Influenza Clinical Trial
Official title:
Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥67 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference.
Verified date | November 2016 |
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 study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.
Status | Completed |
Enrollment | 68 |
Est. completion date | December 12, 2007 |
Est. primary completion date | December 1, 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 67 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or GSK576389A vaccines in the 107973 study (NCT00386113). - Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. - A male or female aged >= 67 years at the time of re-vaccination. - Written informed consent obtained from the subject. - Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to vaccination, or planned use during the study period. - 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 21 days after vaccination. - Confirmed influenza infection since the date of previous vaccination. - Planned administration of an influenza vaccine other than the study vaccines during the entire study period. - Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine. - Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. - 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 clinical evaluation (medical history and medical history directed 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 administration of the study vaccine or planned administration during the study. - Any medical conditions in which intramuscular injections are contraindicated. |
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Gent |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms 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 Symptoms | Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade. | During a 7-day follow-up period after vaccination | |
Primary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms 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 39°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 Symptoms | Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. | 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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination. | During a 21-day follow-up period after vaccination | |
Primary | Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs) | Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination. | During a 21-day follow-up period after vaccination | |
Primary | Number of Subjects Reporting 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. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination. | Throughout the entire study (up to Day 21) | |
Secondary | Serum Haemagglutination 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 Seropositive for HI Antibodies Against Each of the Three Vaccine Strains | A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. 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 (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains | Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. | 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 to 1:40 that usually is accepted as indicating protection. | At Days 0 and 21 | |
Secondary | Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-a), Interferon gamma (IFN-?)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-a, or IFN-?) and least one other. | At Days 0 and 21 | |
Secondary | Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains | Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-a), Interferon gamma (IFN-?)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-a, or IFN-?) and least one other. | At Days 0 and 21 |
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