Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
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
1 other identifier
interventional
1,928
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
September 11, 2025
CompletedSeptember 11, 2025
August 1, 2025
3 months
January 17, 2013
October 7, 2015
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
21 days post vaccination
Non-inferiority of Modified Manufacturing Process Compared to the Current Process
Non-inferiority of modified manufacturing process compared to the current process. Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process
21 days post vaccination
Lot Consistency of the Three Modified Manufacturing Process Lots
Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process.
21 days post vaccination
Percentage of Participants With Fever
Percentage of participants with fever
onset within 7 days post vaccination
Secondary Outcomes (8)
Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
21 days post vaccination
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
21 days post vaccination
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
21 days post vaccination
Percentage of Participants With Solicited Systemic Reactions
within 7 days post vaccination
Percentage of Participants With Injection Site Reactions
within 7 days post vaccination
- +3 more secondary outcomes
Study Arms (9)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 1
EXPERIMENTALVero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 2
EXPERIMENTALVero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 3
EXPERIMENTALVero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with current process (18-49 Years Old)
ACTIVE COMPARATORVero cell-derived trivalent influenza vaccine (VCIV)
Fluzone® (18-49 Years Old)
ACTIVE COMPARATORFluzone®, licensed trivalent influenza vaccine (TIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 1
EXPERIMENTALVero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 2
EXPERIMENTALVero cell-derived trivalent influenza vaccine (VCIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 3
EXPERIMENTALVero cell-derived trivalent influenza vaccine (VCIV)
Fluzone® (≥50 Years Old)
ACTIVE COMPARATORFluzone®, licensed trivalent influenza vaccine (TIV)
Interventions
Eligibility Criteria
You may qualify if:
- 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.).
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
California Research Foundation
San Diego, California, 92103, United States
Benchmark Research San Francisco
San Francisco, California, 94102, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Rochester Clinical Research Inc.
Rochester, New York, 14609, United States
PMG Research of Cary, LLC
Cary, North Carolina, 27518, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Benchmark Research Austin
Austin, Texas, 78705, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angie Kimbler
- Organization
- Alachua Government Services, Inc.
Study Officials
- STUDY DIRECTOR
Nirjhar Chatterjee, MD
Baxter Healthcare Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 23, 2013
Study Start
January 1, 2013
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 11, 2025
Results First Posted
September 11, 2025
Record last verified: 2025-08