Orthomyxoviridae InfectionPhase 3NCT00391053

Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

A Phase 3 study testing High-Dose Inactivated, Split-Virion Influenza Vaccine and Inactivated, Split-Virion Influenza Vaccine in people with Orthomyxoviridae Infection and Influenza, run by Sanofi Pasteur, a Sanofi Company at 28 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

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
What is being tested?: High-Dose Inactivated, Split-Virion Influenza Vaccine and Inactivated, Split-Virion Influenza Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,851 participants
Where: 28 sitesUnited States
Study dates: Oct 2006to Feb 2008
Phase: Phase 3
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

Aged ≥ 65 years on the day of vaccination.
Informed consent form signed.
Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination.)
Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing any of the same substances.
Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.
Systemic corticosteroid therapy, as follows:
Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination.
Sporadic use with a dosage equivalent to > 40 mg/day of oral prednisone for > 14 consecutive days in the 90 days preceding vaccination.
Note:Use of topical or inhalant corticosteroids is acceptable.

Show all 21Show fewer

Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease-free for ≥ 5 years).
Current alcohol abuse or drug addiction that in the opinion of the investigator may interfere with the subject's ability to comply with trial procedures.
Receipt of blood or blood-derived products in the past three months.
Participation in a trial of a high-dose influenza vaccine in the past 12 months.
Receipt of influenza vaccine in the past six months.
Receipt of any other vaccine in the past four weeks.
Planned receipt of any other vaccine in the four weeks following the trial vaccination.
Participation in another clinical trial in the past four weeks.
Planned participation in another clinical trial during the present trial period.
Note:Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
History of Guillain-Barré syndrome.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
An acute febrile illness (oral temperature ≥ 99.5ºF [≥ 37.5ºC]) within 24 hours prior to vaccination. If this contraindication exists, vaccination will be deferred until the participant has been afebrile for at least 24 hours.
Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Study site
Cary, North Carolina
Study site
Clearwater, Florida
Study site
Coral Gables, Florida
Study site
Dallas, Texas
Study site
Downington, Pennsylvania
Study site
Endwell, New York
Study site
Erie, Pennsylvania
Study site
Kansas City, Missouri
Study site
Marshfield, Wisconsin
Study site
Mesa, Arizona
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Pembroke Pines, Florida
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Rockville, Maryland
Study site
San Diego, California
Study site
St Louis, Missouri
Study site
Stratford, Connecticut
Study site
Tempe, Arizona
Study site
Tucson, Arizona
Study site
Warwick, Rhode Island
Study site
West Jordan, Utah
Study site
Wichita, Kansas

Other trials in United States

About this study

Official title: Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.

Primary Objectives:

Immunogenicity:

To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots.
To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine.

Secondary Objectives:

Immunogenicity:

To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine.

Safety:

To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination.
To describe clinical information on some additional defined criteria during the six months following vaccination.

Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Being tested: High-Dose Inactivated, Split-Virion Influenza Vaccine, Inactivated, Split-Virion Influenza Vaccine
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Adults
Medical subject headings: Orthomyxoviridae Infections, Influenza, Human

What participants receive

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

High-Dose Inactivated, Split-Virion Influenza VaccineBiological
Also called Fluzone® High-Dose
0.5 mL, IM
High-Dose Inactivated, Split-Virion Influenza VaccineBiological
Also called Fluzone® High-Dose
0.5 mL, IM
High-Dose Inactivated, Split-Virion Influenza VaccineBiological
Also called Fluzone® High-Dose
0.5 mL, IM
Inactivated, Split-Virion Influenza VaccineBiological
Also called Fluzone® 2006-2007 formulation
0.5 mL, IM

Study groups in NCT00391053
Study group	Role	What they receive
Study Group 1	Experimental	Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 Receives: Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
Study Group 2	Experimental	Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 Receives: Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
Study Group 3	Experimental	Participants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 Receives: Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
Group 4	Active comparator	Participants will receive the Standard Fluzone® vaccine Receives: Biological: Inactivated, Split-Virion Influenza Vaccine

What is being measured

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

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
Measured: Day 0 and Day 28 Post-vaccination
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).
Measured: Day 28 Post-vaccination

Secondary outcomes (2)

Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.
Measured: Day 0 and Day 28 Post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.
Measured: Day 0 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.

Oct 2006Feb 2008

First posted23 Oct 2006 (estimated)
Study startOct 2006
Primary completionJul 2007
Study completionFeb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Orthomyxoviridae InfectionStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,851 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00391053
Sponsor's protocol ID: FIM05
Status last verified: Apr 2016
First submitted: 20 Oct 2006
Last updated: 14 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009 Jul 15;200(2):172-80. doi: 10.1086/599790.
PubMed 19508159

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 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.
ClinicalTrials.gov ID: NCT00391053
Acronym / sponsor ID: FIM05
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,851 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Jul 2007 (actual)
Study completion: Feb 2008 (actual)
First posted: 23 Oct 2006 (estimated)
Results: Posted 30 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objectives:

Immunogenicity:

To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots.
To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine.

Secondary Objectives:

Immunogenicity:

To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine.

Safety:

To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination.
To describe clinical information on some additional defined criteria during the six months following vaccination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Study Group 1	Experimental	Biological: High-Dose Inactivated, Split-Virion Influenza VaccineParticipants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1
Study Group 2	Experimental	Biological: High-Dose Inactivated, Split-Virion Influenza VaccineParticipants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2
Study Group 3	Experimental	Biological: High-Dose Inactivated, Split-Virion Influenza VaccineParticipants will receive the High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3
Group 4	Active comparator	Biological: Inactivated, Split-Virion Influenza VaccineParticipants will receive the Standard Fluzone® vaccine

Who may qualify

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

Key inclusion criteria (4 listed)

Aged ≥ 65 years on the day of vaccination.
Informed consent form signed.
Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 weeks preceding vaccination.)
Able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (21 listed)

Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing any of the same substances.
Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.
Systemic corticosteroid therapy, as follows:
Continuous use with a dosage equivalent to > 15 mg/day of oral prednisone for 90 days preceding vaccination.
Sporadic use with a dosage equivalent to > 40 mg/day of oral prednisone for > 14 consecutive days in the 90 days preceding vaccination.

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 Inactivated, Split-Virion Influenza VaccineAlso: Fluzone® High-Dose0.5 mL, IM	Biological	Study Group 1
High-Dose Inactivated, Split-Virion Influenza VaccineAlso: Fluzone® High-Dose0.5 mL, IM	Biological	Study Group 2
High-Dose Inactivated, Split-Virion Influenza VaccineAlso: Fluzone® High-Dose0.5 mL, IM	Biological	Study Group 3
Inactivated, Split-Virion Influenza VaccineAlso: Fluzone® 2006-2007 formulation0.5 mL, IM	Biological	Group 4

Primary outcome

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
Time frame: Day 0 and Day 28 Post-vaccination
Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.
Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Time frame: Day 28 Post-vaccination
Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).

2 secondary outcomes

Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
Time frame: Day 0 and Day 28 Post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
Time frame: Day 0 to Day 7 Post-vaccination

Results and safety

Results posted to the registry on 30 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1	857	848
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2	848	847
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3	870	868
Active Comparator (Standard Fluzone®)	1,262	1,252

Primary outcome: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.

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

Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n = 854	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n = 861	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n = 861	Active Comparator (Standard Fluzone®) n = 1275
A/H1N1 New Caledonia Pre-Dose	28.25 (26.37 to 30.26)	29.41 (27.39 to 31.57)	27.86 (25.94 to 29.93)	29.36 (27.72 to 31.11)
A/H1N1 New Caledonia Post-Dose	112.77 (105.64 to 120.37)	114.63 (107.18 to 122.61)	120.02 (112.12 to 128.48)	67.29 (63.65 to 71.13)
A/H3N2 Wisconsin Pre-Dose	74.53 (67.29 to 82.55)	77.3 (69.5 to 85.97)	72.07 (65.12 to 79.77)	74.74 (68.64 to 81.37)
A/H3N2 Wisconsin Post-Dose	595.03 (552.8 to 640.49)	628.54 (583.21 to 677.4)	603.59 (561.33 to 649.03)	332.46 (310.44 to 356.05)
B/Malaysia Pre-Dose	19.24 (17.98 to 20.58)	18.96 (17.71 to 20.29)	19.78 (18.49 to 21.16)	18.96 (17.93 to 20.04)
B/Malaysia Post-Dose	68.98 (64.77 to 73.47)	69.26 (64.99 to 73.81)	68.93 (64.81 to 73.3)	52.34 (49.48 to 55.35)

Population analysed: The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.

Primary outcome: Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.

Time frame: Day 28 Post-vaccination. Number. Unit: Percentage of Participants

Measure	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1 n = 854	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2 n = 861	High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3 n = 861	Active Comparator (Standard Fluzone®) n = 1275
A/H1N1 New Caledonia	47	47	52	23
A/H3N2 Wisconsin	70	68	70	51
B/Malaysia	43	41	42	30

Population analysed: The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from day of vaccination (Day 0) for 6 months post-vaccination. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1	56 of 855 (6.5%)	455 of 855 (53.2%)	Not reported
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2	56 of 848 (6.6%)	454 of 848 (53.5%)	Not reported
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3	44 of 870 (5.1%)	449 of 870 (51.6%)	Not reported
Standad Dose Inactivated, Split-Virion Influenza Vaccine	93 of 1,260 (7.4%)	544 of 1,260 (43.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19508159Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009 Jul 15;200(2):172-80. doi: 10.1086/599790.
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.

28 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 4 inclusion and 21 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Apr 2010). 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 Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines. (time frame: Day 0 and Day 28 Post-vaccination). The study lists 2 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 NCT00391053, which also lists 1 linked publication.

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 14 Apr 2016.