CompletedNCT00845429Updated Dec 19, 2012Results posted

Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

A Phase 2 interventional study of Influenza virus vaccine - cell based (2007-2008 Formulation) and Influenza virus vaccine - cell-based (2007-2008 Formulation) in Influenza, Orthomyxoviruses and Myxovirus Infection, sponsored by Sanofi. Completed at 15 sites in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-19.

Sponsored by Sanofi · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 729
Allocation: Randomized
Ages: 18 Years to 49 Years
Sex: All

Study summary

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Read the detailed description

This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Conditions studied

Influenza
Orthomyxoviruses
Myxovirus Infection

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Orthomyxoviruses
Split-virion inactivated influenza vaccine
cell-based vaccine
Adults

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 729 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 49 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male or female subject, aged ≥ 18 to \< 50 years on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination

Exclusion criteria

Exclusion Criteria :

Subject currently breast-feeding.
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids
Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
Receipt of blood or blood-derived products in the 3 months preceding vaccination.
Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
Planned receipt of any other 2007-2008 influenza vaccine.
Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
History of Guillain-Barré syndrome
Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 729 participants (actual)

Study arms

Experimental
Group 1: Standard-dose Cell-based Influenza Vaccine
Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
Experimental
Group 2: High-dose Cell-based Influenza Vaccine
Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
Active comparator
Group 3: Licensed Fluzone® Influenza Vaccine
Participants will receive a single dose of licensed Fluzone® influenza vaccine.
Biological: Influenza virus vaccine (2007-2008 Formulation)

Interventions

BiologicalInfluenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
BiologicalInfluenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
BiologicalInfluenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Also known as: Fluzone® (2007-2008 formulation)

What researchers measure

Primary outcomes

Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Time frame: Days 0 and 21 post-vaccination
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Time frame: Day 21 post-vaccination
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Time frame: Day 21 post-vaccination

Secondary outcomes

Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
Time frame: Day 0 up to Day 7 post-vaccination

Results

Posted Dec 17, 2012

Participant flow

Participants were enrolled from 16 to 23 October 2007 in 15 clinical centers in the US.

Participant flow — Overall Study
Milestone	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
Started	244	241	244
Completed	230	226	224
Not completed	14	15	20
Withdrew: Protocol violation	5	4	7
Withdrew: Lost to follow-up	7	9	10
Withdrew: Withdrawal by subject	2	2	2
Withdrew: Serious adverse event	0	0	1

Outcome measures

PrimarySummary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.

Time frame:: Days 0 and 21 post-vaccination
Reported as:: Geometric mean · Titers

Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Titers	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
A/H1N1: Solomon Islands, Day 0 (N = 236, 231, 237)	25.9 (21.0 to 32.0)	26.4 (21.6 to 32.4)	26.6 (21.7 to 32.5)
A/H1N1: Solomon Islands, Day 21 (N= 236, 232, 238)	184.8 (150.1 to 227.5)	226.6 (187.2 to 274.4)	425.1 (357.2 to 505.9)
A/H3N2: Wisconsin, Day 0 (N = 236, 232, 237)	51.2 (41.2 to 63.6)	53.4 (43.8 to 65.2)	51.5 (41.4 to 64.0)
A/H3N2: Wisconsin, Day 21 (N = 236, 230, 238)	288.3 (243.1 to 342.0)	351.3 (302.2 to 408.5)	692.4 (596.3 to 803.9)
B: Malaysia, Day 0 (N = 236, 233, 238)	13.4 (11.8 to 15.1)	14.3 (12.6 to 16.3)	14.2 (12.5 to 16.2)
B: Malaysia, Day 21 (nN= 235, 233, 237)	51.1 (43.2 to 60.4)	53.0 (45.6 to 61.6)	108.6 (95.4 to 123.7)

PrimaryPercentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.

Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)

Time frame:: Day 21 post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
Percentage of Participants	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
A/H1N1: Solomon Islands Day 0 (N = 236, 231, 237)	40	39	41
A/H1N1: Solomon Islands Day 21 (N = 236, 232, 238)	86	90	98
A/H3N2: Wisconsin Day 0 (N = 236, 232, 237)	54	62	55
A/H3N2: Wisconsin Day 21 (N = 236, 230, 238)	94	98	99
B: Malaysia Day 0 (N = 236, 233, 238)	14	20	20
B: Malaysia Day 21 (N = 235, 233, 237)	60	64	87

PrimaryPercentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.

Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.

Time frame:: Day 21 post-vaccination
Reported as:: Number · Percentage of Participants

Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Percentage of Participants	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
A/H1N1: Solomon Islands (N = 236, 231, 237)	54	63	74
A/H3N2: Wisconsin (N = 236, 230, 237)	50	53	71
B: Malaysia (N = 235, 233, 237)	38	38	61

SecondaryNumber of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.

Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.

Time frame:: Day 0 up to Day 7 post-vaccination
Reported as:: Number · Participants

Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Participants	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
Any Solicited Injection Site Reaction	117	156	184
Any Pain	103	144	175
Grade 3 Pain (incapacitating, prevents activities)	1	2	1
Any Erythema	36	57	55
Grade 3 Erythema (≥ 5 cm)	0	0	4
Any Swelling	24	23	36
Grade 3 Swelling (≥ 5 cm)	0	0	1
Any Ecchymosis	6	19	14
Grade 3 Ecchymosis (≥ 5 cm)	0	0	1
Any Induration	31	29	38
Grade 3 Induration (≥ 5 cm)	0	0	0
Any Solicited Systemic Reaction	114	126	137
Any Fever	13	9	11
Grade 3 Fever (39.0 ºC or 102.2 ºF)	0	0	2
Any Headache	75	85	89
Grade 3 Headache (Prevents daily activities)	3	3	6
Any Malaise	58	54	63
Grade 3 Malaise (Prevents daily activities)	6	4	5
Any Myalgia	60	70	83
Grade 3 Myalgia (Prevents daily activities)	1	3	4
Any Rigors	16	9	13
Grade 3 Rigors (Prevents daily activities)	2	1	1

Adverse events

Collected over Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post-vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1: Standard Dose Cell-Based Influenza Vaccine	—	3/244 (1.2%)	158/244 (64.8%)
Group 2: High-dose Cell-Based Influenza Vaccine	—	4/241 (1.7%)	179/241 (74.3%)
Group 3: Licensed Fluzone® Influenza Vaccine	—	6/244 (2.5%)	199/244 (81.6%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
Gallbladder Non-functioningHepatobiliary disorders	0/244	1/241	0/244
Gastrointestinal Stoma ComplicationInjury, poisoning and procedural complications	0/244	1/241	0/244
Tibia FractureInjury, poisoning and procedural complications	0/244	1/241	0/244
Abortion SpontaneousPregnancy, puerperium and perinatal conditions	0/244	1/241	0/244
NephrolithiasisRenal and urinary disorders	0/244	1/241	0/244
Biliary DyskinesiaHepatobiliary disorders	0/244	0/241	1/244
DiverticulitisInfections and infestations	1/244	0/241	0/244
GastroenteritisInfections and infestations	1/244	0/241	1/244
Pelvic FractureInjury, poisoning and procedural complications	0/244	0/241	1/244
DehydrationMetabolism and nutrition disorders	1/244	0/241	0/244

Most frequent other events

Most frequent other events
Event	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine
Injection site PainGeneral disorders	103/240	144/234	175/238
HeadacheNervous system disorders	75/240	85/234	89/238
MyalgiaMusculoskeletal and connective tissue disorders	60/240	70/234	83/238
MalaiseGeneral disorders	58/240	54/234	63/238
Injection site ErythemaGeneral disorders	36/240	57/234	55/238
Injection site IndurationGeneral disorders	31/240	29/234	38/238
Injection site SwellingGeneral disorders	24/240	23/234	36/238
Injection site EcchymosisGeneral disorders	6/240	19/234	14/238
RigorsGeneral disorders	16/240	9/234	13/238
FeverGeneral disorders	13/240	9/234	11/238

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine	Total
<=18 years	0	0	0	0
Between 18 and 65 years	244	241	244	729
>=65 years	0	0	0	0

Age Continuous
Age Continuous(Years)	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine	Total
Mean	34.4 ± 9.41	34.5 ± 9.18	34.1 ± 9.42	34.3 ± 9.32

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine	Total
Female	158	162	151	471
Male	86	79	93	258

Region of Enrollment
Region of Enrollment(participants)	Group 1: Standard Dose Cell-Based Influenza Vaccine	Group 2: High-dose Cell-Based Influenza Vaccine	Group 3: Licensed Fluzone® Influenza Vaccine	Total
United States	244	241	244	729

Study locations

15 sites

Hoover, Alabama 35216, United States
Mobile, Alabama 36608, United States
Tucson, Arizona 85710, United States
Milford, Connecticut 06460, United States
Pinellas Park, Florida 33781, United States
Chicago, Illinois 60610, United States
Wichita, Kansas 67207, United States
Kansas City, Missouri 64114, United States
Springfield, Missouri 65802, United States
Cary, North Carolina 27518, United States
Raleigh, North Carolina 27609, United States
Cincinnati, Ohio 45249, United States
Bensalem, Pennsylvania 19020, United States
Warwick, Rhode Island 02886, United States
Mt Pleasant, South Carolina 29464, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00845429
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Feb 18, 2009
Start date: Oct 2007
Primary completion: Aug 2008
Completion: Nov 2008
Results posted: Dec 17, 2012
Last update: Dec 19, 2012

Study contacts

Medical Director

study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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