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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
Safety
- To describe the safety profile after vaccination in each group
Acceptability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Inactivated Split-Virion Influenza Vaccine for Intradermal Route |
|
| 2 | Active Comparator | Inactivated adjuvanted Influenza Vaccine for Intramuscular Route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flu-ID 15μg | Biological | Inactivated Split-Virion Influenza Vaccine for Intradermal Route |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0] | 21 days | |
| Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21 | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20504306 | Derived | 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. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Inactivated adjuvanted Influenza Vaccine |
| Biological |
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route |
|
| 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 | 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) | 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 | 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] | 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 | 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 | 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 | 1 day (day of vaccination) |
| Answers to the Vaccination Comfort Questionnaire completed on D21 | 21 days |
| Massemen |
| Belgium |
| Wilrijk | Belgium |
| Angers | France |
| Cherbourg | France |
| Laval | France |
| Seysses | France |
| Tiercé | France |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |