Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

NCT ID: NCT00161837

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2004-07-31

Brief Summary

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

Conditions

Influenza

Study Design

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

Interventions

Vero Cell-derived Influenza Vaccine

Intervention Type: BIOLOGICAL

Egg-derived Influenza Vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• are >= 18 and <= 60 years old (for Stratum A only);
• are > 60 years old (for Stratum B only);
• are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
• 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 - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria

Male and female subjects will be excluded from participation in this study if they:

• have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 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 immunological functions;
• have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
• have received a blood transfusion or immunoglobulins within one month of study entry;
• have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
• 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;
• had administration of an investigational drug within six weeks prior to the study start;
• are concurrently participating in a clinical trial;
• are pregnant or lactating.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jerzy Romaszko, MD

Role: PRINCIPAL_INVESTIGATOR

PANTAMED sp. z o o.

Locations

PANTAMED Sp.z o.o.

Olsztyn, , Poland

Countries

Poland

Other Identifiers

227

Identifier Type: -

Identifier Source: org_study_id