Status:
COMPLETED
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011
Lead Sponsor:
Novartis Vaccines
Conditions:
Seasonal Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects
Eligibility Criteria
Inclusion
- Key
- Males and females volunteers of 65 years of age or older
- Mentally competent
- Willing and able to give written informed consent prior to study entry.
- Able to comply with all the study requirements.
- In general good health
- Key
Exclusion
- Any serious chronic or acute disease
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
- Known or suspected impairment/alteration of immune function
- Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
- Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01152814
Start Date
June 1 2010
End Date
July 1 2010
Last Update
January 27 2016
Active Locations (6)
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1
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, Italy, 66100
2
Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
Ferrara, Italy, 44100
3
Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
Genova, Italy, 16132
4
Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
Lanciano, Italy, 66034