InfluenzaPhase 4NCT01691339
Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.
A Phase 4 study testing Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation, Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation and Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 sites in United States.
Trial summary
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). 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?
- Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation, Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation and Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2012to Feb 2013
- Phase
- Phase 4
- 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
- Subject is ≥ 18 years of age on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- History of serious adverse reaction to any influenza vaccine
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
- Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
- Prior vaccination with any 2012 - 2013 formulation of influenza vaccine
- Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone, Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
Show all 18Show fewer
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
- Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine
- Personal history of Guillain-Barré syndrome
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the subject
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Boca Raton, Florida, 33432
Study site
Council Bluffs, Iowa, 51503
Study site
Metairie, Louisiana, 70006
Study site
South Miami, Florida, 33143
About this study
Official title: Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).
Primary Objective:
Read more
- To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational Objectives:
- To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
- To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
- To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.
Read the detailed description
Participants 18 to < 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days.
- Conditions
- Influenza
- Being tested
- Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation, Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation, Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
- Keywords
- Influenza, Influenza virus vaccine, Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation, Fluzone® High-Dose (Influenza Virus Vaccine) 2012-2013 Formulation, Trivalent Inactivated Influenza Vaccine, Fluzone® Intradermal (Influenza Virus Vaccine) 2012-2013 Formulation
- 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: Fluzone® 2012-2013 FormulationBiological
Also called Fluzone® (2012-2013 Formulation)
0.5 mL, Intramuscular
Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 FormulationBiological
Also called Fluzone® Intradermal (2012-2013 Formulation)
0.1 mL, Intradermal
Influenza Virus Vaccine: Fluzone® 2012-2013 FormulationBiological
Also called Fluzone® (2012-2013 Formulation)
0.5 mL, Intramuscular
Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 FormulationBiological
Also called Fluzone® High-Dose (2012-2013 Formulation)
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Fluzone vaccine (Group 1) | Experimental | Adults 18 to < 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly Receives: Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation |
| Fluzone Intradermal vaccine (Group 2) | Experimental | Adults 18 to < 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally Receives: Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation |
| Fluzone vaccine (Group 3) | Experimental | Adults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly Receives: Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation |
| Fluzone High-Dose Vaccine (Group 4) | Active comparator | Adults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly Receives: Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
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 posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionFeb 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.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691339
- Sponsor's protocol ID
- GRC50
- Other IDs
- U 1111-1124-8310
- Status last verified
- Aug 2013
- First submitted
- 19 Sep 2012
- Last updated
- 4 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)
- ClinicalTrials.gov ID
- NCT01691339
- Acronym / sponsor ID
- GRC50
- Conditions
- Influenza
- Keywords
- Influenza, Influenza virus vaccine, Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation, Fluzone® High-Dose (Influenza Virus Vaccine) 2012-2013 Formulation, Trivalent Inactivated Influenza Vaccine, Fluzone® Intradermal (Influenza Virus Vaccine) 2012-2013 Formulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 4 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).
Primary Objective:
- To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
Observational Objectives:
- To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
- To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
- To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.
Detailed description
Participants 18 to < 65 years of age will be randomized to receive a dose of either Fluzone or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 21 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fluzone vaccine (Group 1) | Experimental | Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 FormulationAdults 18 to < 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly |
| Fluzone Intradermal vaccine (Group 2) | Experimental | Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 FormulationAdults 18 to < 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally |
| Fluzone vaccine (Group 3) | Experimental | Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 FormulationAdults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly |
| Fluzone High-Dose Vaccine (Group 4) | Active comparator | Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 FormulationAdults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years of age on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (18 listed)
- History of serious adverse reaction to any influenza vaccine
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
- Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
- Prior vaccination with any 2012 - 2013 formulation of influenza vaccine
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: Fluzone® 2012-2013 FormulationAlso: Fluzone® (2012-2013 Formulation)0.5 mL, Intramuscular | Biological | Fluzone vaccine (Group 1) |
| Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 FormulationAlso: Fluzone® Intradermal (2012-2013 Formulation)0.1 mL, Intradermal | Biological | Fluzone Intradermal vaccine (Group 2) |
| Influenza Virus Vaccine: Fluzone® 2012-2013 FormulationAlso: Fluzone® (2012-2013 Formulation)0.5 mL, Intramuscular | Biological | Fluzone vaccine (Group 3) |
| Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 FormulationAlso: Fluzone® High-Dose (2012-2013 Formulation)0.5 mL, Intramuscular | Biological | Fluzone High-Dose Vaccine (Group 4) |
Primary outcome
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
Time frame: Day 0 up to Day 7 post-vaccination
Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation, Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation and Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 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 3 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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 4 Nov 2013). 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?
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine (time frame: Day 0 up to Day 7 post-vaccination). 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 4 Nov 2013.