Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 4659
- Locations
- 1
- Primary Endpoint
- Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Time Frame: At Day 0 (D 0), and at Day 21 (D 21)
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
Time Frame: At Day 21 (D 21)
A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer \< 1:10 and a post-vaccination titer above or equal (\>=) 1:40, or a pre-vaccination HI antibody titer \>= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Secondary Outcomes
- Number of Days With Solicited Local Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)(From the beginning of the study (Day 0) to study end (Day 180))
- Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease(At Day 21 (D 21))
- Number of Seropositive Subjects Against 4 Strains of Influenza Disease(At Day 0 (D 0), and at Day 21 (D 21))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Days With Solicited General Symptoms(Within the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(From the beginning of the study (Day 0) to study end (Day 180))
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease(At Day 0 (D 0), and at Day 21 (D 21))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 21-day (Days 0-20) follow-up period after vaccination)
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)(From the beginning of the study (Day 0) to study end (Day 180))