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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lot 1 |
|
| 2 | Experimental | Lot 2 |
|
| 3 | Experimental | Lot 3 |
|
| 4 | Active Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Split-virion influenza vaccine | Biological | Vaccine Lot 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine | 21 Days pot-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety of an inactivated, split-virion influenza vaccine. | 6 months post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | 49000 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20372053 | Derived | 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. | |
| 19261173 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| Inactivated Split-virion influenza vaccine |
| Biological |
Vaccine Lot 2 |
|
| Inactivated Split-virion influenza vaccine | Biological | Vaccine Lot 3 |
|
| Inactivated Split-virion influenza vaccine | Biological | Control Vaccine |
|
|
| Vilnius |
| 08117 |
| Lithuania |
| Madrid | 28041 | Spain |
| Bath | United Kingdom |
| 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. |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C478242 | vaxigrip |
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