- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00170482
Elderly Influenza Vaccine Immunogenicity Substudy
In Depth Immunologic Studies in Elderly Subjects Receiving Either Standard-Dose Fluzone (15mcg HA/Virus Strain) or High-Dose (60 mcg HA/Virus Strain) Trivalent Inactivated Influenza Virus Vaccine
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201-1509
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
1. Volunteers who participate in Division of Microbiology and Infectious Diseases (DMID) study 04-100, "Comparisons of the Reactogenicity and Immunogenicity in Ambulatory Elderly Subjects of a Standard-Dose Fluzone® (15 µg HA/Virus Strain) and a High-Dose (60 µg HA/Virus Strain) of a Trivalent Inactivated Influenza Virus Vaccine" 2. Ambulatory medically stable persons at least 65 years of age on the date of vaccination 2. Provides written informed consent and will be available for all study visits 4. Able to understand and comply with planned study procedures Subjects will be considered ambulatory if they are not institutionalized, bedridden, or homebound. Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs must be controlled with medical therapy. Subjects with acute febrile illnesses [oral temperature equal to or exceeding 99.5 degrees F (37.5 degrees C)] will be deferred until 3 days after illness resolution.
Exclusion Criteria:
1. Known allergy to eggs or other components of the vaccine (eg, thimerosal) 2. History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances 3. History of Guillain-Barré Syndrome 4. Immunosuppression as a result of underlying illness or treatment 5. Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (> 800 µg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination 6. Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination 7. Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy) 8. Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus 9. Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental vaccines or medications during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine 10. Use of experimental devices or participation in a medical procedure trial within the month prior to study entry, or expected use of experimental devices or participation in a medical procedure trial during the entire study period, including the 6-month follow-up phone call, after inoculation with study vaccine 11. Receipt of immunoglobulin or other blood product within 3 months prior to enrollment 12. Receipt of other licensed vaccines within the preceding 4 weeks or expected to receive a licensed vaccine within 1 month (prior to visit 2) following trial vaccination 13. Subject is enrolled in a conflicting clinical trial 14. Thrombocytopenia or bleeding disorder or therapy contraindicating intramuscular (IM) vaccination.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zeitperspektiven: Interessent
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 05-0028
Arzneimittel- und Geräteinformationen, Studienunterlagen
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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