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

NCT00161837 | Completed Phase 2

• 1 other identifier: 227
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Influenza; Vaccine

Interventions

Vero Cell-derived Influenza Vaccine BIOLOGICAL

Egg-derived Influenza Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (1)

PANTAMED Sp.z o.o.

Olsztyn, PL-10-461, Poland

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jerzy Romaszko, MD

  PANTAMED sp. z o o.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: December 1, 2003
• Study Completion: July 1, 2004
• Last Updated: October 9, 2015

Record last verified: 2006-10

Locations

PL (1)