InfluenzaPhase 3NCT01153685

Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

A Phase 3 study testing Fluviral® in people with Influenza, run by GlaxoSmithKline at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years. 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?: Fluviral®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteCanada
Study dates: 9 Jul 2010to 31 Jul 2010
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

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject
Male and female adults, 18 to 60 years of age and over 60 years of age.
Satisfactory baseline medical assessment by history and physical examination
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Female subjects of non-childbearing potential may be enrolled in the study.

Show all 10Show fewer

Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

Participation in previous year's (2009) Fluviral registration study
Administration of any influenza vaccine within 6 months preceding the study start (35 or more subjects in the >60 year old age stratum will be recruited from among those who did NOT receive any inactivated influenza vaccine in 2009-2010 season, i.e. seasonal TIV or pandemic H1N1v).
Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.
Clinically or virologically confirmed influenza infection within 1 year preceding the study start.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <38.0°C.

Show all 29Show fewer

Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as:
Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or
Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or
Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.
Any confirmed or suspected immunosuppressive condition including:
History of human immunodeficiency virus (HIV) infection,
Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
History of renal impairment.
History of hepatic dysfunction due to hepatitis B, C or toxins including alcohol.
Complicated insulin-dependent diabetes mellitus.
Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
Receipt of systemic glucocorticoids (prednisone >= 20 mg/day for more than 14 consecutive days) within 1 month of study enrollment, or any cytotoxic or immunosuppressive drugs within six months of study enrollment. Inhaled and topical steroids are allowed.
A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
Presence of an active neurological disorder.
History of chronic alcohol consumption and/or drug abuse.
Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Any known or suspected allergy to any constituent of Fluviral (egg protein, thimerosal) and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury (such as thimerosal).
A history of severe adverse reaction to a previous influenza vaccination.
Pregnant and/or lactating/nursing female.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' (GSK1536489A) Trivalent Split Virion Influenza Vaccine Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years.

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

Conditions: Influenza
Being tested: Fluviral®
Keywords: Fluviral®Influenza
Medical subject headings: Influenza, Human

What participants receive

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

Fluviral®Biological
Intramuscular injection, one dose

Study groups in NCT01153685
Study group	Role	What they receive
Fluviral A Group	Experimental	Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluviral®
Fluviral B Group	Experimental	Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Fluviral®

What is being measured

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

Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Measured: At Day 0 before vaccination
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Measured: At Day 21 after vaccination
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
Measured: At Day 0 before vaccination
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
Measured: At Day 21 after vaccination
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.
A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Measured: At Day 21 after vaccination
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).
Measured: At Day 21 after vaccination

Secondary outcomes (4)

Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.
Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)
Measured: During a 4-days (Day 0-3) follow-up period after vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.
Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.
Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination.
Measured: Within the 21-day post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Within the 21-day post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period

Timeline

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

9 Jul 201031 Jul 2010

First posted30 Jun 2010 (estimated)
Study start9 Jul 2010
Primary completion31 Jul 2010
Study completion31 Jul 2010

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 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01153685
Sponsor's protocol ID: 110628
Status last verified: Sep 2016
First submitted: 29 Jun 2010
Last updated: 8 Jun 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

Jain VK, Chandrasekaran V, Wang L, Li P, Liu A, Innis BL. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine. BMC Infect Dis. 2014 Mar 10;14:133. doi: 10.1186/1471-2334-14-133.
PubMed 24606983

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

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' (GSK1536489A) Trivalent Split Virion Influenza Vaccine Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years.
ClinicalTrials.gov ID: NCT01153685
Acronym / sponsor ID: 110628
Conditions: Influenza
Keywords: Fluviral®Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Jul 2010
Primary completion: 31 Jul 2010 (actual)
Study completion: 31 Jul 2010 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 17 Nov 2011

Clinical summary

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

This study is designed to test the safety and immunogenicity of Fluviral® (2010 - 2011 Season) in adults aged 18 to 60 years and over 60 years.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fluviral A Group	Experimental	Biological: Fluviral®Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Fluviral B Group	Experimental	Biological: Fluviral®Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.

Who may qualify

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

Key inclusion criteria (10 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject
Male and female adults, 18 to 60 years of age and over 60 years of age.
Satisfactory baseline medical assessment by history and physical examination
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Key exclusion criteria (29 listed)

Participation in previous year's (2009) Fluviral registration study
Administration of any influenza vaccine within 6 months preceding the study start (35 or more subjects in the >60 year old age stratum will be recruited from among those who did NOT receive any inactivated influenza vaccine in 2009-2010 season, i.e. seasonal TIV or pandemic H1N1v).
Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort.
Clinically or virologically confirmed influenza infection within 1 year preceding the study start.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.

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
Fluviral®Intramuscular injection, one dose	Biological	Fluviral A Group, Fluviral B Group

Primary outcome

Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.
Time frame: At Day 0 before vaccination
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.
Time frame: At Day 21 after vaccination
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.
Time frame: At Day 0 before vaccination
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.
Time frame: At Day 21 after vaccination
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.
Time frame: At Day 21 after vaccination
A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.
Time frame: At Day 21 after vaccination
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).

4 secondary outcomes

Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.
Time frame: During a 4-days (Day 0-3) follow-up period after vaccination.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within the 21-day post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Time frame: Within the 21-day post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period

Results and safety

Results posted to the registry on 17 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
Fluviral A Group	50	50
Fluviral B Group	70	70

Primary outcome: Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.

Time frame: At Day 0 before vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Fluviral A Group n = 49	Fluviral B Group n = 70
A/California (H1N1)	39.2 (24.0 to 63.8)	15.2 (11.1 to 21.0)
A/Victoria (H3N2)	14.1 (10.1 to 19.8)	13.0 (9.8 to 17.3)
B/Brisbane	22.7 (15.2 to 34.0)	28.0 (21.5 to 36.5)

Population analysed: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

Primary outcome: Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.

Time frame: At Day 21 after vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Fluviral A Group n = 49	Fluviral B Group n = 70
A/California (H1N1)	390.1 (293.8 to 518.1)	142.1 (105.1 to 192.0)
A/Victoria (H3N2)	185.6 (140.9 to 244.5)	183.7 (139.6 to 241.8)
B/Brisbane	260.6 (184.6 to 368.0)	248.6 (185.9 to 332.3)

Population analysed: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

Primary outcome: Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.

Time frame: At Day 0 before vaccination. Number. Unit: Subjects

Measure	Fluviral A Group n = 49	Fluviral B Group n = 70
A/California (H1N1)	29	22
A/Victoria (H3N2)	15	17
B/Brisbane	21	35

Population analysed: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

Primary outcome: Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.

Time frame: At Day 21 after vaccination. Number. Unit: Subjects

Measure	Fluviral A Group n = 49	Fluviral B Group n = 70
A/California (H1N1)	49	62
A/Victoria (H3N2)	48	65
B/Brisbane	47	69

Population analysed: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluviral A Group	2 of 50 (4%)	45 of 50 (90%)	Not reported
Fluviral B Group	0 of 70 (0%)	30 of 70 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24606983Jain VK, Chandrasekaran V, Wang L, Li P, Liu A, Innis BL. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine. BMC Infect Dis. 2014 Mar 10;14:133. doi: 10.1186/1471-2334-14-133.
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.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluviral® in people with Influenza, run by GlaxoSmithKline at 1 site in Canada.

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 10 inclusion and 29 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 17 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) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. (time frame: At Day 0 before vaccination). The study lists 6 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 NCT01153685, 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 8 Jun 2018.