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

September 22, 2023 updated by: Ology Bioservices

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3670

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Anaheim, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Florida
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Pembroke Pines, Florida, United States
      • South Miami, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kansas
      • Lenexa, Kansas, United States
      • Overland Park, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maryland
      • Columbia, Maryland, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • South Carolina
      • Goose Creek, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • 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
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Influenza vaccine
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: Placebo
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Other: Phosphate buffered saline
Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
21 days to 180 days after the date of vaccination
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values
Time Frame: 21 Days after vaccination
Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.
21 Days after vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
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
During the entire 180-day follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ology Bioservices

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimated)

December 3, 2007

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 720703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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