Clinical trial NCT00714285: Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Official title: Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Primary study
immunogenicity
safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-14
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
timeFrame: At Day 0 and Day 21
Secondary outcomes:
measure: Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
timeFrame: At Day 21
measure: HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
timeFrame: Day 21
measure: Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
timeFrame: At Days 0 and 21
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: During a 7 day (Days 0-6) follow-up period after vaccination
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
timeFrame: During a 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During a 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
timeFrame: During a 7-day follow-up period (Days 0-6) after vaccination
measure: Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
timeFrame: During the entire study period (Days 0-180)
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
timeFrame: During a 21 day (Days 0-20) follow-up period after vaccination-
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Days 0-180)
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Beran J, Peeters M, Dewe W, Raupachova J, Hobzova L, Devaster JM. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013 May 20;13:224. doi: 10.1186/1471-2334-13-224.