Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection - Full Text View

Purpose

The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.

Condition	Intervention	Phase
Influenza	Biological: Vero cell-derived, trivalent, seasonal influenza vaccine Biological: Placebo: Phosphate-buffered saline	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine to Prevent Culture Confirmed Influenza Infection

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

To demonstrate the efficacy of an investigational Vero cell-derived influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of subjects with seroconversion at Day 21 after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment:	7252
Study Start Date:	December 2008
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Vero cell-derived, trivalent, seasonal influenza vaccine	Biological: Vero cell-derived, trivalent, seasonal influenza vaccine Single intramuscular injection
Placebo Comparator: 2 Phosphate-buffered saline	Biological: Placebo: Phosphate-buffered saline Single intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject has an understanding of the study
Subject agrees to study provisions
Subject gives written informed consent prior to study entry
Subject is accessible by telephone or electronic mail to receive reminders from the study site
If female and capable of bearing children, subject has a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agrees to employ adequate birth control measures through the first 60 post-vaccination days.

Exclusion Criteria:

Subject has any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC, 2008a):
- Pregnancy
- Chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition)
- Chronic renal disorders
- Chronic hepatic disorders
- Chronic hematological disorders
- Chronic metabolic disorder (including diabetes mellitus and thyroid disorders)
- Immunosuppression (including immunosuppression caused by medications, congenital etiologies or HIV)
- Any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders)
- Residence in nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions
- Household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above
- Employment as a health care worker
Subject is unable to lead an independent life as a result of either physical or mental handicap
Subject has a history of severe allergic reactions or anaphylaxis (e.g., urticaria or asthma that is clinically severe)
Subject has an oral temperature of >= 99.5° F (37.5°C) on the day of vaccination in this study. [NOTE: A subject meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided that certain requirements [in the study protocol] are met)
Subject has a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
Subject has received a blood transfusion, blood products or immunoglobulins within 90 days of study entry
Subject has received a live vaccine within 4 weeks or inactivated or subunit vaccine within 2 weeks of study entry
Subject has previously been vaccinated against influenza for the 2008/2009 northern hemisphere influenza season
Subject has a functional or surgical asplenia
Subject has a known or suspected problem with alcohol or drug abuse;
Subject was administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
Subject is 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, spouse/partner, siblings, parents) as well as employees of the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800605

Show 36 Study Locations

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Baxter Bio Science Investigator, MD

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Karen Near, MD; Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00800605 History of Changes
Other Study ID Numbers:	720802
Study First Received:	December 1, 2008
Last Updated:	October 28, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013