Phase 1
N=420
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00714285 ↗Enrolled (actual)
420
Serious AEs
0.2%
Results posted
Sep 2013
Primary outcome: Primary: Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. — 21.4; 22.2; 23.3; 18.4 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- GSK Biologicals' quadrivalent influenza vaccine (Biological); GSK Biologicals' trivalent influenza vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. |
21.4; 22.2; 23.3; 18.4; 130.0; 150.6 | — |
| SECONDARY Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. |
59; 60; 57; 63; 63; 69 | — |
| SECONDARY HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains |
6.1; 6.8; 6.9; 7.3; 5.5; 7.4 | — |
| SECONDARY Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. |
39; 44; 42; 37; 96; 92 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. |
76; 79; 74; 52; 0; 2 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. |
76; 79; 74; 52; 0; 2 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. |
6; 25; 13; 12; 1; 3 | — |
| SECONDARY Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. |
6; 25; 13; 12; 1; 3 | — |
| SECONDARY Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). |
1; 4; 5; 5; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). |
7; 7; 16; 11; 0; 1 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
0; 0; 0; 1.0; 0; 0 | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, 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
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease 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.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- 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.
- History of administration of experimental/licensed vaccine.
Data sourced from ClinicalTrials.gov (NCT00714285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.