Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)

NCT ID: NCT00289510

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Inactivated influenza vaccine (whole virion, Vero cell-derived)

Intervention Type: BIOLOGICAL

Inactivated influenza vaccine (egg derived) [licensed control vaccine]

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Markus Müller, MD

Role: PRINCIPAL_INVESTIGATOR

Allgemeines Krankenhaus Wien (General Hospital Vienna)

Kasra Shakeri-Nejad, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Westend, Berlin

Bernhard Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz

Alen Jambrecina, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services Germany GmbH, Hamburg

Stephan De la Motte, MD

Role: PRINCIPAL_INVESTIGATOR

Harrison Clinical Research / Clinical Unit, Munich

Locations

Allgemeines Krankenhaus Wien (General Hospital Vienna)

Vienna, , Austria

Klinikum Westend, Haus 18

Berlin, , Germany

Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)

Mainz, , Germany

Countries

Austria; Germany

Other Identifiers

710501

Identifier Type: -

Identifier Source: org_study_id