Clinical trial NCT00812981: A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.
Official title: Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Pandemic influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic 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 aged 18 to 60 years at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Good general health as established by medical history and clinical examination before entering into the study.
* 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 other multiple-user device
* Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
* If the subject is female, she must be of non-childbearing potential, or 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:

* Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* An oral temperature ≥ 37.8 º C or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
* Receipt of systemic glucocorticoids (prednisone ≥ 5 mg/kg/day for more than 14 consecutive days) within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.
* Any significant disorder of coagulation or treatment with Coumarin derivatives or Heparin.
* Administration of any vaccines within 30 days before study enrolment.
* Previous administration of any H5N1 vaccine.
* Previous administration of vaccines with adjuvants similar to those used in the investigational vaccine.
* Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrolment, or during the 180 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
* 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 known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to either vaccination.
* Lactating women.
* Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
* Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.

Primary outcomes:
measure: Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
timeFrame: At Day 42
Secondary outcomes:
measure: Titers for Serum H5N1 HI Antibodies
timeFrame: At Day 0 and Day 180
measure: Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value
timeFrame: At Days 0, 42 and 180
measure: Number of Seroconverted Subjects Against Two Strains of Influenza Disease
timeFrame: At Day 42 and Day 180
measure: Seroconversion Factor (SCF) for H5N1 HI Antibodies
timeFrame: At Day 42 and Day 180
measure: Number of Seroprotected Subjects for H5N1 HI Antibodies
timeFrame: At Days 0, 42 and 180
measure: Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease
timeFrame: At Days 0, 42 and 180
measure: Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
timeFrame: At Days 0, 42 and 180
measure: Number of Seroconverted Subjects for Neutralizing Antibodies
timeFrame: At Day 42 and Day 180
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
measure: Number of Subjects With Any Adverse Events of Specific Interest (AESIs)
timeFrame: From Day 0 up to 51 days after the first vaccination
measure: Number of Subjects With Any AESIs
timeFrame: During the entire study period (from Day 0 up to Day 180)
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the entire study period (from Day 0 up to Day 180)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to Day 51
measure: Number of Subjects With SAEs
timeFrame: During the entire study period (from Day 0 up to Day 180)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yang PC, Yu CJ, Chang SC, Hsieh SM, Drame M, Walravens K, Roman F, Gillard P. Safety and immunogenicity of a split-virion AS03A-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine in Taiwanese adults. J Formos Med Assoc. 2012 Jun;111(6):333-9. doi: 10.1016/j.jfma.2011.02.006. Epub 2012 Apr 20.