InfluenzaPhase 2NCT01258595

A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

A Phase 2 study testing High-Dose Trivalent Inactivated Influenza Vaccine and Trivalent Inactivated Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 5 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 generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. Read more about this study

Who is it for?: Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: High-Dose Trivalent Inactivated Influenza Vaccine and Trivalent Inactivated Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 5 sitesUnited States
Study dates: Nov 2010to Apr 2011
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 50 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 50 to 64 years (inclusive) on the day of vaccination
Informed consent form has been signed and dated
Medically stable
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination

Who cannot join

Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
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
Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)
Receipt of seasonal or pandemic influenza vaccine in the past 6 months

Show all 16Show fewer

Receipt of blood or blood-derived products in the past 3 months
Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances
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
Neoplastic disease or any hematologic malignancy
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
Personal history of Guillain-Barré Syndrome
Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Cleveland, Ohio, 44122
Study site
Columbia, Maryland, 21045
Study site
Ellicott City, Maryland, 21042
Study site
Idaho Falls, Idaho, 83404
Study site
Missoula, Montana, 59802

Other trials in United States

About this study

Official title: Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age

Primary Objective:

To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Read the detailed description

Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.

Conditions: Influenza
Being tested: High-Dose Trivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine
Keywords: Influenza, Trivalent Inactivated Influenza Vaccine, High-Dose Trivalent Inactivated Influenza Vaccine, Influenza vaccines
Medical subject headings: Influenza, Human

What participants receive

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

High-Dose Trivalent Inactivated Influenza VaccineBiological
Also called Fluzone® High-Dose
0.5 mL Intramuscular
Trivalent Inactivated Influenza VaccineBiological
Also called Fluzone®
0.5 mL, Intramuscular

Study groups in NCT01258595
Study group	Role	What they receive
High-Dose Trivalent Inactivated Influenza Vaccine	Experimental	Not described Receives: Biological: High-Dose Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine	Active comparator	Not described Receives: Biological: Trivalent Inactivated Influenza Vaccine

What is being measured

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

Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Measured: Day 0 and Day 28 post-vaccination
Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Measured: Day 0 and Day 28 Post-vaccination
Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.
Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Measured: Day 0 and Day 28 post-vaccination
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Measured: Day 0 and Day 28 post vaccination

Secondary outcomes (1)

Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Measured: Day 0 through 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.

Nov 2010Apr 2011

First posted13 Dec 2010 (estimated)
Study startNov 2010
Primary completionMar 2011
Study completionApr 2011

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01258595
Sponsor's protocol ID: FIM09
Other IDs: UTN: U1111-1113-3648
Status last verified: Apr 2016
First submitted: 10 Dec 2010
Last updated: 16 May 2016
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 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
ClinicalTrials.gov ID: NCT01258595
Acronym / sponsor ID: FIM09
Conditions: Influenza
Keywords: Influenza, Trivalent Inactivated Influenza Vaccine, High-Dose Trivalent Inactivated Influenza Vaccine, Influenza vaccines
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Mar 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 13 Dec 2010 (estimated)
Results: Posted 27 Oct 2011

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 generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age

Primary Objective:

To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Detailed description

Study design

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

Arm	Type	Receives
High-Dose Trivalent Inactivated Influenza Vaccine	Experimental	Biological: High-Dose Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine	Active comparator	Biological: Trivalent Inactivated Influenza Vaccine

Who may qualify

Ages: 50 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Aged 50 to 64 years (inclusive) on the day of vaccination
Informed consent form has been signed and dated
Medically stable
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination

Key exclusion criteria (16 listed)

Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
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
Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)

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
High-Dose Trivalent Inactivated Influenza VaccineAlso: Fluzone® High-Dose0.5 mL Intramuscular	Biological	High-Dose Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza VaccineAlso: Fluzone®0.5 mL, Intramuscular	Biological	Trivalent Inactivated Influenza Vaccine

Primary outcome

Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
Time frame: Day 0 and Day 28 post-vaccination
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Time frame: Day 0 and Day 28 Post-vaccination
Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.
Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Time frame: Day 0 and Day 28 post-vaccination
Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.
Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Time frame: Day 0 and Day 28 post vaccination
Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.

1 secondary outcome

Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Time frame: Day 0 through Day 7 post-vaccination

Results and safety

Results posted to the registry on 27 Oct 2011, 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® High-Dose Vaccine Group	148	147
Fluzone® Vaccine Group	152	151

Primary outcome: Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.

Time frame: Day 0 and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: 1/dilution (1/dil)

Measure	Fluzone® High-Dose Vaccine Group n = 147	Fluzone® Vaccine Group n = 152
A/H1N1: California - Pre-vaccination (N=147, 152)	40.5 (30.0 to 54.5)	28.8 (21.8 to 38.1)
A/H3N2: Victoria - Pre-vaccination (N=147, 152)	36.4 (28.0 to 47.4)	41.4 (31.4 to 54.6)
B: Brisbane - Pre-vaccination (N=147, 152)	27.4 (22.4 to 33.6)	28.9 (23.5 to 35.5)
A/H1N1: California - Post-vaccination (N=145, 151)	1067 (868 to 1312)	745 (585 to 948)
A/H3N2: Victoria - Post-vaccination (N = 145, 151)	936 (745 to 1176)	567 (459 to 699)
B: Brisbane - Post-vaccination (N=145, 151)	203 (171 to 241)	127 (104 to 154)

Population analysed: Serum antibody titers to vaccine antigens were assessed in the full analysis set population.

Primary outcome: Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

Time frame: Day 0 and Day 28 Post-vaccination. Geometric mean (95% Confidence Interval). Unit: 1/dilution (1/dil)

Measure	Fluzone® High-Dose Vaccine Group n = 145	Fluzone® Vaccine Group n = 151
A/H1N1: California	21.8 (16.1 to 29.6)	21.2 (15.8 to 28.4)
A/H3N2: Victoria	22.0 (17.2 to 28.1)	12.0 (9.21 to 15.5)
B: Brisbane	6.27 (5.16 to 7.62)	3.91 (3.17 to 4.83)

Population analysed: Serum antibody titers to vaccine antigens were assessed in the full analysis set population.

Primary outcome: Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

Time frame: Day 0 and Day 28 post-vaccination. Number. Unit: Percentage of Participants

Measure	Fluzone® High-Dose Vaccine Group n = 145	Fluzone® Vaccine Group n = 151
A/H1N1: California	78	78
A/H3N2: Victoria	89	76
B: Brisbane	64	41

Population analysed: Seroconversion to the vaccine antigens was assessed in the full analysis set population.

Primary outcome: Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

Time frame: Day 0 and Day 28 post vaccination. Number. Unit: Percentage of Participants

Measure	Fluzone® High-Dose Vaccine Group n = 147	Fluzone® Vaccine Group n = 152
A/H1N1: California - Pre-vaccination (N=147, 152)	50	41
A/H3N2: Victoria - Pre-vaccination (N=147, 152)	50	51
B: Brisbane - Pre-vaccination (N=147, 152)	46	47
A/H1N1: California - Post-vaccination (N=145, 151)	100	98
A/H3N2: Victoria - Post-vaccination (N=145, 151)	99	98
B: Brisbane - Post-vaccination (N=145, 151)	97	87

Population analysed: Seroprotection was assessed in the full analysis set population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination through 28 days post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluzone® High-Dose Vaccine Group	0 of 148 (0%)	130 of 148 (87.8%)	Not reported
Fluzone® Vaccine Group	0 of 152 (0%)	110 of 152 (72.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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.

5 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 5 inclusion and 16 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 27 Oct 2011). 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?

Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine. (time frame: Day 0 and Day 28 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 NCT01258595.

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 16 May 2016.