Clinical trial NCT01773928: Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Active immunization against influenza disease
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 1928
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Hemagglutination inhibition antibody (HIA) titer for each of the three antigens contained in the vaccine
timeFrame: 21 days post-vaccination
measure: Number of participants with fever
timeFrame: onset within 7 days post vaccination
Secondary outcomes:
measure: Number of participants with seroprotective antibody titer [reciprocal HIA titer ≥40] for each of the three antigens contained in the vaccine
timeFrame: 21 days post-vaccination
measure: Number of participants demonstrating seroconversion to each of the three antigens contained in the vaccine
timeFrame: 21 days post-vaccination
measure: Fold increase of HIA titer for each of the three antigens contained in the vaccine as compared to baseline
timeFrame: 21 days post-vaccination
measure: Number of participants with solicited systemic reactions
timeFrame: within 7 days post-vaccination
measure: Number of participants with injection site reactions
timeFrame: within 7 days post-vaccination
measure: Frequency and severity of each solicited systemic reaction and injection site reaction
timeFrame: within 7 days of vaccination
measure: Number of participants with adverse events
timeFrame: within 21 days post-vaccination
measure: Frequency and severity of adverse events
timeFrame: within 21 days post-vaccination
Other outcomes:
Locations:
city: Chandler
country: United States
facility: East Valley Family Physicians, PLC
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Francisco
country: United States
facility: Benchmark Research San Francisco
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: St. Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research Inc.
state: New York
city: Cary
country: United States
facility: PMG Research of Cary, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research Austin
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Baxter Healthcare Corporation
name: Nirjhar Chatterjee, MD
role: STUDY_DIRECTOR
References:
citation: StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.