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
Completed
Completed
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:
Biological/vaccine: Influenza vaccine GSK2321138A
Biological/vaccine: FluarixTM
Biological/vaccine: Influenza vaccine GSK2604409A
Enrollment:
4659
Observational study model:
Not applicable
Primary completion date:
2011-06-06
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
Salisbury, North Carolina, United States, 28144
2.1 miles (3.4 km) away from your location
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
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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