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

Phase 3

Completed

Conditions: Influenza

Interventions: 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)

Registration Number: NCT01773928

Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1928

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VCIV - Modified manufacturing process (18-49 Years Old) Lot 1	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 2	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 3	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with current process (18-49 Years Old)	VCIV manufactured with the current manufacturing process (VCIV current)	Vero cell-derived trivalent influenza vaccine (VCIV)
Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV)	Fluzone®, licensed trivalent influenza vaccine (TIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 1	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 2	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 3	Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Vero cell-derived trivalent influenza vaccine (VCIV)
Fluzone® (≥50 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV)	Fluzone®, licensed trivalent influenza vaccine (TIV)

Primary Outcome Measures

Name	Time	Method
Hemagglutination inhibition antibody (HIA) titer for each of the three antigens contained in the vaccine	21 days post-vaccination
Number of participants with fever	onset within 7 days post vaccination

Secondary Outcome Measures

Name	Time	Method
Number of participants with seroprotective antibody titer [reciprocal HIA titer ≥40] for each of the three antigens contained in the vaccine	21 days post-vaccination
Number of participants demonstrating seroconversion to each of the three antigens contained in the vaccine	21 days post-vaccination	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	21 days post-vaccination
Number of participants with solicited systemic reactions	within 7 days post-vaccination
Number of participants with injection site reactions	within 7 days post-vaccination
Frequency and severity of each solicited systemic reaction and injection site reaction	within 7 days of vaccination
Number of participants with adverse events	within 21 days post-vaccination
Frequency and severity of adverse events	within 21 days post-vaccination

Trial Locations

Locations (20): Spartanburg Medical Research
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Spartanburg, South Carolina, United States
East Valley Family Physicians, PLC
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Chandler, Arizona, United States
PMG Research of Cary, LLC
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Cary, North Carolina, United States
Avail Clinical Research, LLC
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Deland, Florida, United States
Jean Brown Research
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Salt Lake City, Utah, United States
Miami Research Associates
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South Miami, Florida, United States
Benchmark Research
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Fort Worth, Texas, United States
California Research Foundation
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San Diego, California, United States
Center for Clinical Trials, LLC
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Paramount, California, United States
Anaheim Clinical Trials
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Anaheim, California, United States
Clinical Research of South Florida
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Coral Gables, Florida, United States
The Center for Pharmaceutical Research, P.C.
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Kansas City, Missouri, United States
Benchmark Research San Francisco
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San Francisco, California, United States
Wake Research Associates, LLC
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Raleigh, North Carolina, United States
Benchmark Research Austin
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Austin, Texas, United States
Clinical Research Atlanta
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Stockbridge, Georgia, United States
Sundance Clinical Research, LLC
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St. Louis, Missouri, United States
Heartland Research Associates, LLC
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Wichita, Kansas, United States
Rapid Medical Research, Inc.
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Cleveland, Ohio, United States
Rochester Clinical Research Inc.
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Rochester, New York, United States