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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00566345
First received: November 30, 2007
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Influenza
Biological: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)
Biological: 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 (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens [ Time Frame: 21 days to 180 days after the date of vaccination ] [ Designated as safety issue: No ]
  • Consistency of immune response produced by 3 different lots of VCIV [ Time Frame: Through Day 180 after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of occurrence of any injection site reactions and systemic reactions/adverse events related to vaccination [ Time Frame: During the entire 180-day follow-up period ] [ Designated as safety issue: Yes ]

Enrollment: 3670
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566345

  Show 35 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Karen Near, MD Baxter Healthcare Corporation
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie McLaren, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00566345     History of Changes
Other Study ID Numbers: 720703
Study First Received: November 30, 2007
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014