Last updated: 11/03/2018 12:08:23
Evaluation of the safety and immunogenicity of the influenza vaccine GSK2186877A in the elderly
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety and immunogenicity of the influenza vaccine GSK2186877A in the elderly
Trial description: The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Non-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 (MAEs) during Day 0 to Day 20
Timeframe: Day 0-20
Number of subjects reporting AEs of specific interest (AESI) including autoimmune diseases from Day 0 to Day 20
Timeframe: Day 0-20
Number of subjects reporting any and related serious adverse events (SAEs) from Day 0 to Day 20
Timeframe: Day 0-20
Secondary outcomes:
Number of subjects reporting any, grade 3 and related AEs with a medically attended visit (MAEs) between Day 21 and Day 179
Timeframe: Day 21-179
Number of subjects reporting AEs of specific interest (AESI) including autoimmune diseases between Day 21 and Day 364
Timeframe: Day 21-364.
Haemagglutination Inhibition (HI) antibody titers
Timeframe: Day 0-21
The number of subjects seropositive to HI antibodies
Timeframe: Day 0-21
The number of subjects seroprotected by HI antibodies
Timeframe: Day 0-21
The number of subjects seroconverted to HI antibodies
Timeframe: At Day 21
HI antibody seroconversion factors (SCF)
Timeframe: At Day 21
Number of subjects reporting any and related serious adverse events (SAEs) from Day 21 to Day 364
Timeframe: Day 21-364
Interventions:
Biological/vaccine: Influenza vaccine GSK2186877A
Biological/vaccine: GSK Biologicals’ Fluarix™
Enrollment:
971
Observational study model:
Not applicable
Primary completion date:
2009-15-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK2186877A, SB218352
Collaborators
Not applicable
Study date(s)
October 2008 to December 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
19+ years
Accepts healthy volunteers
Yes
- A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
- Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female subject previously enrolled in study 109821 (NCT 00529516) in the >= 65 years and 18-41 years of age groups and having received the study vaccine.
- Subjects of whom the investigator believes that they can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by medical history and clinical examination 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.
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 2008 with any seasonal influenza vaccine.
- 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.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccines.
- 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 administration of the study vaccine or planned administration during the study period.
- 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.
- Any medical conditions in which intramuscular injections are contraindicated.
- Pregnant or lactating females.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Trial location(s)
Location
GSK Investigational Site
Messkirch, Baden-Wuerttemberg, Germany, 88605
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Milford, Massachusetts, United States, 01757
Status
Study Complete
Location
GSK Investigational Site
Ruedersdorf, Brandenburg, Germany, 15562
Status
Study Complete
Location
GSK Investigational Site
Chaska, Minnesota, United States, 55318
Status
Study Complete
Location
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
Status
Study Complete
Location
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
Status
Study Complete
Location
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
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
2009-15-12
Actual study completion date
2009-15-12
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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