Yearly Strain Variation Study, 2009/2010

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943657
• Other study ID #: 720901
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2009
• Last updated: October 7, 2015
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health Family and Youth
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study

• If female, subject is pregnant or lactating at the time of study enrollment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
Single intramuscular injection of vaccine

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination		21 days	Yes