AzTrials
AzTrials

InfluenzaPhase 3NCT00979602

Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older

A Phase 3 study testing GSK2340274A and GSK2340273A in people with Influenza, run by GlaxoSmithKline at 38 sites in 2 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

The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. 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?
GSK2340274A and GSK2340273A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,048 participants
Where
38 sitesin 2 countries
Study dates
9 Nov 2009to 1 Feb 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.
  • Written informed consent obtained from the subject.
  • Male and female adults, >= 18 years of age at the time of the first vaccination.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Safety laboratory test results within the parameters specified in the protocol.
  • 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 as demonstrated by signature on the informed consent document.
Show all 12Show fewer
  • 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:
  • has practiced adequate contraception for 30 days prior to vaccination; and
  • has a negative pregnancy test on the day of first 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

  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
  • Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
  • With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
  • Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.
  • Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).
  • Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
Show all 20Show fewer
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
  • With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
  • Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.
  • Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination.
  • Lactating or nursing women.

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States25 sites

  • GSK Investigational Site

    Binghamton, New York, 13901

  • GSK Investigational Site

    Camillus, New York, 13031

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Delray Beach, Florida, 33484

  • GSK Investigational Site

    Erie, Pennsylvania, 16506

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Mesa, Arizona, 85213

  • GSK Investigational Site

    Milford, Massachusetts, 01757

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Phoenix, Arizona, 85028

  • GSK Investigational Site

    Rockville, Maryland, 20850

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Willoughby Hills, Ohio, 44094

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada13 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Coquitlam, British Columbia, V3K 3P4

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    London, Ontario, N5W 6A2

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4G2

  • GSK Investigational Site

    Québec, Quebec, G1E 7G9

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    St-Romulad, Quebec, G6W 5M6

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

Other trials in Canada

About this study

Official title: A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older

The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

Read the detailed description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Conditions
Influenza
Being tested
GSK2340274A, GSK2340273A
Keywords
GSK Bio's influenza vaccine GSK2340274A, Influenza Vaccines, GSK Bio's influenza vaccine GSK2340273A, influenza infection
Medical subject headings
Influenza, Human

What participants receive

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

  • GSK2340274ABiological

    One intramuscular injection

  • GSK2340273ABiological

    One intramuscular injection

Study groups in NCT00979602
Study groupRoleWhat they receive
GSK2340274A GroupExperimentalHealthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Receives: Biological: GSK2340274A
GSK2340273A GroupExperimentalHealthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
Receives: Biological: GSK2340273A

What is being measured

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

  1. Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.

    Measured: At Day 21

  2. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 0

  3. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 21

  4. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.

    Measured: At Day 21

  5. Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases

    The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.

    Measured: From Day 14 post-vaccination up to study end (at Day 385)

Secondary outcomes (22)

  1. Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.

    The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Days 0 and 21

  2. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Days 0 and 21

  3. Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 42

  4. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 42

  5. Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 182

  6. Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 182

  7. Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 42

  8. Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 182

  9. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 42

  10. Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain

    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

    Measured: At Day 182

  11. Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.

    Measured: At Day 42

  12. Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain

    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.

    Measured: At Day 182

  13. Number of A/California Influenza Related Cases

    Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.

    Measured: From Day 0 up to the end of ILI surveillance (Day 385)

  14. Number of ILI Symptoms in All Reported ILI Cases

    Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.

    Measured: From Day 0 up to the end of ILI surveillance (Day 385)

  15. Number of ILI Symptoms in All Reported ILI Cases

    Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.

    Measured: From Day 14 post-vaccination through the end of ILI surveillance (Day 385)

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

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

    Measured: During the 7-day (Days 0-6) post-vaccination period

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

    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

    Measured: During the 7-day (Days 0-6) post-vaccination period

  18. Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels

    Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).

    Measured: At Days 7 and 21

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

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

    Measured: Throughout the entire study period (Day 0 - Day 385)

  20. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)

    Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

    Measured: Throughout the entire study period (Day 0 - Day 385)

  21. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    An unsolicited AE covers 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 and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

    Measured: Within the 42-day (Days 0-41) post-vaccination period

  22. Number of Subjects With 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 or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).

    Measured: Throughout the entire study period (Day 0 - Day 385)

Timeline

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

  1. First posted18 Sep 2009 (estimated)
  2. Study start9 Nov 2009
  3. Primary completion10 Jan 2011
  4. Study completion1 Feb 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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
4,048 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979602
Sponsor's protocol ID
113480
Status last verified
Mar 2018
First submitted
17 Sep 2009
Last updated
21 Mar 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

  • Yang WH, Dionne M, Kyle M, Aggarwal N, Li P, Madariaga M, Godeaux O, Vaughn DW. Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: an observer-blind, randomized trial. Vaccine. 2013 Sep 13;31(40):4389-97. doi: 10.1016/j.vaccine.2013.07.007. Epub 2013 Jul 12.

    PubMed 23856331

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK2340274A and GSK2340273A in people with Influenza, run by GlaxoSmithKline at 38 sites in 2 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 12 inclusion and 20 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, 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 21 Sep 2017). 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?

Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain (time frame: At Day 21). The study lists 5 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 NCT00979602, 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 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT00979602 | AzTrials