InfluenzaPhase 2NCT00845429
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
A Phase 2 study testing Influenza virus vaccine - cell based (2007-2008 Formulation), Influenza virus vaccine - cell-based (2007-2008 Formulation) and Influenza virus vaccine (2007-2008 Formulation) in people with Influenza and Orthomyxoviruses, run by Sanofi at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviruses, Myxovirus Infection
- What is being tested?
- Influenza virus vaccine - cell based (2007-2008 Formulation), Influenza virus vaccine - cell-based (2007-2008 Formulation) and Influenza virus vaccine (2007-2008 Formulation)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 729 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2007to Nov 2008
- Phase
- Phase 2
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Bensalem, Pennsylvania, 19020
Study site
Cary, North Carolina, 27518
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45249
Study site
Hoover, Alabama, 35216
Study site
Kansas City, Missouri, 64114
Study site
Milford, Connecticut, 06460
Study site
Mobile, Alabama, 36608
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Pinellas Park, Florida, 33781
Study site
Raleigh, North Carolina, 27609
Study site
Springfield, Missouri, 65802
Study site
Tucson, Arizona, 85710
Study site
Warwick, Rhode Island, 02886
Study site
Wichita, Kansas, 67207
About this study
Official title: Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years
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
- Influenza, Orthomyxoviruses, Myxovirus Infection
- Being tested
- Influenza virus vaccine - cell based (2007-2008 Formulation), Influenza virus vaccine - cell-based (2007-2008 Formulation), Influenza virus vaccine (2007-2008 Formulation)
- Keywords
- Influenza, Orthomyxoviruses, Split-virion inactivated influenza vaccine, cell-based vaccine, Adults
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza virus vaccine - cell based (2007-2008 Formulation)Biological
0.5 mL, Intramuscular
Influenza virus vaccine - cell-based (2007-2008 Formulation)Biological
1.0 mL, Intramuscular
Influenza virus vaccine (2007-2008 Formulation)Biological
Also called Fluzone® (2007-2008 formulation)
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard-dose Cell-based Influenza Vaccine | Experimental | Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. Receives: Biological: Influenza virus vaccine - cell based (2007-2008 Formulation) |
| Group 2: High-dose Cell-based Influenza Vaccine | Experimental | Participants will receive a single dose of high-dose cell-based influenza virus vaccine. Receives: Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation) |
| Group 3: Licensed Fluzone® Influenza Vaccine | Active comparator | Participants will receive a single dose of licensed Fluzone® influenza vaccine. Receives: Biological: Influenza virus vaccine (2007-2008 Formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
Measured: 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)
Measured: 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.
Measured: Day 21 post-vaccination
Secondary outcomes (1)
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.
Measured: Day 0 up to Day 7 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionNov 2008
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.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845429
- Sponsor's protocol ID
- GCE03
- Status last verified
- Dec 2012
- First submitted
- 13 Feb 2009
- Last updated
- 19 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years
- ClinicalTrials.gov ID
- NCT00845429
- Acronym / sponsor ID
- GCE03
- Conditions
- Influenza, Orthomyxoviruses, Myxovirus Infection
- Keywords
- Influenza, Orthomyxoviruses, Split-virion inactivated influenza vaccine, cell-based vaccine, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 17 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard-dose Cell-based Influenza Vaccine | Experimental | Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)Participants will receive a single dose of standard-dose cell-based influenza virus vaccine. |
| Group 2: High-dose Cell-based Influenza Vaccine | Experimental | Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)Participants will receive a single dose of high-dose cell-based influenza virus vaccine. |
| Group 3: Licensed Fluzone® Influenza Vaccine | Active comparator | Biological: Influenza virus vaccine (2007-2008 Formulation)Participants will receive a single dose of licensed Fluzone® influenza vaccine. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| Influenza virus vaccine - cell based (2007-2008 Formulation)0.5 mL, Intramuscular | Biological | Group 1: Standard-dose Cell-based Influenza Vaccine |
| Influenza virus vaccine - cell-based (2007-2008 Formulation)1.0 mL, Intramuscular | Biological | Group 2: High-dose Cell-based Influenza Vaccine |
| Influenza virus vaccine (2007-2008 Formulation)Also: Fluzone® (2007-2008 formulation)0.5 mL, Intramuscular | Biological | Group 3: Licensed Fluzone® Influenza Vaccine |
Primary outcome
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.
Time frame: Day 21 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)
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Time frame: Day 21 post-vaccination
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.
1 secondary outcome
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
Time frame: Day 0 up to Day 7 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza virus vaccine - cell based (2007-2008 Formulation), Influenza virus vaccine - cell-based (2007-2008 Formulation) and Influenza virus vaccine (2007-2008 Formulation) in people with Influenza and Orthomyxoviruses, run by Sanofi at 15 sites in United States.
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 4 inclusion and 18 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 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Dec 2012). 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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.