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All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip).
Primary Objective:
To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine.
Secondary Objectives:
Observational Objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated, split-virion influenza vaccine | Biological |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | 5000 | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18652550 | Derived | Holland D, Booy R, De Looze F, Eizenberg P, McDonald J, Karrasch J, McKeirnan M, Salem H, Mills G, Reid J, Weber F, Saville M. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis. 2008 Sep 1;198(5):650-8. doi: 10.1086/590434. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Carina Heights |
| QLD 4152 |
| Australia |
| Inala | QLD 4077 | Australia |
| Kippa-Ring | QLD 4021 | Australia |
| Victoria | 3079 | Australia |
| Victoria | 3128 | Australia |
| Victoria | 3144 | Australia |
| Westmead | NSW 2145 | Australia |
| Auckland | New Zealand |
| Dunedin | New Zealand |
| Hamilton | New Zealand |
| 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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