InfluenzaPhase 4NCT01430819

Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

A Phase 4 study testing Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation and Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 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 aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation and Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 6 sitesUnited States
Study dates: Sep 2011to Feb 2012
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Subject is ≥ 65 years of age on the day of inclusion.
Informed consent form (ICF) 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 the 2nd visit.
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.
Influenza vaccination in the 6 months preceding enrollment in the study.
Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone 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 Investigator's Brochure and/or the package insert) .
Receipt of immune globulins, blood, or blood-derived products in the past 3 months.

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Thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for IM vaccination, at the discretion of the Investigator.
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 ≥ 38.0°C [≥ 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

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Austin, Texas, 78705
Study site
Bensalem, Pennsylvania, 19020
Study site
Colorado Springs, Colorado, 80920
Study site
Council Buffs, Iowa, 51503
Study site
Metairie, Louisiana, 70006
Study site
Springfield, Missouri, 65804

Other trials in United States

About this study

Official title: Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)

The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older.

Objectives:

To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.

Read the detailed description

Historically, the annual safety and immunogenicity study of Fluzone vaccine has been conducted in the US in support of licenses held by sanofi pasteur in various countries.

Participants will be randomized to receive a dose of either Fluzone® or Fluzone® High-Dose vaccine and will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 1 month.

Conditions: Influenza
Being tested: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation, Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
Keywords: Influenza, Influenza Virus Vaccine, Fluzone® 2011-2012 Formulation, Fluzone® High-Dose 2011-2012 Formulation, Trivalent Inactivated Influenza Vaccine
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® 2011-2012 FormulationBiological
Also called Fluzone® 2011-2012 Formulation
0.5 mL, Intramuscular
Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 FormulationBiological
Also called Fluzone® High-Dose 2011-2012 Formulation
0.5 mL, Intramuscular

Study groups in NCT01430819
Study group	Role	What they receive
Fluzone® Vaccine Group	Experimental	Participants will receive the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation Receives: Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Fluzone® High-Dose Vaccine Group	Active comparator	Participants will receive the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation. Receives: Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation

What is being measured

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

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm.
Measured: Day 0 to up to Day 28 post-vaccination

Timeline

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

Sep 2011Feb 2012

First posted8 Sep 2011 (estimated)
Study startSep 2011
Primary completionFeb 2012
Study completionFeb 2012

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430819
Sponsor's protocol ID: GRC48
Other IDs: U 1111-1120-1287
Status last verified: May 2013
First submitted: 7 Sep 2011
Last updated: 27 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 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 Vaccine 2011-2012 Formulation (Intramuscular Route)
ClinicalTrials.gov ID: NCT01430819
Acronym / sponsor ID: GRC48
Conditions: Influenza
Keywords: Influenza, Influenza Virus Vaccine, Fluzone® 2011-2012 Formulation, Fluzone® High-Dose 2011-2012 Formulation, Trivalent Inactivated Influenza Vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 8 Sep 2011 (estimated)
Results: Posted 16 May 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 the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older.

Objectives:

To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.

Detailed description

Historically, the annual safety and immunogenicity study of Fluzone vaccine has been conducted in the US in support of licenses held by sanofi pasteur in various countries.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fluzone® Vaccine Group	Experimental	Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 FormulationParticipants will receive the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Fluzone® High-Dose Vaccine Group	Active comparator	Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 FormulationParticipants will receive the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Subject is ≥ 65 years of age on the day of inclusion.
Informed consent form (ICF) has been signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (17 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 the 2nd visit.
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.
Influenza vaccination in the 6 months preceding enrollment in the study.
Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone 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 Investigator's Brochure and/or the package insert) .

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® 2011-2012 FormulationAlso: Fluzone® 2011-2012 Formulation0.5 mL, Intramuscular	Biological	Fluzone® Vaccine Group
Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 FormulationAlso: Fluzone® High-Dose 2011-2012 Formulation0.5 mL, Intramuscular	Biological	Fluzone® High-Dose Vaccine Group

Primary outcome

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
Time frame: Day 0 to up to Day 28 post-vaccination
Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm.

Results and safety

Results posted to the registry on 16 May 2013, 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® Vaccine Group	150	150
Fluzone® High-Dose Vaccine Group	150	150

Primary outcome: Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine

Time frame: Day 0 to up to Day 28 post-vaccination. Number. Unit: Participants

Measure	Fluzone® Vaccine Group n = 150	Fluzone® High-Dose Vaccine Group n = 150
Any injection site Pain	36	79 (0 to 0)
Grade 3 injection site Pain	1	0 (0 to 0)
Any injection site Erythema	7	13 (0 to 0)
Grade 3 injection site Erythema	0	2 (0 to 0)
Any injection site Swelling	4	10 (0 to 0)
Grade 3 injection site Swelling	0	0 (0 to 0)
Any Fever	2	1 (0 to 0)
Grade 3 Fever	0	0 (0 to 0)

Population analysed: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).

Adverse events

Time frame: Adverse events were recorded following vaccination (Day 0) for up to 28 days post-vaccination. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluzone® Vaccine Group	1 of 150 (0.7%)	36 of 150 (24%)	Not reported
Fluzone® High-Dose Vaccine Group	0 of 150 (0%)	79 of 150 (52.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.

6 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 3 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 16 May 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 at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine (time frame: Day 0 to up to Day 28 post-vaccination). 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 NCT01430819.

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 27 May 2013.