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InfluenzaPhase 3NCT01196975

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

A Phase 3 study testing Quadrivalent seasonal influenza vaccine GSK2282512A, FluLavalTM-VB and FluLavalTM-YB in people with Influenza, run by GlaxoSmithKline at 12 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines. This study will also evaluate the lot-to-lot consistency of three vaccine lots. 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?
Quadrivalent seasonal influenza vaccine GSK2282512A, FluLavalTM-VB and FluLavalTM-YB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,707 participants
Where
12 sitesin 3 countries
Study dates
1 Oct 2010to 24 Jun 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

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A male or female 18 years of age or older, in stable health, as established by medical history and physical examination before entering into the study.
  • Written informed consent obtained from the subject.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
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  • - 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

  • Use of an investigational / non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period.
  • Planned administration or administration of a licensed vaccine within 30 days before study vaccination.
  • Prior receipt of 2010/2011 influenza vaccine.
  • Receipt of any investigational or approved influenza vaccine within six months of the first study visit.
  • Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
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  • History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable / unlikely to provide accurate safety reports.
  • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
  • Presence of significant uncontrolled chronic medical or neuropsychiatric illness, based on history and physical examination
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine/product dose.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Fever at the time of enrolment.
  • Acute disease at the time of enrolment
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

United States6 sites

  • GSK Investigational Site

    Elkridge, Maryland, 21075

  • GSK Investigational Site

    Endwell, New York, 13760

  • GSK Investigational Site

    Jefferson Hills, Pennsylvania, 15025

  • GSK Investigational Site

    Mesa, Arizona, 85213

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

Canada3 sites

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Québec, Quebec, G1V 4M6

  • GSK Investigational Site

    Surrey, British Columbia, V3R 8P8

Other trials in Canada

Mexico3 sites

  • GSK Investigational Site

    Cuernavaca, Morelos

  • GSK Investigational Site

    Durango, 3400

  • GSK Investigational Site

    Estado de México, 55075

Other trials in Mexico

About this study

Official title: Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Quadrivalent Influenza Vaccine FLU Q-QIV (GSK2282512A) When Administered Intramuscularly to Adults 18 Years of Age and Older

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines.

This study will also evaluate the lot-to-lot consistency of three vaccine lots.

Conditions
Influenza
Being tested
Quadrivalent seasonal influenza vaccine GSK2282512A, FluLavalTM-VB, FluLavalTM-YB
Keywords
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.

  • Quadrivalent seasonal influenza vaccine GSK2282512ABiological

    Also called GSK2282512A

    Single intramuscular dose

  • FluLavalTM-VBBiological

    Also called FluLavalTM containing the Victoria B flu strain, FluLaval®-VB, Victoria Strain FluLaval vaccine

    Single intramuscular dose

  • FluLavalTM-YBBiological

    Also called FluLavalTM containing the Yamagata B flu strain, FluLaval®-YB

    Single intramuscular dose

Study groups in NCT01196975
Study groupRoleWhat they receive
GSK2282512A 1 GroupExperimentalSubjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
GSK2282512A 2 GroupExperimentalSubjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
GSK2282512A 3 GroupExperimentalSubjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Victoria Strain FluLaval GroupActive comparatorSubjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: FluLavalTM-VB
Yamagata Strain FluLaval GroupActive comparatorSubjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: FluLavalTM-YB

What is being measured

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

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.

    Measured: At Day 0 (D0) and at Day 21 (D21) post vaccination.

Secondary outcomes (24)

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Measured: At Day 0 (D0) and at Day 21 (D21) post vaccination.

  2. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Measured: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

  3. Number of Subjects With Medically-attended Adverse Events (MAEs)

    Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE.

    Measured: From the beginning of the study until study end (from Day 0 to Day 180)

  4. Number of Subjects With Related Medically-attended Adverse Events (MAEs)

    Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.

    Measured: From the beginning of the study until study end (from Day 0 to Day 180) .

  5. Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)

    Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.

    Measured: From the beginning of the study until study end (from Day 0 to Day 180) .

  6. Number of Subjects With Any and Related Serious Adverse Events (SAEs)

    Serious adverse events (SAEs) assessed include medical occurrences that result 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: From the beginning of the study until study end (from Day 0 to Day 180)

  7. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Measured: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

  8. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains

    Measured: At Day 0 (D0) and at Day 21 (D21) after vaccination.

  9. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Measured: At Day 0 (D0) and at Day 21 (D21) after vaccination.

  10. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Measured: At Day 0 (D0) and at Day 21 (D21) after vaccination

  11. Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Measured: At Day 21 (D21) after vaccination.

  12. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.

    Measured: At Day 21 (D21) after vaccination

  13. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Measured: At Day 0 (D0) and at Day 21 (D21) post vaccination.

  14. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.

    Measured: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.

  15. Number of Seroconverted Subjects Against 4 Strains of Influenza

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.

    Measured: At Day 21 (D21) after vaccination.

  16. Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Measured: At Day 21 (D21) after vaccination.

  17. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.

    Measured: At Day 21 (D21) post vaccination.

  18. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.

    Measured: At Day 21 (D21) post vaccination.

  19. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

    Measured: Within the 7-day (Days 0-6) follow-up period after vaccination

  20. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature - oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.

    Measured: Within the 7-day (Days 0-6) follow-up period after vaccination

  21. Number of Subjects With Any, Grade 3 and Related 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. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.

    Measured: Within the 21-day (Days 0-20) follow-up period after vaccination

  22. Number of Days With Solicited Local Symptoms After Vaccination.

    Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.

    Measured: Within the 7-day follow-up period after vaccination (Days 0-6)

  23. Number of Days With Solicited General Symptoms After Vaccination

    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.

    Measured: Within the 7-day follow-up period after vaccination (Days 0-6)

  24. Number of Days With Unsolicited Adverse Events (AEs) After Vaccination

    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. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.

    Measured: Within the 21-day (Days 0-20) follow-up period post vaccination

Timeline

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

  1. First posted9 Sep 2010 (estimated)
  2. Study start1 Oct 2010
  3. Primary completion25 Jan 2011
  4. Study completion24 Jun 2011

Resources

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
Participant, Investigator
Enrolment
1,707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01196975
Sponsor's protocol ID
112963
Status last verified
Sep 2016
First submitted
7 Sep 2010
Last updated
21 Sep 2018
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

  • Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, Aranza Doniz C, Chandrasekaran V, Dewe W, Liu A, Innis BL, Jain VK. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged >/=18 years: a phase III, randomized trial. Vaccine. 2014 Mar 14;32(13):1480-7. doi: 10.1016/j.vaccine.2014.01.022. Epub 2014 Jan 28.

    PubMed 24486352

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent seasonal influenza vaccine GSK2282512A, FluLavalTM-VB and FluLavalTM-YB in people with Influenza, run by GlaxoSmithKline at 12 sites in 3 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 9 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 21 Sep 2018. 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, Canada, Mexico. 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 24 Dec 2012). 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?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease (time frame: At Day 0 (D0) and at Day 21 (D21) post vaccination.). 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 NCT01196975, 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 21 Sep 2018.

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