Influenza Clinical Trial
Official title:
Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
NCT number | NCT01204671 |
Other study ID # | 114269 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 4, 2010 |
Est. completion date | June 6, 2011 |
Verified date | February 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4659 |
Est. completion date | June 6, 2011 |
Est. primary completion date | June 6, 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Augsburg | Bayern |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Dresden | Sachsen |
Germany | GSK Investigational Site | Finsterwalde | Brandenburg |
Germany | GSK Investigational Site | Frankfurt am Main | Hessen |
Germany | GSK Investigational Site | Freiberg | Sachsen |
Germany | GSK Investigational Site | Haag | Bayern |
Germany | GSK Investigational Site | Mainz | Rheinland-Pfalz |
Germany | GSK Investigational Site | Tuebingen | Baden-Wuerttemberg |
Korea, Republic of | GSK Investigational Site | Guro Gu | |
Korea, Republic of | GSK Investigational Site | Gyeonggi | |
Korea, Republic of | GSK Investigational Site | Incheon | |
Korea, Republic of | GSK Investigational Site | Seoul | |
Romania | GSK Investigational Site | Braila | |
Romania | GSK Investigational Site | Brasov | |
Romania | GSK Investigational Site | Bucharest | |
Romania | GSK Investigational Site | Bucharest | |
Romania | GSK Investigational Site | Bucharest | |
Romania | GSK Investigational Site | Galati | |
Romania | GSK Investigational Site | Galati | |
Romania | GSK Investigational Site | Pantelimon | |
Romania | GSK Investigational Site | Ploiesti | |
Spain | GSK Investigational Site | Balenyà (Barcelona) | |
Spain | GSK Investigational Site | Barcelona | |
Spain | GSK Investigational Site | Centelles | |
Spain | GSK Investigational Site | La Roca Del Valles (Barcelona) | |
Spain | GSK Investigational Site | Vic/ Barcelona | |
Taiwan | GSK Investigational Site | Taichung | |
Taiwan | GSK Investigational Site | Taipei | |
United States | GSK Investigational Site | Chandler | Arizona |
United States | GSK Investigational Site | Columbia | Maryland |
United States | GSK Investigational Site | Erie | Pennsylvania |
United States | GSK Investigational Site | Las Vegas | Nevada |
United States | GSK Investigational Site | Lexington | Kentucky |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Milford | Massachusetts |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | Newton | Kansas |
United States | GSK Investigational Site | Salisbury | North Carolina |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Germany, Korea, Republic of, Romania, Spain, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At Day 0 (D 0), and at Day 21 (D 21) | |
Primary | 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. | At Day 21 (D 21) | |
Secondary | 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. | At Day 0 (D 0), and at Day 21 (D 21) | |
Secondary | 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. | At Day 0 (D 0), and at Day 21 (D 21) | |
Secondary | 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. | At Day 21 (D 21) | |
Secondary | 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. | Within the 7-day (Days 0-6) follow-up period after vaccination | |
Secondary | Number of Days With Solicited Local Symptoms | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. | Within the 7-day (Days 0-6) follow-up period after vaccination | |
Secondary | 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. | Within the 7-day (Days 0-6) follow-up period after vaccination | |
Secondary | 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)]. | Within the 7-day (Days 0-6) follow-up period after vaccination | |
Secondary | 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. | Within the 21-day (Days 0-20) follow-up period after vaccination | |
Secondary | 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. | From the beginning of the study (Day 0) to study end (Day 180) | |
Secondary | 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. | From the beginning of the study (Day 0) to study end (Day 180) | |
Secondary | 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. | From the beginning of the study (Day 0) to study end (Day 180) |
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