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

NCT ID: NCT00566345

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3670 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-06-30

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Influenza vaccine

Vero-cell derived influenza vaccine

Group Type: EXPERIMENTAL

Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)

Intervention Type: BIOLOGICAL

Trivalent, non-adjuvanted vaccine; dose: 0.5 ml

Placebo

Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)

Group Type: PLACEBO_COMPARATOR

Phosphate buffered saline

Intervention Type: OTHER

Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Interventions

Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)

Trivalent, non-adjuvanted vaccine; dose: 0.5 ml

Intervention Type: BIOLOGICAL

Phosphate buffered saline

Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Intervention Type: OTHER

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Near, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Tucson, Arizona, United States

Anaheim, California, United States

Sacramento, California, United States

San Diego, California, United States

San Francisco, California, United States

Clearwater, Florida, United States

Jacksonville, Florida, United States

Pembroke Pines, Florida, United States

South Miami, Florida, United States

Chicago, Illinois, United States

Lenexa, Kansas, United States

Overland Park, Kansas, United States

Lexington, Kentucky, United States

Metairie, Louisiana, United States

Columbia, Maryland, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Goose Creek, South Carolina, United States

Spartanburg, South Carolina, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Plano, Texas, United States

San Angelo, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Countries

United States

References

Ehrlich HJ, Singer J, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Portsmouth D, Kistner O, Barrett PN. A cell culture-derived influenza vaccine provides consistent protection against infection and reduces the duration and severity of disease in infected individuals. Clin Infect Dis. 2012 Apr;54(7):946-54. doi: 10.1093/cid/cir959. Epub 2012 Jan 19.

Reference Type: DERIVED

PMID: 22267715 (View on PubMed)

Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13.

Reference Type: DERIVED

PMID: 22172502 (View on PubMed)

Barrett PN, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Kistner O, Ehrlich HJ. Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2011 Feb 26;377(9767):751-9. doi: 10.1016/S0140-6736(10)62228-3. Epub 2011 Feb 15.

Reference Type: DERIVED

PMID: 21329971 (View on PubMed)

Other Identifiers

720703

Identifier Type: -

Identifier Source: org_study_id