Influenza Clinical Trial
Official title:
Observer Blind Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals Influenza Vaccine GSK576389A Administered to Adults Over 65 Years Previously Vaccinated With the Same Vaccine, Compared to Fluarix™
Verified date | April 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
Status | Completed |
Enrollment | 1252 |
Est. completion date | June 4, 2008 |
Est. primary completion date | December 21, 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. - Written informed consent obtained from the subject. - Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study. - If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. - Male or female subjects who participated in the 104888 study (NCT00377585) and were enrolled in the >= 65 years age group or in the 18-40 years age group . Exclusion Criteria: - Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. - Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination - Planned administration of an influenza vaccine other than the study vaccines during the entire study period - Any vaccination against influenza since January 2007 - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - History of hypersensitivity to a previous dose of influenza vaccine - History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) - Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests - Acute disease at the time of enrolment - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period - Any medical conditions in which IM injections are contraindicated - Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions. |
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Gent | |
Germany | GSK Investigational Site | Augsburg | Bayern |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Haag | Bayern |
Germany | GSK Investigational Site | Hoehenkirchen-Siegertsbrunn | Bayern |
Germany | GSK Investigational Site | Langquaid | Bayern |
Germany | GSK Investigational Site | Leipzig | Sachsen |
Germany | GSK Investigational Site | Messkirch | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Ruedersdorf | Brandenburg |
Norway | GSK Investigational Site | Bekkestua | |
Norway | GSK Investigational Site | Bergen | |
Norway | GSK Investigational Site | Elverum | |
Norway | GSK Investigational Site | Fredrikstad | |
Norway | GSK Investigational Site | Hamar | |
Norway | GSK Investigational Site | Haugesund | |
Norway | GSK Investigational Site | Skien | |
United States | GSK Investigational Site | Carnegie | Pennsylvania |
United States | GSK Investigational Site | Chaska | Minnesota |
United States | GSK Investigational Site | Clearwater | Florida |
United States | GSK Investigational Site | Coral Gables | Florida |
United States | GSK Investigational Site | Erie | Pennsylvania |
United States | GSK Investigational Site | Milford | Massachusetts |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Poughkeepsie | New York |
United States | GSK Investigational Site | Somers Point | New Jersey |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Belgium, Germany, Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. | During a 7-day follow-up period after vaccination | |
Primary | Duration of Solicited Local Adverse Events | Duration was expressed as the median number of days the symptom was experienced. | During a 7-day follow-up period after vaccination | |
Primary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs) | Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination. | During a 7-day follow-up period after vaccination | |
Primary | Duration of Solicited General Adverse Events | Duration was expressed as the median number of days the symptom was experienced. | During a 7-day follow-up period after vaccination | |
Primary | Number of Subjects Reporting 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 AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination. | During a 21-day follow-up period after vaccination | |
Secondary | Number of Subjects With Any and Related Serious Adverse Events (SAEs) | 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. | During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179) | |
Secondary | Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs) | Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits. | During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179) | |
Secondary | Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains | Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | At Days 0 and 21 | |
Secondary | Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | At Day 21 | |
Secondary | Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0. | At Day 21 | |
Secondary | Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | At Days 0 and 21 | |
Secondary | Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers | Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-a) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker | Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-a) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-? and Another Immune Marker | Results are presented as the geometric mean number of IFN-? -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-a). | At Day 0 and 21 | |
Secondary | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker | Results are presented as the geometric mean number of IFN-? -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-a) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-a and Another Immune Marker | Results are presented as the geometric mean number of IFN-? -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers | Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-a) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker | Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-a) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-? and Another Immune Marker | Results are presented as the geometric mean number of IFN-? -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-a). | At Day 0 and 21 | |
Secondary | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker | Results are presented as the geometric mean number of IFN-? -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-a) and interferon gamma (IFN-?). | At Day 0 and 21 | |
Secondary | Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-a and Another Immune Marker | Results are presented as the geometric mean number of IFN-? -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-?). | At Day 0 and 21 |
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