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Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01773928
First received: January 17, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process:

  1. induces immune responses comparable to that produced by the current manufacturing process
  2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine
  3. demonstrates consistency of immune response among three different lots.

Condition Intervention Phase
Influenza
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Biological: VCIV manufactured with the current manufacturing process (VCIV current)
Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Hemagglutination inhibition antibody (HIA) titer for each of the three antigens contained in the vaccine [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • Number of participants with fever [ Time Frame: onset within 7 days post vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with seroprotective antibody titer [reciprocal HIA titer ≥40] for each of the three antigens contained in the vaccine [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • Number of participants demonstrating seroconversion to each of the three antigens contained in the vaccine [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer ≥ 40 when there is no detectable HIA titer (reciprocal HIA titer < 10) at baseline

  • Fold increase of HIA titer for each of the three antigens contained in the vaccine as compared to baseline [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • Number of participants with solicited systemic reactions [ Time Frame: within 7 days post-vaccination ] [ Designated as safety issue: Yes ]
  • Number of participants with injection site reactions [ Time Frame: within 7 days post-vaccination ] [ Designated as safety issue: Yes ]
  • Frequency and severity of each solicited systemic reaction and injection site reaction [ Time Frame: within 7 days of vaccination ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: within 21 days post-vaccination ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events [ Time Frame: within 21 days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 1928
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VCIV - Modified manufacturing process (18-49 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Experimental: VCIV - Modified manufacturing process (18-49 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Experimental: VCIV - Modified manufacturing process (18-49 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Active Comparator: VCIV manufactured with current process (18-49 Years Old)
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: VCIV manufactured with the current manufacturing process (VCIV current)
Active Comparator: Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)
Experimental: VCIV - Modified manufacturing process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Experimental: VCIV - Modified manufacturing process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Experimental: VCIV - Modified manufacturing process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Active Comparator: Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is 18 to 49 years of age, inclusive, at the time of screening (for Cohort 18 to 49 years of age);
  • Participant is 50 years of age, inclusive, or older at the time of screening (for Cohort 50 years of age or older);
  • Participant gave written informed consent prior to study entry
  • Participant is generally healthy without any significant medical risk conditions, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination;
  • Participant is willing and able to comply with the requirements of the protocol;
  • Participant agrees to keep a record of symptoms for the duration of the study;
  • If female and capable of bearing children - participant has a negative urine pregnancy test at the study site, within 36 hours prior to vaccination, and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study adequate birth control measures incorporate one of the following FDA approved birth control measures for the duration of the study:

    • Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR
    • A barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Exclusion Criteria:

  • Participant has been vaccinated with seasonal trivalent influenza vaccine in the current season;
  • Participant has an oral temperature of ≥100.4°F (≥38.0°C) on the day of vaccination in this study;
  • Participant has received a live vaccine within 4 weeks, or an inactivated or subunit vaccine within 2 weeks of study entry;
  • Participant with a known history of infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAgs) or Hepatitis C Virus (HCV);
  • Participant has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the Investigator;
  • Participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids (> 800 μg/day of beclomethasone dipropionate or equivalent), radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted);
  • Participant has a known history of Guillain Barré Syndrome, demyelinating disorders (including acute demyelinating encephalomyelitis (ADEM), Multiple Sclerosis) or convulsions;
  • Participant has a history of severe allergic reactions or anaphylaxis as determined by the Investigator;
  • Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the Investigator;
  • Participant has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry;
  • Participant has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry;
  • Participant has a functional or surgical asplenia;
  • Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
  • Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the Investigator or study site personnel conducting the study;
  • If female, participant is pregnant or lactating at the time of study enrollment;
  • Participant is currently enrolled or has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study;
  • Participant has any condition that in the opinion of the Investigator would interfere with evaluation of the vaccine or interpretation of study results.
  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: NCT01773928

Locations
United States, Arizona
East Valley Family Physicians, PLC
Chandler, Arizona, United States, 85224
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Center for Clinical Trials, LLC
Paramount, California, United States, 90723
California Research Foundation
San Diego, California, United States, 92103
Benchmark Research San Francisco
San Francisco, California, United States, 94102
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Avail Clinical Research, LLC
Deland, Florida, United States, 32720
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Missouri
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States, 64114
Sundance Clinical Research, LLC
St. Louis, Missouri, United States, 63141
United States, New York
Rochester Clinical Research Inc.
Rochester, New York, United States, 14609
United States, North Carolina
PMG Research of Cary, LLC
Cary, North Carolina, United States, 27518
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Benchmark Research Austin
Austin, Texas, United States, 78705
Benchmark Research
Fort Worth, Texas, United States, 76135
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Nirjhar Chatterjee, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01773928     History of Changes
Other Study ID Numbers: 721104
Study First Received: January 17, 2013
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
Active immunization against influenza disease

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