Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00566345
• Collaborator: (none)
• Enrollment: 3,670
• Locations: 35
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 104.9
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived); Biological: Phosphate buffered saline	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 3670 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Vero-cell derived influenza vaccine	Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived); Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
Placebo Comparator: 2 Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)	Biological: Phosphate buffered saline; Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Outcome Measures

Primary Outcome Measures

1. Number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens [21 days to 180 days after the date of vaccination]

2. Consistency of immune response produced by 3 different lots of VCIV [Through Day 180 after vaccination]

Secondary Outcome Measures

1. Frequency and severity of occurrence of any injection site reactions and systemic reactions/adverse events related to vaccination [During the entire 180-day follow-up period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Male and female subjects who

• are 18 to 49 years of age, inclusive, on the day of screening

• have an understanding of the study, agree to its provisions 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 of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination: hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Exclusion Criteria:

Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):

• 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)

• immunosuppression (including immunosuppression caused by medications 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 a 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

Subjects are also excluded if they

• are unable to lead an independent life as a result of either physical or mental handicap

• have a history of severe allergic reactions or anaphylaxis

• have an 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 provided: 1.) oral temperature has decreased to < 99.5°F (37.5°C) on rescheduled date, 2.) all other inclusion/exclusion criteria are met, 3.) the rescheduled date is no more than 14 days past the initial screening date, 4.) the study site is still enrolling subjects]

• have a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating

• have received a blood transfusion or immunoglobulins within 90 days of study entry

• have received a live vaccine within 4 weeks or inactivated vaccine within 2 weeks of study entry

• have previously been vaccinated against influenza for the 2007/2008 northern hemisphere influenza season

• have functional or surgical asplenia

• have a known or suspected problem with alcohol or drug abuse

• were 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

• 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	Radiant Research Tucson	Tuscon	Arizona	United States	85710
2	Advanced Clinical Research Institute	Anaheim	California	United States	92801
3	Orange County Clinical Research, Inc.	Cypress	California	United States	90630
4	Benchmark Research	Sacramento	California	United States	95816
5	California Research Foundation	San Diego	California	United States	92103-6204
6	Benchmark Research San Francisco	San Francisco	California	United States	94102
7	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
8	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
9	Miami Research Associates	Miami	Florida	United States	33143
10	University Clinical Research, Inc.	Pembroke	Florida	United States	33024
11	Radiant Research Inc. - Chicago	Chicago	Illinois	United States	60610
12	PRA International Clinical Pharmacology Center	Lenexa	Kansas	United States	66219
13	Vince and Associates Clinical Research	Overland Park	Kansas	United States	66212
14	Central Kentucky Research Associates, Inc.	Lexington	Kentucky	United States	40509
15	Benchmark Research	Metairie	Louisiana	United States	70006
16	Columbia Medical Practice	Columbia	Maryland	United States	21045
17	Center for Pharmaceutical Research	Kansas City	Missouri	United States	64114
18	Sundance Clinical Research	St. Louis	Missouri	United States	63141
19	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
20	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89130
21	Rochester Clinical Research	Rochester	New York	United States	14609
22	Metrolina Medical Research	Charlotte	North Carolina	United States	28209
23	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
24	Piedmont Medical Research Associates	Winston-Salem	North Carolina	United States	27103
25	Coastal Carolina Research Center	Goose Creek	South Carolina	United States	29445
26	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
27	Clinical Research Associates, Inc. - Nashville	Nashville	Tennessee	United States	37203
28	Benchmark Research Austin	Austin	Texas	United States	78705
29	Research Across America - CNS Research Group	Dallas	Texas	United States	75234
30	Benchmark Research Ft. Worth	Ft. Worth	Texas	United States	76135
31	Research Across America - CNS Research Group	Plano	Texas	United States	75093
32	Benchmark Research San Angelo	San Angelo	Texas	United States	76904
33	Radiant Research - San Antonio Northeast	San Antonio	Texas	United States	78217
34	Jean Brown Associates, Inc.	Salt Lake City	Utah	United States	84124
35	Clinical Research Associates of Tidewater	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Baxter Healthcare Corporation

Investigators

• Study Director: Karen Near, MD, Baxter Healthcare Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00566345
• Other Study ID Numbers: 720703
• First Posted: Dec 3, 2007
• Last Update Posted: Aug 10, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Aug 10, 2009