InfluenzaPhase 3NCT01773928

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

A Phase 3 study testing Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified), VCIV manufactured with the current manufacturing process (VCIV current) and Fluzone®, licensed trivalent influenza vaccine (TIV) in people with Influenza, run by Alachua Government Services, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified), VCIV manufactured with the current manufacturing process (VCIV current) and Fluzone®, licensed trivalent influenza vaccine (TIV)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,928 participants
Where: 20 sitesUnited States
Study dates: Jan 2013to Apr 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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.).

Who cannot join

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);

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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.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

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

Other trials in United States

About this study

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

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

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

Conditions: Influenza
Being tested: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified), VCIV manufactured with the current manufacturing process (VCIV current), Fluzone®, licensed trivalent influenza vaccine (TIV)
Keywords: Active immunization against influenza disease
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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)Biological

Study groups in NCT01773928
Study group	Role	What they receive
VCIV - Modified manufacturing process (18-49 Years Old) Lot 1	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 2	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 3	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV manufactured with current process (18-49 Years Old)	Active comparator	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: VCIV manufactured with the current manufacturing process (VCIV current)
Fluzone® (18-49 Years Old)	Active comparator	Fluzone®, licensed trivalent influenza vaccine (TIV) Receives: Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 1	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 2	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 3	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV) Receives: Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
Fluzone® (≥50 Years Old)	Active comparator	Fluzone®, licensed trivalent influenza vaccine (TIV) Receives: Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 21 days post vaccination
Percentage of Participants With Fever
Percentage of participants with fever
Measured: onset within 7 days post vaccination

Secondary outcomes (8)

Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Percentage of participants with seroprotective antibody titer [reciprocal HIA titer ≥40] for each of the three antigens contained in the vaccine
Measured: 21 days post vaccination
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
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
Measured: 21 days post vaccination
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
Measured: 21 days post vaccination
Percentage of Participants With Solicited Systemic Reactions
Measured: within 7 days post vaccination
Percentage of Participants With Injection Site Reactions
Measured: within 7 days post vaccination
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Measured: within 7 days post vaccination
Percentage of Participants With Adverse Events
Measured: within 21 days post vaccination
Frequency and Severity of Related Adverse Events
Frequency and severity of adverse events considered related to the vaccination (possibly related, probably related, unknown) according to System Organ Class (SOC) and Preferred Term (PT) SOCs are abbreviated as follows:- BLD- Blood and lymphatic system disorders EAR- Ear and labyrinth disorders EYE- Eye disorders GID- Gastrointestinal disorders GEN- General disorders and administration site conditions IMM- Immune system disorders INF- Infections and infestations MET- Metabolism and nutrition disorders MSK- Musculoskeletal and connective tissue disorders NER- Nervous system disorders RES- Respiratory, thoracic and mediastinal disorders SKN- Skin and subcutaneous tissue disorders VAS- Vascular disorders
SYS-Systemic LOC-Local
Measured: within 21 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Apr 2013

First posted23 Jan 2013 (estimated)
Study startJan 2013
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,928 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01773928
Sponsor's protocol ID: 721104
Status last verified: Aug 2025
First submitted: 17 Jan 2013
Last updated: 11 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01773928
Acronym / sponsor ID: 721104
Conditions: Influenza
Keywords: Active immunization against influenza disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,928 participants (actual)
Lead sponsor: Alachua Government Services, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 23 Jan 2013 (estimated)
Results: Posted 11 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
VCIV - Modified manufacturing process (18-49 Years Old) Lot 1	Experimental	Biological: 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	Experimental	Biological: 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	Experimental	Biological: 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)	Active comparator	Biological: VCIV manufactured with the current manufacturing process (VCIV current)Vero cell-derived trivalent influenza vaccine (VCIV)
Fluzone® (18-49 Years Old)	Active comparator	Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)Fluzone®, licensed trivalent influenza vaccine (TIV)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 1	Experimental	Biological: 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	Experimental	Biological: 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	Experimental	Biological: 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)	Active comparator	Biological: Fluzone®, licensed trivalent influenza vaccine (TIV)Fluzone®, licensed trivalent influenza vaccine (TIV)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Time frame: 21 days post vaccination
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
Non-inferiority of Modified Manufacturing Process Compared to the Current Process
Time frame: 21 days post vaccination
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
Lot Consistency of the Three Modified Manufacturing Process Lots
Time frame: 21 days post vaccination
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.
Percentage of Participants With Fever
Time frame: onset within 7 days post vaccination
Percentage of participants with fever

8 secondary outcomes

Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Time frame: 21 days post vaccination
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
Time frame: 21 days post vaccination
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
Percentage of Participants With Solicited Systemic Reactions
Time frame: within 7 days post vaccination
Percentage of Participants With Injection Site Reactions
Time frame: within 7 days post vaccination
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Time frame: within 7 days post vaccination
Percentage of Participants With Adverse Events
Time frame: within 21 days post vaccination
Frequency and Severity of Related Adverse Events
Time frame: within 21 days post vaccination

Results and safety

Results posted to the registry on 11 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluzone® (18-49 Years Old)	201	196
VCIV Current Process (18-49 Years Old)	201	196
VCIV - Modified Process (18-49 Years Old) Lot 1	200	196
VCIV - Modified Process (18-49 Years Old) Lot 2	200	194
VCIV - Modified Process (18-49 Years Old) Lot 3	200	192
Fluzone® (≥50 Years Old)	204	202
VCIV - Modified Process (≥50 Years Old) Lot 1	199	199
VCIV - Modified Process (≥50 Years Old) Lot 2	197	196
VCIV - Modified Process (≥50 Years Old) Lot 3	199	197

Primary outcome: Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine

Time frame: 21 days post vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 n = 196	VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 n = 193	VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 n = 192	Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 n = 581	VCIV Manufactured With Current Process (18-49 Years Old) n = 195	Fluzone® (18-49 Years Old) n = 196	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 n = 199	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 n = 196	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 n = 195	Total VCIV - Modified Process (≥50 Years Old) Lots 1-3 n = 590	Fluzone® (≥50 Years Old) n = 200
Strain A/H1N1	269.7 (222.6 to 326.8)	337.3 (286.9 to 396.6)	288.5 (238.8 to 348.6)	297.1 (267.6 to 329.8)	264.4 (216.0 to 323.7)	595.6 (516.9 to 686.3)	141.3 (113.6 to 175.7)	118.3 (93.9 to 149.1)	112.8 (89.8 to 141.7)	123.7 (108.6 to 140.8)	306.3 (255.5 to 367.1)
Strain A/H3N2	153.5 (127.5 to 184.9)	245.3 (207.1 to 290.6)	205.5 (171.1 to 246.8)	197.5 (178.0 to 219.3)	172.2 (144.2 to 205.6)	314.4 (268.7 to 367.9)	174.4 (143.6 to 211.7)	165.8 (134.3 to 204.6)	168.4 (135.2 to 209.6)	169.5 (150.4 to 191.0)	294.8 (246.7 to 352.3)
Strain B	86.8 (74.5 to 101.0)	83.5 (70.7 to 98.6)	83.6 (70.3 to 99.5)	84.6 (77.0 to 93.0)	60.7 (51.2 to 72.0)	97.3 (84.3 to 112.2)	40.5 (33.4 to 49.0)	35.9 (29.7 to 43.4)	30.4 (25.3 to 36.4)	35.4 (31.7 to 39.4)	37.1 (31.4 to 44.0)

Population analysed: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.

Primary outcome: Non-inferiority of Modified Manufacturing Process Compared to the Current Process

Time frame: 21 days post vaccination. Geometric mean (95% Confidence Interval). Unit: ratio of Geometric Mean- no units

Measure	Strain A/H1N1 n = 774	Strain A/H3N2 n = 774	Strain B n = 774
Value	1.12 (0.93 to 1.35)	1.16 (0.97 to 1.38)	1.33 (1.11 to 1.60)

Strain A/H1N1 vs Strain A/H3N2 vs Strain B: ANCOVA: 0.67

Population analysed: Subset of the per-protocol (PP) analysis dataset of Cohort 1 (18-49 years) comprising subjects from the VCIV modified and VCIV current treatment groups (because the aim of the analysis was to show non-inferiority between the two VCIV manufacturing processes), for all three strains separately.

Primary outcome: Lot Consistency of the Three Modified Manufacturing Process Lots

Time frame: 21 days post vaccination. Geometric mean (95% Confidence Interval). Unit: ratio of geometric mean- no units

Measure	Strain A/H1N1 n = 1163	Strain A/H3N2 n = 1163	Strain B n = 1163
Lot 2 vs. Lot 1	1.00 (0.84 to 1.19)	1.15 (0.98 to 1.35)	0.87 (0.74 to 1.03)
Lot 3 vs. Lot 1	0.90 (0.76 to 1.07)	1.17 (1.00 to 1.38)	0.84 (0.71 to 0.99)
Lot 3 vs. Lot 2	0.89 (0.75 to 1.06)	1.02 (0.87 to 1.20)	0.96 (0.81 to 1.13)

Strain A/H1N1 vs Strain A/H3N2 vs Strain B: ANCOVA: 0.67 (95% CI 0.67 to 1.5)

Population analysed: Subset of the PP analysis dataset comprising the 3 VCIV modified lots (as the aim of the analysis was to show similarity between three different lots of the VCIV manufactured with the modified process), both cohort pooled, for all three strains separately.

Primary outcome: Percentage of Participants With Fever

Time frame: onset within 7 days post vaccination. Number (95% Confidence Interval). Unit: percentage of participants with fever

Measure	VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 n = 200	VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 n = 199	VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 n = 199	Total VCIV - Modified Manufacturing Process (18-49 Years Old) Lots 1-3 n = 598	VCIV Manufactured With Current Process (18-49 Years Old) n = 201	Fluzone® (18-49 Years Old) n = 201	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 n = 199	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 n = 197	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 n = 198	VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1-3 n = 594	Fluzone® (≥50 Years Old) n = 203
Value	2.5 (0.8 to 5.7)	1.0 (0.1 to 3.6)	2.0 (0.6 to 5.1)	1.8 (0.9 to 3.3)	1.0 (0.1 to 3.5)	0.0 (0.0 to 1.8)	2.5 (0.8 to 5.8)	1.0 (0.1 to 3.6)	2.0 (0.6 to 5.1)	1.9 (0.9 to 3.3)	0.0 (0.0 to 1.8)

Total VCIV - Modified Manufacturing Process (18-49 Years Old) Lots 1-3 vs Fluzone® (18-49 Years Old): Method of Miettinen & Nurminen: 1.8 (95% CI 0.1 to 3.3)

Population analysed: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period of approximately 2.5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1	1 of 200 (0.5%)	133 of 200 (66.5%)	0 of 200
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2	0 of 199 (0%)	124 of 199 (62.3%)	0 of 199
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3	0 of 199 (0%)	120 of 199 (60.3%)	0 of 199
VCIV Manufactured With Current Process	0 of 201 (0%)	132 of 201 (65.7%)	0 of 201
Fluzone® (18-49 Years Old)	0 of 201 (0%)	125 of 201 (62.2%)	0 of 201
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1	1 of 199 (0.5%)	97 of 199 (48.7%)	0 of 199
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2	1 of 197 (0.5%)	84 of 197 (42.6%)	0 of 197
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3	2 of 198 (1%)	96 of 198 (48.5%)	0 of 198
Fluzone® (≥50 Years Old)	0 of 203 (0%)	100 of 203 (49.3%)	0 of 203

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundStatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nirjhar Chatterjee, MD study director

Baxter Healthcare Corporation

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine (time frame: 21 days post vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01773928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.