Clinical trial NCT00545025: Revaccination With Influenza Vaccine GSK1247446A
Official title: Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Influenza, Human
Keywords: Influenza
Influenza vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

Detailed description: The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility criteria: Inclusion Criteria:

* A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two 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 within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period
* Previous vaccination against influenza since January 2007.
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of confirmed influenza infection within the last 12 months.
* Pregnancy.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute disease at the time of enrolment.

Primary outcomes:
measure: Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
timeFrame: During a 7-day (Days 0-6) follow-up period after re-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During a 7-day (Days 0-6) follow-up after re-vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During a 30-day (Days 0-29) follow-up period after re-vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Days 0-30)
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Days 0 and 21
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
timeFrame: At Day 0 and 21
measure: Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.
timeFrame: At Day 21
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: