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

Influenza Clinical Trial

Official title:

Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-derived Influenza Vaccine for Season 2003/2004

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161837
• Other study ID #: 227
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: October 7, 2015
• Start date: December 2003
• Est. completion date: July 2004

Study information

• Verified date: October 2006
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Vero Cell-derived Influenza Vaccine

• Egg-derived Influenza Vaccine

Locations

Country	Name	City	State
Poland	PANTAMED Sp.z o.o.	Olsztyn

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

Poland,