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

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ClinicalTrials.gov Identifier: NCT01204671

Recruitment Status : Completed

First Posted : September 17, 2010

Results First Posted : June 17, 2013

Last Update Posted : September 24, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief 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. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Influenza vaccine GSK2321138A Biological: FluarixTM Biological: Influenza vaccine GSK2604409A	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4659 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
Study Start Date :	October 4, 2010
Actual Primary Completion Date :	June 6, 2011
Actual Study Completion Date :	June 6, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: GSK2321138A Lot 1 Group Subjects 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.	Biological: Influenza vaccine GSK2321138A One intramuscular injection
Experimental: GSK2321138A Lot 2 Group Subjects 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.	Biological: Influenza vaccine GSK2321138A One intramuscular injection
Experimental: GSK2321138A Lot 3 Group Subjects 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.	Biological: Influenza vaccine GSK2321138A One intramuscular injection
Active Comparator: Fluarix Group Subjects 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.	Biological: FluarixTM One intramuscular injection
Active Comparator: GSK2604409A Group Subjects 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.	Biological: Influenza vaccine GSK2604409A One intramuscular injection

Outcome Measures

Primary Outcome Measures :

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) ]
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.
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease [ Time Frame: At Day 21 (D 21) ]
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.

Secondary Outcome Measures :

Number of Seropositive Subjects Against 4 Strains of Influenza Disease [ Time Frame: At Day 0 (D 0), and at Day 21 (D 21) ]
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.
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease [ Time Frame: At Day 0 (D 0), and at Day 21 (D 21) ]
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.
Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease [ Time Frame: At Day 21 (D 21) ]
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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ]
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.
Number of Days With Solicited Local Symptoms [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ]
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ]
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.
Number of Days With Solicited General Symptoms [ Time Frame: Within the 7-day (Days 0-6) follow-up period after vaccination ]
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)].
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 21-day (Days 0-20) follow-up period after vaccination ]
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.
Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) [ Time Frame: From the beginning of the study (Day 0) to study end (Day 180) ]
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.
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) [ Time Frame: From the beginning of the study (Day 0) to study end (Day 180) ]
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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ Time Frame: From the beginning of the study (Day 0) to study end (Day 180) ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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:
- 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

Exclusion Criteria:

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.
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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204671

Locations

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United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Kansas
GSK Investigational Site
Newton, Kansas, United States, 67114
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40509
United States, Maryland
GSK Investigational Site
Columbia, Maryland, United States, 21045
United States, Massachusetts
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, North Carolina
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Germany
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72074
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
GSK Investigational Site
Haag, Bayern, Germany, 83527
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Dresden, Sachsen, Germany, 01277
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Dresden, Sachsen, Germany, 01309
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 13086
Korea, Republic of
GSK Investigational Site
Guro Gu, Korea, Republic of, 152703
GSK Investigational Site
Gyeonggi, Korea, Republic of, 442-723
GSK Investigational Site
Incheon, Korea, Republic of, 400-711
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
Romania
GSK Investigational Site
Braila, Romania, 810384
GSK Investigational Site
Brasov, Romania, 500260
GSK Investigational Site
Bucharest, Romania, 020142
GSK Investigational Site
Bucharest, Romania, 062289
GSK Investigational Site
Bucharest, Romania, 077190
GSK Investigational Site
Galati, Romania, 800494
GSK Investigational Site
Galati, Romania, 800578
GSK Investigational Site
Pantelimon, Romania, 77145
GSK Investigational Site
Ploiesti, Romania, 100172
Spain
GSK Investigational Site
Balenyà (Barcelona), Spain, 08550
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Centelles, Spain
GSK Investigational Site
La Roca Del Valles (Barcelona), Spain, 08430
GSK Investigational Site
Vic/ Barcelona, Spain, 08500
Taiwan
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taipei, Taiwan

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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