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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010598-19 |
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Annual trial for registration influenza vaccine with the strain composition for season 2009/2010.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | One 0.5mL dose of Inactivated, Influenza Vaccine using the strain composition 2009/2010 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects | 21(-1/+5) days | |
| Evaluation of safety of a single intramuscular injection of influenza vaccine in non elderly adult and elderly subjects | 21(-1/+5) days |
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Inclusion Criteria:
Exclusion Criteria:
They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study and suspected or known HIV infection or HIV-related disease;
They have a known or suspected history of drug or alcohol abuse;
They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom or diaphragm), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
Within the past 12 months, they have:- received more than one injection of influenza vaccine
Within the past 6 months, they have:-had laboratory confirmed influenza disease,- received influenza vaccine;
Within the past 4 weeks they have received:-another vaccine;-any investigational agent;
They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
They have experienced fever (i.e., axillary temperature≥ 38°C) within the last 3 days;
They are taking part in another clinical study;
They have any condition which, in the opinion of the investigator,might interfere with the evaluation of the study objectives;
They are severely obese with Body Mass Index (BMI) > 35;
Site personnel involved in the evaluation of safety and their immediate relatives are excluded from participation.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini | Chieti | 66100 | Italy | |||
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| Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37 ----- Satellite sites: (a) Distretto Sanitario di Base, Via Don Minzoni, Lanciano (CH) and (b) Distretto Sanitario di Base, Via Polidoro, Fossacesia (CH)) |
| Lanciano |
| 66034 |
| Italy |
| Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48 | Pianiga | 30030 | Italy |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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