InfluenzaPhase 2NCT00551031

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

A Phase 2 study testing Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1), Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2) and Split, Inactivated, Trivalent Influenza Vaccine (Standard dose) in people with Influenza and Myxovirus Infection, run by Sanofi at 29 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 present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza, Myxovirus Infection
What is being tested?: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1), Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2) and Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,098 participants
Where: 29 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination.
Informed consent form signed.
Medically stable (Subjects may have underlying illnesses 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.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

Who cannot join

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances.
Known or suspected congenital or acquired immunodeficiency, hepatitis B (HBsAg) or hepatitis C infection or seropositivity immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.
Breast feeding woman.
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 use of alcohol or recreational drugs that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures.

Show all 22Show fewer

Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
Vaccination against influenza in the past 6 months.
Any vaccination in the 4 weeks preceding the trial vaccination.
Planned receipt of any other vaccine in the four weeks following the trial vaccination.
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination.
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.
Known thrombocytopenia or bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
Personal or family history of Guillain-Barré Syndrome.
Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
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 ≥ 99.5°F (≥ 37.5°C)] within 24 hours prior to vaccination. If this exists, vaccination will be deferred until the participant becomes afebrile.
Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
The use of an antibiotics therapy within 72 hours preceding the trial vaccination. If this exists, vaccination will be deferred until at least 72 hours after the last antibiotics therapy.
Receipt of any allergy shots in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots in the 7-day period after enrollment (vaccination). Subjects should be enrolled in the trial only if their allergy shots are given on a stable schedule outside the 7-day periods pre- and post-vaccination.

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

Study site
Alabaster, Alabama
Study site
Allentown, Pennsylvania
Study site
Bensalem, Pennsylvania
Study site
Boise, Idaho
Study site
Cary, North Carolina
Study site
Chandler, Arizona
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Galveston, Texas
Study site
Goose Creek, South Carolina
Study site
Kansas City, Missouri
Study site
Marshfield, Wisconsin
Study site
Mesa, Arizona
Study site
Mobile, Alabama
Study site
Pembroke Pines, Florida
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
Raleigh, North Carolina
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Springfield, Missouri
Study site
St Louis, Missouri
Study site
Stanford, Connecticut
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: Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data.

Primary Objective:

To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects.

Secondary Objectives:

Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.

Safety:

To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Conditions: Influenza, Myxovirus Infection
Being tested: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1), Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2), Split, Inactivated, Trivalent Influenza Vaccine (Standard dose), Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
Keywords: Influenza, Orthomyxoviruses, Myxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly
Medical subject headings: Influenza, Human

What participants receive

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

Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)Biological
0.1 mL, Intradermal (ID)
Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)Biological
0.1 mL, Intradermal (ID)
Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)Biological
Also called Fluzone®
0.5 mL, Intramuscular (IM)
Split, Inactivated, Trivalent Influenza Vaccine (High-dose)Biological
Also called Fluzone® High-dose
0.5 mL, Intramuscular (IM)
Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)Biological
Also called Fluzone®
0.5 mL, Intramuscular (IM)

Study groups in NCT00551031
Study group	Role	What they receive
Influenza Virus Vaccine Formulation 1	Experimental	Influenza Virus Vaccine Formulation 1 Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
Influenza Virus Vaccine Formulation 2	Experimental	Influenza Virus Vaccine Formulation 2 Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
Fluzone® Elderly Group	Active comparator	Not described Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
Fluzone® High-dose Group	Active comparator	Participants enrolled at age ≥ 65 years Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
Fluzone® Adults Group	Active comparator	Participants enrolled at age 18-49 years. Receives: Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)

What is being measured

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

Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Measured: Day 0 and Day 28 post vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Measured: Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Measured: Day 0 and Day 28 post-vaccination

Secondary outcomes (1)

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.
Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills
Measured: Days 0 through 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 2007Nov 2008

First posted30 Oct 2007 (estimated)
Study startOct 2007
Primary completionJun 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.
Publications (1)Papers the sponsor has linked to this study.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,098 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00551031
Sponsor's protocol ID: FID29
Status last verified: Apr 2016
First submitted: 29 Oct 2007
Last updated: 16 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tsang P, Gorse GJ, Strout CB, Sperling M, Greenberg DP, Ozol-Godfrey A, DiazGranados C, Landolfi V. Immunogenicity and safety of Fluzone((R)) intradermal and high-dose influenza vaccines in older adults >/=65 years of age: a randomized, controlled, phase II trial. Vaccine. 2014 May 1;32(21):2507-17. doi: 10.1016/j.vaccine.2013.09.074. Epub 2013 Oct 11.
PubMed 24120672

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: Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
ClinicalTrials.gov ID: NCT00551031
Acronym / sponsor ID: FID29
Conditions: Influenza, Myxovirus Infection
Keywords: Influenza, Orthomyxoviruses, Myxovirus Infection, Inactivated Split-virion influenza vaccine, Elderly
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,098 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jun 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 30 Oct 2007 (estimated)
Results: Posted 24 Nov 2011

Clinical summary

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

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data.

Primary Objective:

Secondary Objectives:

Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.

Safety:

To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Influenza Virus Vaccine Formulation 1	Experimental	Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)Influenza Virus Vaccine Formulation 1
Influenza Virus Vaccine Formulation 2	Experimental	Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)Influenza Virus Vaccine Formulation 2
Fluzone® Elderly Group	Active comparator	Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
Fluzone® High-dose Group	Active comparator	Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)Participants enrolled at age ≥ 65 years
Fluzone® Adults Group	Active comparator	Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)Participants enrolled at age 18-49 years.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged ≥ 65 years or aged 18 to 49 years on the day of vaccination.
Informed consent form signed.
Medically stable (Subjects may have underlying illnesses 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.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

Key exclusion criteria (22 listed)

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances.
Known or suspected congenital or acquired immunodeficiency, hepatitis B (HBsAg) or hepatitis C infection or seropositivity immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.
Breast feeding woman.
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).

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
Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)0.1 mL, Intradermal (ID)	Biological	Influenza Virus Vaccine Formulation 1
Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)0.1 mL, Intradermal (ID)	Biological	Influenza Virus Vaccine Formulation 2
Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)Also: Fluzone®0.5 mL, Intramuscular (IM)	Biological	Fluzone® Elderly Group
Split, Inactivated, Trivalent Influenza Vaccine (High-dose)Also: Fluzone® High-dose0.5 mL, Intramuscular (IM)	Biological	Fluzone® High-dose Group
Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)Also: Fluzone®0.5 mL, Intramuscular (IM)	Biological	Fluzone® Adults Group

Primary outcome

Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Time frame: Day 0 and Day 28 post vaccination
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
Time frame: Day 28 post-vaccination
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.
Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Time frame: Day 0 and Day 28 post-vaccination
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40

1 secondary outcome

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
Time frame: Days 0 through 7 post-vaccination

Results and safety

Results posted to the registry on 24 Nov 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
Influenza Virus Vaccine Formulation 1	637	635
Influenza Virus Vaccine Formulation 2	636	625
Fluzone® Elderly Group	319	317
Fluzone® High Dose Group	320	317
Fluzone® Adults Group	186	185

Primary outcome: Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.

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

Measure	Influenza Virus Vaccine Formulation 1 n = 607	Influenza Virus Vaccine Formulation 2 n = 608	Fluzone® Elderly Group n = 304	Fluzone® High Dose Group n = 309	Fluzone® Adults Group n = 179
A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)	18.3 (16.9 to 19.8)	18.6 (17.1 to 20.2)	17.8 (15.7 to 20.0)	17.3 (15.3 to 19.5)	41.4 (32.6 to 52.7)
A/H1N1 Post Dose (N=605, 607, 304, 309, 179)	165.4 (149.2 to 183.4)	174.1 (157.5 to 192.4)	107.6 (93.2 to 124.3)	236.1 (207.3 to 268.9)	345.8 (294.1 to 406.6)
A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)	103.8 (93.1 to 115.9)	104.7 (93.9 to 116.7)	95.1 (82.1 to 110.3)	99.3 (84.6 to 116.7)	73.0 (58.7 to 90.8)
A/H3N2 Post Dose (N=605, 608, 304, 309, 179)	348.3 (320.2 to 378.9)	378.4 (346.9 to 412.7)	276.9 (245.8 to 311.8)	508.0 (452.6 to 570.1)	398.3 (343.4 to 461.9)
B Pre Dose (N=607, 608, 304, 309, 179)	24.7 (22.9 to 26.6)	25.1 (23.3 to 27.1)	24.7 (22.2 to 27.4)	24.1 (21.7 to 26.8)	15.5 (13.4 to 17.9)
B Post Dose (N=607, 608, 304, 309, 179)	45.3 (42.3 to 48.4)	47.5 (44.3 to 50.9)	43.4 (39.2 to 48.0)	59.9 (54.5 to 65.9)	71.2 (61.7 to 82.3)

Population analysed: Serum antibody titers GMTs were assessed in the per-protocol population.

Primary outcome: Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine

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

Measure	Influenza Virus Vaccine Formulation 1 n = 607	Influenza Virus Vaccine Formulation 2 n = 608	Fluzone® Elderly Group n = 304	Fluzone® High Dose Group n = 309	Fluzone® Adults Group n = 179
A/H1N1 (N=604, 607, 304, 309, 179)	73	74	61 (0 to 0)	82	62
A/H3N2 (N=605, 608, 304, 309, 179)	42	42	37 (0 to 0)	56	52
B (N=607, 608, 304, 309, 179)	15	15	9 (0 to 0)	26	44

Population analysed: Serum antibody titers were assessed in the per protocol population.

Primary outcome: Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.

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

Measure	Influenza Virus Vaccine Formulation 1 n = 607	Influenza Virus Vaccine Formulation 2 n = 608	Fluzone® Elderly Group n = 304	Fluzone® High Dose Group n = 309	Fluzone® Adults Group n = 179
A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)	27	25	25	23	49
A/H1N1 Post Dose (N=605, 607, 304, 309, 179)	88	90	79	94	97
A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)	78	79	80	78	72
A/H3N2 Post Dose (N=605, 608, 304, 309, 179)	98	98	97	99	99
B Pre Dose (N=607, 608, 304, 309, 179)	38	37	39	37	25
B Post Dose (N=607, 608, 304, 309, 179)	65	67	62	77	79

Population analysed: Serum antibody titers were assessed in the per protocol population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination up to 6 months post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza Virus Vaccine Formulation 1	34 of 635 (5.4%)	426 of 635 (67.1%)	Not reported
Influenza Virus Vaccine Formulation 2	38 of 635 (6%)	434 of 635 (68.3%)	Not reported
Fluzone® Elderly Group	21 of 319 (6.6%)	57 of 319 (17.9%)	Not reported
Fluzone® High Dose Group	16 of 320 (5%)	117 of 320 (36.6%)	Not reported
Fluzone® Adults Group	7 of 186 (3.8%)	106 of 186 (57%)	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.
Derived from this study: PubMed 24120672Tsang P, Gorse GJ, Strout CB, Sperling M, Greenberg DP, Ozol-Godfrey A, DiazGranados C, Landolfi V. Immunogenicity and safety of Fluzone((R)) intradermal and high-dose influenza vaccines in older adults >/=65 years of age: a randomized, controlled, phase II trial. Vaccine. 2014 May 1;32(21):2507-17. doi: 10.1016/j.vaccine.2013.09.074. Epub 2013 Oct 11.
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.

29 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 22 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 29 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 24 Nov 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) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. (time frame: Day 0 and Day 28 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?

On the ClinicalTrials.gov record for NCT00551031, 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 16 May 2016.