AzTrials
AzTrials

InfluenzaPhase 3NCT01204671

Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

A Phase 3 study testing Influenza vaccine GSK2321138A, FluarixTM and Influenza vaccine GSK2604409A in people with Influenza, run by GlaxoSmithKline at 42 sites in 6 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 assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. 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?
Influenza vaccine GSK2321138A, FluarixTM and Influenza vaccine GSK2604409A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,659 participants
Where
42 sitesin 6 countries
Study dates
4 Oct 2010to 6 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

  • A male or female 18 years of age or older at the time of the first vaccination
  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
  • 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:
Show all 9Show fewer
  • - has practiced adequate contraception for 30 days prior to vaccination,
  • - and has a negative urine 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 any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Administration of an influenza vaccine during the 6 months preceding entry into the study.
  • Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
  • Any contra-indication to intramuscular administration of the influenza vaccines.
  • History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Show all 15Show fewer
  • Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease and/or fever at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
  • Pregnant or lactating female.

Trial locations and contacts

42 sites in 6 countries.

42 sites in 6 countries

Germany12 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Dresden, Saxony, 01277

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Dresden, Saxony, 01309

  • GSK Investigational Site

    Finsterwalde, Brandenburg, 03238

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Freiberg, Saxony, 09599

  • GSK Investigational Site

    Haag, Bavaria, 83527

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72074

Other trials in Germany

United States10 sites

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    Erie, Pennsylvania, 16506

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Miami, Florida, 33143

  • GSK Investigational Site

    Milford, Massachusetts, 01757

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Newton, Kansas, 67114

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

Other trials in United States

Romania9 sites

  • GSK Investigational Site

    Brăila, 810384

  • GSK Investigational Site

    Brasov, 500260

  • GSK Investigational Site

    Bucharest, 020142

  • GSK Investigational Site

    Bucharest, 062289

  • GSK Investigational Site

    Bucharest, 077190

  • GSK Investigational Site

    Galati, 800494

  • GSK Investigational Site

    Galati, 800578

  • GSK Investigational Site

    Pantelimon, 77145

  • GSK Investigational Site

    Ploieşti, 100172

Other trials in Romania

Spain5 sites

  • GSK Investigational Site

    Balenyà (Barcelona), 08550

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Centelles

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430

  • GSK Investigational Site

    Vic/ Barcelona, 08500

Other trials in Spain

South Korea4 sites

  • GSK Investigational Site

    Guro Gu, 152703

  • GSK Investigational Site

    Gyeonggi-do, 442-723

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Seoul, 150-719

Other trials in South Korea

Taiwan2 sites

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei

Other trials in Taiwan

About this study

Official title: Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

Conditions
Influenza
Being tested
Influenza vaccine GSK2321138A, FluarixTM, Influenza vaccine GSK2604409A
Keywords
influenza infection, GSK Biologicals influenza vaccine GSK2321138A
Medical subject headings
Influenza, Human

What participants receive

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

  • Influenza vaccine GSK2321138ABiological

    One intramuscular injection

  • FluarixTMBiological

    One intramuscular injection

  • Influenza vaccine GSK2604409ABiological

    One intramuscular injection

Study groups in NCT01204671
Study groupRoleWhat they receive
GSK2321138A Lot 1 GroupExperimentalSubjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Influenza vaccine GSK2321138A
GSK2321138A Lot 2 GroupExperimentalSubjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Influenza vaccine GSK2321138A
GSK2321138A Lot 3 GroupExperimentalSubjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Influenza vaccine GSK2321138A
Fluarix GroupActive comparatorSubjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: FluarixTM
GSK2604409A GroupActive comparatorSubjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Influenza vaccine GSK2604409A

What is being measured

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

  1. Titers for 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. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

    Measured: At Day 0 (D 0), and at Day 21 (D 21)

  2. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease

    A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

    Measured: At Day 21 (D 21)

Secondary outcomes (11)

  1. Number of Seropositive Subjects Against 4 Strains of Influenza Disease

    A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

    Measured: At Day 0 (D 0), and at Day 21 (D 21)

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

    A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

    Measured: At Day 0 (D 0), and at Day 21 (D 21)

  3. Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease

    Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

    Measured: At Day 21 (D 21)

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

    Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. 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

  5. Number of Days With Solicited Local Symptoms

    Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.

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

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

    Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.

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

  7. Number of Days With Solicited General Symptoms

    Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)].

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

  8. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

    Unsolicited AEs cover 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.

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

  9. Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)

    Medically-attended events (MAEs) refer to 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 MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

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

  10. 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 as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.

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

  11. 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. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.

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

Timeline

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

  1. First posted17 Sep 2010 (estimated)
  2. Study start4 Oct 2010
  3. Primary completion6 Jun 2011
  4. Study completion6 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,659 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204671
Sponsor's protocol ID
114269
Status last verified
Feb 2017
First submitted
16 Sep 2010
Last updated
24 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

  • Kieninger D, Sheldon E, Lin WY, Yu CJ, Bayas JM, Gabor JJ, Esen M, Fernandez Roure JL, Narejos Perez S, Alvarez Sanchez C, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/=18 years. BMC Infect Dis. 2013 Jul 24;13:343. doi: 10.1186/1471-2334-13-343.

    PubMed 23883186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza vaccine GSK2321138A, FluarixTM and Influenza vaccine GSK2604409A in people with Influenza, run by GlaxoSmithKline at 42 sites in 6 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 15 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 24 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 42 sites in Germany, United States, Romania, Spain, South Korea and 1 more country. 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 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease (time frame: At Day 0 (D 0), and at Day 21 (D 21)). 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 NCT01204671, 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 24 Sep 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