Last updated: 11/07/2018 07:34:38
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Titers for hemagglutination inhibition (HI) antibodies against 4 strains of influenza disease
Timeframe: At Day 0 (D 0), and at Day 21 (D 21)
Number of seroconverted subjects against 4 strains of influenza disease
Timeframe: At Day 21 (D 21)
Secondary outcomes:
Number of seropositive subjects against 4 strains of influenza disease
Timeframe: At Day 0 (D 0), and at Day 21 (D 21)
Number of seroprotected subjects against 4 strains of influenza disease
Timeframe: At Day 0 (D 0), and at Day 21 (D 21)
Increase in hemagglutination inhibition antibodies against 4 strains of influenza disease
Timeframe: At Day 21 (D 21)
Number of subjects with any and grade 3 solicited local symptoms.
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccination
Number of days with solicited local symptoms
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccination
Number of subjects with any, grade 3 and related solicited general symptoms
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccination
Number of days with solicited general symptoms
Timeframe: Within the 7-day (Days 0-6) follow-up period after vaccination
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within the 21-day (Days 0-20) follow-up period after vaccination
Number of subjects with any and related adverse events with medically-attended events (MAEs)
Timeframe: From the beginning of the study (Day 0) to study end (Day 180)
Number of subjects with any and related potential immune-mediated diseases (pIMDs)
Timeframe: From the beginning of the study (Day 0) to study end (Day 180)
Number of subjects with any and related serious adverse events (SAEs)
Timeframe: From the beginning of the study (Day 0) to study end (Day 180)
Interventions:
Enrollment:
4659
Primary completion date:
2011-06-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bekkat-Berkani R et al. (2016) Evidence update: GlaxoSmithKline’s inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 15(2):201-214.
Kieninger D et al. (2013) Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >=18 years. BMC Infect Dis.13(1):343.
Medical condition
Influenza
Product
GSK2321138A, GSK2604409A, SB218352
Collaborators
Not applicable
Study date(s)
October 2010 to June 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Study Complete
Showing 1 - 6 of 40 Results
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
Study complete
Actual primary completion date
2011-06-06
Actual study completion date
2011-06-06
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.
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