Clinical trial NCT00633074: Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
Official title: Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 720
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female 65 years of age or older at the time of vaccination.
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

* Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
* Previous vaccination against influenza with any seasonal vaccine since July 2007.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Any medical conditions in which IM injections are contraindicated

Primary outcomes:
measure: Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
timeFrame: Days 0 and 21
Secondary outcomes:
measure: Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
timeFrame: Days 0 and 21
measure: Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
timeFrame: Day 21
measure: HI Antibody Seroconversion Factors
timeFrame: Day 21
measure: Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
timeFrame: Days 0 and 21
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During a 7-day period after vaccination
measure: Duration of Solicited Local Symptoms
timeFrame: During a 7-day period after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During a 7-day period after vaccination
measure: Duration of Solicited General Symptoms
timeFrame: During a 7-day period after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During a 21-day period after vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
timeFrame: During a 21-day period after vaccination
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (up to Day 21)
Other outcomes:
Locations:
city: Saku
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: