary Objectives:
Immunogenicity
To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.
To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).
Safety:
To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.
To describe the safety profile after vaccination.
Comfort of the vaccination assessment:
To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Inactivated Split-virion influenza vaccineLot 1 |
| 2 | Experimental | Biological: Inactivated Split-virion influenza vaccineLot 2 |
| 3 | Experimental | Biological: Inactivated Split-virion influenza vaccineLot 3 |
| 4 | Active comparator | Biological: Inactivated Split-virion influenza vaccineControl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 60 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 the first visit.
Key exclusion criteria (13 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 (oral temperature >= 37.5°C, or rectal equivalent temperature >= 38.0°C) on the day of inclusion.
- Participation in another clinical trial in the 4 weeks preceding the 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 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 vaccineVaccine Lot 1 | Biological | 1 |
| Inactivated Split-virion influenza vaccineVaccine Lot 2 | Biological | 2 |
| Inactivated Split-virion influenza vaccineVaccine Lot 3 | Biological | 3 |
| Inactivated Split-virion influenza vaccineAlso: VaxigripControl Vaccine | Biological | 4 |
Primary outcome
To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine
Time frame: 21 Days pot-vaccination
1 secondary outcome
To provide information concerning the safety of an inactivated, split-virion influenza 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 14 Jan 2014.
- Derived from this study: PubMed 20372053Arnou R, Eavis P, Pardo JR, Ambrozaitis A, Kazek MP, Weber F. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years: Randomized, controlled, phase III trial. Hum Vaccin. 2010 Apr;6(4):346-54. doi: 10.4161/hv.6.4.10961. Epub 2010 Apr 15.
- 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 Monitor study director
Sanofi Pasteur Inc.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated Split-virion influenza vaccine in people with Orthomyxoviridae Infection and Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 sites in 4 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 4 inclusion and 13 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 France, Lithuania, Spain, United Kingdom. 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?
To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine (time frame: 21 Days pot-vaccination). 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 NCT00383539, which also lists 2 linked publications.
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.