Clinical trial NCT00289510: Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)
Official title: 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 License Egg Derived Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.


Eligibility criteria: Inclusion Criteria:

Male and female subjects who

* are 18 to 45 years of age, inclusive, on the day of screening;
* have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
* are 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);
* agree to keep a daily record of symptoms;
* if 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.

Exclusion Criteria:

Subjects who

* have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
* have received any vaccination within 2 weeks prior to vaccination in this study;
* suffer from any kind of immunodeficiency;
* suffer 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;
* have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
* have received a blood transfusion or immunoglobulins within 30 days of study entry;
* have donated blood or plasma within 30 days of study entry;
* have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
* have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
* have a known or suspected problem with alcohol or drug abuse;
* are unable to lead an independent life as a result of either physical or mental handicap;
* were administered an investigational drug within six weeks prior to study entry;
* are concurrently participating in a clinical study that includes the administration of an investigational product;
* if female, are pregnant or lactating;
* are 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien (General Hospital Vienna)
city: Berlin
country: Germany
facility: Klinikum Westend, Haus 18
city: Mainz
country: Germany
facility: Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)
Study officials:
affiliation: Allgemeines Krankenhaus Wien (General Hospital Vienna)
name: Markus Müller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Westend, Berlin
name: Kasra Shakeri-Nejad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz
name: Bernhard Schmitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MDS Pharma Services Germany GmbH, Hamburg
name: Alen Jambrecina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harrison Clinical Research / Clinical Unit, Munich
name: Stephan De la Motte, MD
role: PRINCIPAL_INVESTIGATOR
References: