Last updated: 11/03/2018 12:08:08
Evaluation of safety and immunogenicity of GSK Biologicals’ influenza vaccine GSK2186877A in adults 65 years and older
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Observer-blind safety and immunogenicity study of GlaxoSmithKline Biologicals’ influenza vaccine GSK2186877A when administered to elderly subjects.
Trial description: The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ influenza vaccine GSK2186877A in adults 65 year of age and older.This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)
Timeframe: Day 0-6
Duration of solicited local AEs
Timeframe: Day 0-6
Number of subjects reporting any, grade 3 and related solicited general AEs
Timeframe: Day 0-6
Duration of solicited general AEs
Timeframe: Day 0-6
Number of subjects reporting any, grade 3 and related unsolicited AEs
Timeframe: Day 0-20
Number of subjects reporting any, grade 3 and related AEs with a medically attended visit between Day 0 to 20
Timeframe: Day 0-20
Number of subjects reporting any, grade 3 and related AEs with a medically attended visit between Day 21 to 179
Timeframe: Day 21-179
Number of subjects reporting AEs of specific interest (AESI) including autoimmune disease (AID)
Timeframe: Day 0-179
Number of subjects reporting any and related serious adverse events (SAEs) between Day 0 to Day 20
Timeframe: Day 0-20
Number of subjects reporting any and related serious adverse events (SAEs) between Day 21 to Day 179
Timeframe: Day 21-179
Number of subjects reporting any and related serious adverse events (SAEs) from Day 180 to Day 209
Timeframe: Day 180 to Day 209
Secondary outcomes:
Haemagglutination Inhibition (HI) antibody titers at days 0 and 21
Timeframe: At Day 0 and 21
HI antibody titers at Day 180
Timeframe: Day 180
The number of subjects seropositive to HI antibodies at Day 0 and 21
Timeframe: At Day 0 and 21
The number of subjects seropositive to HI antibodies at Day 180
Timeframe: Day 180
The number of subjects seroconverted to HI antibodies at Day 21
Timeframe: Day 21
The number of subjects seroconverted to HI antibodies at Day 180
Timeframe: Day 180
HI antibody seroconversion factor (SCF) at Day 21
Timeframe: Day 21
HI antibody SCF at Day 180
Timeframe: Day 180
The number of subjects seroprotected to HI antibodies at Day 0 and Day 21
Timeframe: At Day 0 and 21
The number of subjects seroprotected to HI antibodies at Day 180
Timeframe: Day 180
The geometric mean (GM) number of influenza specific Cluster of Differentiation 4 (CD4) T-cells per million CD4 T-cells for each vaccine strain expressing at least two different markers or expressing different combinations of markers at Days 0 and 21
Timeframe: At Day 0 and 21
Interventions:
Biological/vaccine: GSK Bio's influenza vaccine GSK2186877A
Biological/vaccine: Fluarix
Enrollment:
526
Observational study model:
Not applicable
Primary completion date:
2009-15-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK2186877A, SB218352
Collaborators
Not applicable
Study date(s)
October 2008 to May 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
- 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.
- 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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
- Written informed consent obtained from the subject.
- Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- Female subjects must be of non-childbearing potential.
Exclusion criteria:
- 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.
- 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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
- Chronic administration (defined as 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.
- History of hypersensivity 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 IM injections are contraindicated.
- Lactating female, female planning to become pregnant or planning to discontinue contraceptive precautions.
Trial location(s)
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Rudersberg, Baden-Wuerttemberg, Germany, 73635
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-15-05
Actual study completion date
2009-15-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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