Single-blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero cell derived) with a Licensed Egg derived Influenza Vaccine - Phase 1/2 Modified Whole Virus Influenza Vaccine Trial

• Conditions: Influenza Vaccination in healthy subjects

• Registration Number: EUCTR2005-004164-23-DE
• Lead Sponsor: Baxter AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

Male and female subjects will be eligible for participation in this study if they:

ØAre 18 to 45 years of age, inclusive, on the day of screening;

ØHave an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;

ØAre clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);

ØAgree to keep a daily record of symptoms;

ØIf female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from participation in this study if they:

ØHave received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;

ØHave received any vaccination within 2 weeks prior to vaccination in this study;

ØSuffer from any kind of immunodeficiency;

ØSuffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immune response;

ØHave a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);

ØHave received a blood transfusion or immunoglobulins within 30 days of study entry;

ØHave donated blood or plasma within 30 days of study entry;

ØHave a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine);

ØHave a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;

ØHave a known or suspected problem with alcohol or drug abuse;

ØAre unable to lead an independent life as a result of either physical or mental handicap;

ØWere administered an investigational drug within six weeks prior to study entry;

ØAre concurrently participating in a clinical study that includes the administration of an investigational product;

ØIf female, are pregnant or lactating;

ØAre a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ØAssess the safety of inactivated influenza vaccine (whole virion, Vero cell derived) in comparison to egg derived vaccine.<br>;Secondary Objective: ØAssesss the immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived) in comparison to egg derived vaccine.<br>;Primary end point(s): The primary study endpoint is the number of subjects with temperatures >= 38.0°C and onset within 2 days after vaccination.