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Yearly Strain Variation Study, 2009/2010 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Yearly Strain Variation Study, 2009/2010

An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population

NCT00943657•Alachua Government Services, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
•Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
•Subject has given written informed consent prior to study entry
•Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
•Subject agrees to keep a daily record of symptoms for the duration of the study
•If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
•Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria

•Subject has a history of severe allergic reaction or anaphylaxis
•Subject has an oral temperature of \>= 37.5°C on the day of vaccination in this study
•Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
•Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
•Subject has received a seasonal influenza vaccine within 6 months of study entry
•Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
•Subject has any inherited or acquired immunodeficiency
•Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
•Subject has a functional or surgical asplenia
•Subject has a known or suspected problem with alcohol or drug abuse
+2 more criteria

Locations (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Austria

Key Dates

Start Date

June 1, 2009

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

October 9, 2015

Enrollment

110

ESTIMATED participants

Conditions

InfluenzaSeasonal Influenza

Interventions

Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]

BIOLOGICAL

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

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Influenza

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RECRUITINGPHASE3

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

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Influenza

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RECRUITINGNA

Dime La VerDAD: Verify, Debunk, and Disseminate

NCT06417762

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Yearly Strain Variation Study, 2009/2010

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Dime La VerDAD: Verify, Debunk, and Disseminate

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility