InfluenzaPhase 3NCT01218646

Study of Quadrivalent Influenza Vaccine Among Adults

A Phase 3 study testing Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative, Investigational Trivalent Inactivated Influenza Vaccine, No Preservative and Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 12 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 a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative, Investigational Trivalent Inactivated Influenza Vaccine, No Preservative and Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 739 participants
Where: 12 sitesUnited States
Study dates: Oct 2010to Apr 2011
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is 18 years of age or older 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.
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination.

Who cannot join

Known pregnancy, or a positive urine pregnancy test.
Currently breastfeeding a child.
History of serious adverse reaction to any influenza vaccine.
Receipt of any vaccine in the 4 weeks preceding the trial vaccination.
Planned receipt of any vaccine between Visit 1 and Visit 2.
Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study.

Show all 18Show fewer

Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent vaccine).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating intramuscular vaccination.
Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
Personal history of Guillain-Barré Syndrome (GBS).
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).
Any chronic illness that, in the opinion of the Investigator, is not well controlled or that may interfere with trial conduct or completion or with assessment of adverse events.
Known 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 or drug use that, in the opinion of the Investigator, 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

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Study site
Allentown, Pennsylvania, 18102
Study site
Bensalem, Pennsylvania, 19020
Study site
Cincinnati, Ohio, 45249
Study site
Hoover, Alabama, 35216
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37212
Study site
New York, New York, 10004
Study site
Rochester, New York, 14609
Study site
San Antonio, Texas, 78229
Study site
South Miami, Florida, 33143
Study site
Springfield, Missouri, 65802
Study site
Warwick, Rhode Island, 02866

Other trials in United States

About this study

Official title: Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine

Primary Objective:

To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older

Observational Objective:

To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Read the detailed description

All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)

Conditions: Influenza
Being tested: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative, Investigational Trivalent Inactivated Influenza Vaccine, No Preservative, Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
Keywords: Influenza, Quadrivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine, Influenza viruses
Medical subject headings: Influenza, Human

What participants receive

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

Investigational Quadrivalent Inactivated Influenza Vaccine, No PreservativeBiological
0.5 mL, Intramuscular
Investigational Trivalent Inactivated Influenza Vaccine, No PreservativeBiological
0.5 mL, Intramuscular
Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No PreservativeBiological
Also called Fluzone®
0.5 mL, Intramuscular
Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No PreservativeBiological
Also called Fluzone®
0.5 mL, Intramuscular

Study groups in NCT01218646
Study group	Role	What they receive
Group 1: Investigational Quadrivalent Influenza Vaccine	Experimental	Participants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine Receives: Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
Group 2: Investigational Trivalent Influenza Vaccine	Experimental	Participants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine Receives: Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative
Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine	Active comparator	Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine Receives: Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine	Active comparator	Participants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine Receives: Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative

What is being measured

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

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Measured: Day 21 post-vaccination
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Measured: Day 21 post-vaccination
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Measured: Day 0 and Day 21 post-vaccination

Timeline

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

Oct 2010Apr 2011

First posted11 Oct 2010 (estimated)
Study startOct 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 739 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01218646
Sponsor's protocol ID: QIV03
Other IDs: UTN: U1111-1113-3619
Status last verified: Sep 2013
First submitted: 8 Oct 2010
Last updated: 23 Oct 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 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine
ClinicalTrials.gov ID: NCT01218646
Acronym / sponsor ID: QIV03
Conditions: Influenza
Keywords: Influenza, Quadrivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine, Influenza viruses
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 739 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Mar 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 11 Oct 2010 (estimated)
Results: Posted 12 Sep 2013

Clinical summary

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

Primary Objective:

To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older

Observational Objective:

To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Detailed description

All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)

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
Group 1: Investigational Quadrivalent Influenza Vaccine	Experimental	Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No PreservativeParticipants will receive a dose of Investigational Quadrivalent Inactivated Influenza Vaccine
Group 2: Investigational Trivalent Influenza Vaccine	Experimental	Biological: Investigational Trivalent Inactivated Influenza Vaccine, No PreservativeParticipants will receive a dose of Investigational Trivalent Inactivated Influenza Vaccine
Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine	Active comparator	Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No PreservativeParticipants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine
Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine	Active comparator	Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No PreservativeParticipants will receive a dose of Licensed 2010-2011 Trivalent Inactivated Influenza Vaccine

Who may qualify

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

Key inclusion criteria (4 listed)

Subject is 18 years of age or older 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.
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination.

Key exclusion criteria (18 listed)

Known pregnancy, or a positive urine pregnancy test.
Currently breastfeeding a child.
History of serious adverse reaction to any influenza vaccine.
Receipt of any vaccine in the 4 weeks preceding the trial vaccination.
Planned receipt of any vaccine between Visit 1 and Visit 2.

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
Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative0.5 mL, Intramuscular	Biological	Group 1: Investigational Quadrivalent Influenza Vaccine
Investigational Trivalent Inactivated Influenza Vaccine, No Preservative0.5 mL, Intramuscular	Biological	Group 2: Investigational Trivalent Influenza Vaccine
Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No PreservativeAlso: Fluzone®0.5 mL, Intramuscular	Biological	Group 3: Licensed 2010-2011 Trivalent Influenza Vaccine
Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No PreservativeAlso: Fluzone®0.5 mL, Intramuscular	Biological	Group 4: Licensed 2010-2011 Trivalent Influenza Vaccine

Primary outcome

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.
Time frame: Day 21 post-vaccination
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
Time frame: Day 21 post-vaccination
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older
Time frame: Day 0 and Day 21 post-vaccination
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Results and safety

Results posted to the registry on 12 Sep 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
Group 1 (Investigational Quadrivalent Influenza Vaccine)	225	224
Group 2 (Investigational Trivalent Influenza Vaccine)	225	225
Group 3 (Licensed Trivalent Influenza Vaccine)	225	223
Group 4 (Licensed Trivalent Influenza Vaccine)	64	63

Primary outcome: Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.

Time frame: Day 21 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n = 220	Group 2 (Investigational Trivalent Influenza Vaccine) n = 221	Group 3 (Licensed Trivalent Influenza Vaccine) n = 219	Group 4 (Licensed Trivalent Influenza Vaccine) n = 0
B/Brisbane/60/2008 (220, 0, 219, 0)	73.8 (63.9 to 85.3)	NA (NA to NA)	57.9 (50.6 to 66.4)	–
B/Florida/04/2006 (220, 221, 0, 0)	61.1 (52.5 to 71.2)	54.8 (47.5 to 63.3)	NA (NA to NA)	–

Population analysed: Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (\<LLOQ or \>ULOQ).

Primary outcome: Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.

Time frame: Day 21 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n = 220	Group 2 (Investigational Trivalent Influenza Vaccine) n = 221	Group 3 (Licensed Trivalent Influenza Vaccine) n = 219	Group 4 (Licensed Trivalent Influenza Vaccine) n = 0
B/Brisbane/60/2008 (220, 221, 0, 0)	73.8 (63.9 to 85.3)	42.2 (36.5 to 48.7)	NA (NA to NA)	–
B/Florida/04/2006 (220, 0, 219, 0)	61.1 (52.5 to 71.2)	NA (NA to NA)	28.5 (24.6 to 33.0)	–

Population analysed: Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population

Primary outcome: Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older

Time frame: Day 0 and Day 21 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1 (Investigational Quadrivalent Influenza Vaccine) n = 220	Group 2 (Investigational Trivalent Influenza Vaccine) n = 221	Group 3 (Licensed Trivalent Influenza Vaccine) n = 219	Group 4 (Licensed Trivalent Influenza Vaccine) n = 59
A/H1N1, Pre-vaccination	21.7 (17.9 to 26.3)	21.1 (17.5 to 25.5)	24.8 (20.4 to 30.1)	26.7 (17.7 to 40.2)
A/H1N1, Post-vaccination	231 (188 to 283)	271 (221 to 331)	269 (221 to 328)	728 (515 to 1030)
A/H3N2, Pre-vaccination	52.3 (42.1 to 65.0)	42.3 (34.9 to 51.4)	48.3 (40.0 to 58.4)	33.0 (22.1 to 49.1)
A/H3N2, Post vaccination	501 (422 to 593)	360 (302 to 429)	291 (243 to 347)	503 (361 to 701)
B/Brisbane, Pre-vaccination	27.1 (23.3 to 31.5)	28.5 (24.2 to 33.6)	29.0 (25.0 to 33.7)	18.9 (14.0 to 25.4)
B/Brisbane, Post-vaccination	73.8 (63.9 to 85.3)	42.2 (36.5 to 48.7)	57.9 (50.6 to 66.4)	97.7 (75.0 to 127)
B/Florida, Pre-vaccination	20.2 (17.5 to 23.3)	19.7 (17.2 to 22.6)	18.7 (16.4 to 21.3)	19.5 (14.5 to 26.3)
B/Florida, Post-vaccination	61.1 (52.5 to 71.2)	54.8 (47.5 to 63.3)	28.5 (24.6 to 33.0)	48.6 (35.5 to 66.4)

Population analysed: Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population

Adverse events

Time frame: Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Investigational Quadrivalent Influenza Vaccine)	0 of 225 (0%)	73 of 225 (32.4%)	Not reported
Group 2 (Investigational Trivalent Influenza Vaccine)	1 of 225 (0.4%)	52 of 225 (23.1%)	Not reported
Group 3 (Licensed Trivalent Influenza Vaccine)	2 of 225 (0.9%)	64 of 225 (28.4%)	Not reported
Group 4 (Licensed Trivalent Influenza Vaccine)	0 of 64 (0%)	31 of 64 (48.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.

12 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 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 12 Sep 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?

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. (time frame: Day 21 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 NCT01218646.

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 23 Oct 2013.