Clinical trial NCT00968890: Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
Official title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: GSK Bio's influenza vaccine GSK2340272A
Influenza infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-08-31
Enrollment: 168
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

Detailed description: The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.

The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects 61 years of age or older at the time of the first vaccination
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Satisfactory baseline medical assessment by history and physical examination.
* Access to a consistent means of telephone contact.

Exclusion Criteria:

* Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
* Previous administration of a pandemic influenza vaccine.
* Administration of any vaccine within 30 days before first vaccination.
* Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Presence of an oral temperature \>= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
* Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
* Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome.
* Serious chronic disease as determined by medical history and physical examination.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
* Any known or suspected allergy to any constituent of influenza vaccines.
* History of chronic alcohol consumption and/or drug abuse.
* Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
* Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Primary outcomes:
measure: Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
timeFrame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
measure: Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
timeFrame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
measure: Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
timeFrame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Secondary outcomes:
measure: Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
timeFrame: Days 0, 21, 42, 182, 364
measure: Number of Seroconverted Subjects
timeFrame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
measure: Number of Seroprotected Subjects
timeFrame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
measure: Geometric Mean Fold Rise (GMFR)
timeFrame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
measure: Number of Subjects With Titers Equal to or Above Titer 1:10
timeFrame: Days 0, 21, 42, 182, 364
measure: Number of Subjects With Solicited Local and General Symptoms
timeFrame: Within 7 days (Day 0-Day 6) after each vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: From Day 0 to Day 83
measure: Number of Subjects With Adverse Events of Specific Interest
timeFrame: From Day 0 to Day 364
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 364
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Peeters M, Regner S, Vaman T, Devaster JM, Rombo L. Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials. Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9.