InfluenzaPhase 3NCT00764790

Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

A Phase 3 study testing Fluarix and Fluzone in people with Influenza, run by GlaxoSmithKline at 69 sites in 5 countries.

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 purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age. Read more about this study

Who is it for?: Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluarix and Fluzone
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,317 participants
Where: 69 sitesin 5 countries
Study dates: 1 Oct 2008to 1 Jun 2009
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 6 to 35 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject's parent/guardian.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Trial locations and contacts

69 sites in 5 countries.

Country

City, postcode or hospital

69 sites in 5 countries

United States62 sites

GSK Investigational Site
Arkansas City, Kansas, 67005
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Austintown, Ohio, 44515
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Benton, Arkansas, 72019
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Birmingham, Alabama, 35244
GSK Investigational Site
Boone, North Carolina, 28607
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Bountiful, Utah, 84010
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Clarksville, Tennessee, 37043
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Conway, Arkansas, 72034
GSK Investigational Site
Cortland, New York, 13045
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
DeKalb, Illinois, 60115
GSK Investigational Site
Dothan, Alabama, 36305
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fargo, North Dakota, 58103
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Henderson, Nevada, 89015
GSK Investigational Site
Houston, Texas, 77055
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jackson, Tennessee, 38305
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Latrobe, Pennsylvania, 15650
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Longmont, Colorado, 80501
GSK Investigational Site
Louisville, Kentucky, 40207
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
New Albany, Indiana, 47150
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Roy, Utah, 84067
GSK Investigational Site
Sacramento, California, 95816
GSK Investigational Site
Saint Paul, Minnesota, 55108
GSK Investigational Site
San Angelo, Texas, 76904
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
Wexford, Pennsylvania, 15090
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Hong Kong2 sites

GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin

Other trials in Hong Kong

Mexico2 sites

GSK Investigational Site
México, 6720
GSK Investigational Site
Mexico City, 04530

Other trials in Mexico

Taiwan2 sites

GSK Investigational Site
Taipei, 104
GSK Investigational Site
Taipei

Other trials in Taiwan

Thailand1 site

GSK Investigational Site
Bangkok, 10400

Other trials in Thailand

About this study

Official title: Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

Conditions: Influenza
Being tested: Fluarix, Fluzone
Medical subject headings: Influenza, Human

What participants receive

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

FluarixBiological
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
FluzoneBiological
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

Study groups in NCT00764790
Study group	Role	What they receive
Fluarix Dose A Group	Experimental	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. Receives: Biological: Fluarix
Fluarix Dose B Group	Experimental	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. Receives: Biological: Fluarix
Fluzone Group	Active comparator	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. Receives: Biological: Fluzone

What is being measured

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

Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Measured: Day 0 (PRE), Day 28 or Day 56 (POST)
Number of Subjects Who Seroconverted
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Measured: Day 28 or Day 56

Secondary outcomes (7)

Number of Seroprotected Subjects
A seroprotected subject is a subject with a serum anti-HA titer
≥ 1:40
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Measured: Day 0 (PRE), Day 28 or Day 56 (POST)
Seroconversion Factor
Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Measured: Day 28 or Day 56
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Measured: During a 4-day follow-up period after vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.
Measured: During a 4-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: During a 28-day follow-up period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders
Measured: During the entire study (Day 0 until Month 6)
Number of Subjects Reporting Rare Serious Events
Rare serious events have an occurrence rate of 1/300 (0.3%).
Measured: During the entire study (Day 0 until Month 6)

Timeline

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

1 Oct 20081 Jun 2009

First posted2 Oct 2008 (estimated)
Study start1 Oct 2008
Primary completion5 Mar 2009
Study completion1 Jun 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 3,317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00764790
Sponsor's protocol ID: 111751
Status last verified: Oct 2016
First submitted: 1 Oct 2008
Last updated: 31 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
PubMed 29465480
Pavia-Ruz N, Angel Rodriguez Weber M, Lau YL, Nelson EA, Kerdpanich A, Huang LM, Silas P, Qaqundah P, Blatter M, Jeanfreau R, Lei P, Jain V, El Idrissi M, Feng Y, Innis B, Peeters M, Devaster JM. A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 2013 Sep;9(9):1978-88. doi: 10.4161/hv.25363. Epub 2013 Jun 19.
PubMed 23782962

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children
ClinicalTrials.gov ID: NCT00764790
Acronym / sponsor ID: 111751
Conditions: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,317 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Oct 2008
Primary completion: 5 Mar 2009 (actual)
Study completion: 1 Jun 2009 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 27 Jul 2010

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Fluarix Dose A Group	Experimental	Biological: FluarixSubjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Fluarix Dose B Group	Experimental	Biological: FluarixSubjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Fluzone Group	Active comparator	Biological: FluzoneSubjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Who may qualify

Ages: 6 to 35 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject's parent/guardian.

Key exclusion criteria (7 listed)

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.

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
FluarixOne (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.	Biological	Fluarix Dose A Group, Fluarix Dose B Group
FluzoneOne (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.	Biological	Fluzone Group

Primary outcome

Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
Time frame: Day 0 (PRE), Day 28 or Day 56 (POST)
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Number of Subjects Who Seroconverted
Time frame: Day 28 or Day 56
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

7 secondary outcomes

Number of Seroprotected Subjects
Time frame: Day 0 (PRE), Day 28 or Day 56 (POST)
Seroconversion Factor
Time frame: Day 28 or Day 56
Number of Subjects Reporting Solicited Local Symptoms
Time frame: During a 4-day follow-up period after vaccination
Number of Subjects Reporting Solicited General Symptoms
Time frame: During a 4-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time frame: During a 28-day follow-up period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)
Time frame: During the entire study (Day 0 until Month 6)
Number of Subjects Reporting Rare Serious Events
Time frame: During the entire study (Day 0 until Month 6)

Results and safety

Results posted to the registry on 27 Jul 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
Fluarix Dose A Group	1,107	1,069
Fluarix Dose B Group	1,106	1,065
Fluzone Group	1,104	1,074

Primary outcome: Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains

Time frame: Day 0 (PRE), Day 28 or Day 56 (POST). Geometric mean (95% Confidence Interval). Unit: titre

Measure	Fluarix Dose A Group n = 1018	Fluarix Dose B Group n = 1016	Fluzone Group n = 1031
A/Brisbane (PRE)	10.4 (9.7 to 11.1)	10.6 (9.8 to 11.4)	10.9 (10.1 to 11.7)
A/Brisbane (POST)	106.1 (93.8 to 120.1)	131.6 (116.3 to 148.9)	232.4 (214.0 to 252.3)
A/Uruguay (PRE)	12.1 (11.1 to 13.2)	11.2 (10.2 to 12.2)	11.6 (10.7 to 12.7)
A/Uruguay (POST)	125.6 (113.3 to 139.3)	158.7 (143.9 to 175.2)	280.3 (260.3 to 301.9)
B/Florida (PRE)	8.4 (7.9 to 9.0)	8.9 (8.3 to 9.6)	8.3 (7.7 to 8.8)
B/Florida (POST)	113.0 (103.4 to 123.4)	164.4 (150.2 to 180.1)	176.4 (162.3 to 191.7)

Population analysed: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Primary outcome: Number of Subjects Who Seroconverted

Time frame: Day 28 or Day 56. Count of participants. Unit: Participants

Measure	Fluarix Dose A Group n = 1017	Fluarix Dose B Group n = 1013	Fluzone Group n = 1030
A/Brisbane	636	699	929
A/Uruguay	747	808	988
B/Florida	812	864	904

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluarix Dose A Group	35 of 1,107 (3.2%)	805 of 1,107 (72.7%)	Not reported
Fluarix Dose B Group	29 of 1,106 (2.6%)	791 of 1,106 (71.5%)	Not reported
Fluzone Group	31 of 1,104 (2.8%)	808 of 1,104 (73.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29465480Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
Derived from this study: PubMed 23782962Pavia-Ruz N, Angel Rodriguez Weber M, Lau YL, Nelson EA, Kerdpanich A, Huang LM, Silas P, Qaqundah P, Blatter M, Jeanfreau R, Lei P, Jain V, El Idrissi M, Feng Y, Innis B, Peeters M, Devaster JM. A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 2013 Sep;9(9):1978-88. doi: 10.4161/hv.25363. Epub 2013 Jun 19.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

69 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluarix and Fluzone in people with Influenza, run by GlaxoSmithKline at 69 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Hong Kong, Mexico, Taiwan, Thailand. 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 27 Jul 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 Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains (time frame: Day 0 (PRE), Day 28 or Day 56 (POST)). 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 NCT00764790, which also lists 2 linked publications.

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 31 Jul 2018.