Clinical trial NCT00951041: Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Official title: Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 to 60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: influenza infection
GSK Bio's influenza vaccine GSK2340272A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 130
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 the study is to evaluate the safety and immunogenicity of GSK Biologicals' influenza vaccine GSK2340272A.


Eligibility criteria: Inclusion Criteria:

* A male or female aged 18 to 60 years 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. Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
* Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
* Female subjects of non-childbearing potential may be enrolled in the study.

  * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
* 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 axillary temperature ≥ 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
* Diagnosed with cancer, or treatment for cancer, within the past 3 years.

  * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
  * Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are excepted and may enroll within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above.
  * Women who are disease free 3 years or more after the treatment for breast cancer and receiving long-term prophylactic are excepted and may enroll.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
* Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
* Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the 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 antiplatelet 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.
* Administration of any vaccines within 30 days before vaccination.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* Pregnant or lactating female
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 35
measure: Number of Seroconverted Subjects for HI Antibodies
timeFrame: At Day 35
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Day 35
measure: Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 35
Secondary outcomes:
measure: Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Days 0 and 21
measure: Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 182
measure: Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 364
measure: Number of Seroconverted Subjects for HI Antibodies
timeFrame: At Day 21
measure: Number of Seroconverted Subjects for HI Antibodies
timeFrame: At Day 182
measure: Number of Seroconverted Subjects for HI Antibodies
timeFrame: At Day 364
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Days 0 and 21
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Day 182
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Day 364
measure: Seroconversion Factor (SCF) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 21
measure: SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 35
measure: SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 182
measure: SCF for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 364
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) follow-up period after each dose and across doses
measure: Number of Days With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) follow-up period after each dose and overall
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) follow-up period after each dose and across doses
measure: Number of Days With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) follow-up period after each dose and overall
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day (Days 0-20) follow-up after the first vaccination and during the 63-day (Days 21-83) follow-up after the second vaccination (From Day 0 to Day 84)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (From Day 0 up to Day 364)
measure: Number of Subjects With Adverse Events of Specific Interest (AESI)
timeFrame: During the entire study period (From Day 0 up to Day 364)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: