A Phase IIIA Study of Immunogenicity and Safety of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in adults 18 years of age and older.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject
- •Male and female adults, 18 years of age and older in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
- •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 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
Exclusion Criteria
- •Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
- •Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Acute disease and/or fever at the time of enrolment.
- •Significant acute or chronic, uncontrolled medical or psychiatric illness.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
- •Insulin-dependent diabetes mellitus.
- •Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study vaccine dose.
Outcomes
Primary Outcomes
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Day 0 and Day 21
Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Day 0 and Day 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.
Time Frame: At Day 21
SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Secondary Outcomes
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Day 0 - Day 20 after vaccination).)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).(During the 21-day (Days 0-20) post-vaccination period.)