Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

• Sponsor: Ology Bioservices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00782431
• Collaborator: (none)
• Enrollment: 3,195
• Locations: 30
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 106.5
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition [HI] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Vero cell derived, trivalent, seasonal influenza vaccine; Biological: Licensed egg-derived, trivalent seasonal influenza vaccine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 3195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Phase 3 Double Blind Clinical Study of Effectiveness and Safety of Vero Cell-Derived, Trivalent, Seasonal Influenza Vaccine in Adults Aged 50 Years and Older
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Vero cell-derived, trivalent, seasonal influenza vaccine	Biological: Vero cell derived, trivalent, seasonal influenza vaccine; Single intramuscular injection
Active Comparator: 2 Licensed egg-derived, trivalent seasonal influenza vaccine	Biological: Licensed egg-derived, trivalent seasonal influenza vaccine; Single intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Seroconversion at Day 21 after vaccination [21 days]

Secondary Outcome Measures

1. Rate of subjects with seroconversion at Day 21 after vaccination [21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Are 50 years of age or older on the day of screening

• Have an understanding of the study, agree to its provisions, have the ability to adhere to the provisions of the study and give written informed consent prior to study entry

• If female and capable of bearing children,have a negative urine pregnancy test result within 24 hours prior to the vaccination on Study Day 0 and agree to employ adequate birth control measures.

Exclusion Criteria:

• History of severe allergic reaction or anaphylaxis to egg protein or any other component of the Vero cell-derived influenza vaccine or the egg-derived influenza vaccine

• Oral temperature of >= 99.5°F (37.5°C) on the day of vaccination in this study (Note: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date if certain requirements [in the study protocol] are met)

• Rash or dermatologic condition or tattoos which may interfere with injection site reaction rating

• Blood transfusion or immunoglobulins received within 90 days of study entry

• Live vaccine received within 4 weeks or inactivated vaccine or subunit vaccine received within 2 weeks of study entry

• Previous vaccination against influenza for the 2008/2009 northern hemisphere influenza season

• Functional or surgical asplenia (e.g. from a history of hemoglobinopathies, leukemias, or lymphomas)

• Diagnosed immunodeficiency as a result of a pathological condition

• Pharmacologically induced immunodeficiency as a result of prescribed administration of corticosteroids (e.g., any systemic administration of corticosteroids or an inhaled dose equivalent to 800 mg of beclomethasone dipropionate) or chemotherapeutics or as a result of radiation therapy or any other modality capable of altering normal immunologic response

• Known or suspected problem with drug or alcohol abuse

• Investigational drug received within 6 weeks prior to study entry or concurrent participating in a clinical study that includes the administration of an investigational product

• Subjects who 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, spouse/partner, siblings, parents) as well as employees of the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	36608
2	Quality of Life Medical & Research Center, LLC	Tucson	Arizona	United States	85712
3	Benchmark Research, San Francisco	Sacramento	California	United States	95816
4	California Research Foundation	San Diego	California	United States	92103-6204
5	Benchmark Research San Francisco	San Francisco	California	United States	94102
6	Clinical Research of South Florida	Coral Cables	Florida	United States	33134
7	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
8	University Clinical Research, Inc.	Pembrook Pines	Florida	United States	33024
9	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
10	Johnson County Clin-Trials	Lenexa	Kansas	United States	66219
11	Vince and Associates Clinical Research	Overland Park	Kansas	United States	66212
12	Heartland Research Associates, LLC	Wichita	Kansas	United States	67205
13	Heartland Research Associates LLC	Wichita	Kansas	United States	67207
14	Central Kentucky Research Associates, Inc.	Lexington	Kentucky	United States	40509
15	Center for Pharmaceutical Research	Kansas City	Missouri	United States	64114
16	Radiant Research, Inc.	St. Louis	Missouri	United States	63141
17	Sundance Clinical Research	St. Louis	Missouri	United States	63141
18	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
19	Regional Clinical Research, Inc.	Endwell	New York	United States	13760
20	Rochester Clinical Research Inc.	Rochester	New York	United States	14609
21	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
22	Omega Medical Research	Warwick	Rhode Island	United States	02886
23	Palmetto Medical Research	Mt. Pleasant	South Carolina	United States	29464
24	Clinical Research Associates, Inc. - Nashville	Nashville	Tennessee	United States	37203
25	Benchmark Research Austin	Austin	Texas	United States	78705
26	Benchmark Research Ft. Worth	Fort Worth	Texas	United States	76135
27	Research Across America	Plano	Texas	United States	75093
28	Benchmark Research San Angelo	San Angelo	Texas	United States	76904
29	Pi-Coor Clinical Research	Fairfax	Virginia	United States	22030
30	Clinical Research Associates of Tidewater	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Ology Bioservices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00782431
• Other Study ID Numbers: 720801
• First Posted: Oct 31, 2008
• Last Update Posted: Oct 29, 2015
• Last Verified: Oct 1, 2009

• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

No Results Posted as of Oct 29, 2015