Clinical trial NCT00161811: Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005
Official title: Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.


Eligibility criteria: Inclusion Criteria:

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

* are \>= 18 and \<= 60 years old on the day of screening (for Stratum A only);
* are \> 60 years old on the day of screening (for Stratum B only);
* 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);
* will reliably keep a daily record of symptoms;
* understand the nature of the study, agree to its provisions, and give written informed consent;
* if female and capable of bearing children - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

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

* have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 season;
* 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, chemotherapeutics) that can be expected to influence the normal immunologic functions;
* 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 or other known contraindications);
* have a rash or dermatological condition which may interfere with injection site reaction rating;
* have a known or suspected problem with drug or alcohol abuse;
* are unable to lead an independent life either physically or mentally;
* were administered an investigational drug within six weeks prior to study entry;
* are concurrently participating in a clinical study including the administration of an investigational product;
* if female, are pregnant or lactating.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital (AKH), Department of Clinical Pharmacology
city: Henningsdorf
country: Germany
facility: Neuendorfstr. 20
city: Mainz
country: Germany
facility: Münstererstr. 1a
city: Mainz
country: Germany
facility: Mainz University Children´s Clinic
Study officials:
affiliation: Vienna General Hospital (AKH), Department of Clinical Pharmacology
name: Markus Müller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mainz University Children´s Clinic, Center for Clinical Studies
name: Pirmin Habermehl, MD
role: PRINCIPAL_INVESTIGATOR
References: