Clinical trial NCT00510874: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
Official title: A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
GSK 1557484A vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: The study has five core arms and the stratification is based on site and age. In addition, there are 4 possible contingent groups of which 2 will be studied based on an analysis concerning immunogenicity performance at Day 42 in core groups above.

Eligibility criteria: Inclusion Criteria:

* Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
* Good general health as assessed by medical history and physical examination.
* Access to a consistent means of telephone contact
* Written informed consent obtained from the subject.
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria:

* Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
* 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.
* Blood pressure abnormalities
* Diagnosed with cancer, or treatment for cancer, within 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 histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
* Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
* Presence of an oral temperature ≥ 37.8º 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 cytotoxic or immunosuppressive drug within 6 months of study enrollment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Administration of any non-influenza vaccines within 30 days before study enrollment or during the study period.
* Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the study period.
* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to dosing on Study Days 0 or 21.
* Lactating or nursing.
* Women of child bearing potential who lack a history of reliable contraceptive practices.
* Known receipt of analgesic or antipyretic medication on the day of treatment

Primary outcomes:
measure: Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Day 42
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Day 42
measure: Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Day 42
measure: Number of Subjects With Solicited Local Symptoms.
timeFrame: Within the 7-day follow-up period (Days 0-6) after any vaccination
measure: Number of Subjects With Solicited General Symptoms.
timeFrame: Within the 7-day follow-up period (Days 0-6) after any vaccination
measure: Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
timeFrame: From Day 0 to 182
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: During the 21-day follow-up period (Days 0-20) after vaccination.
measure: Number of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: Between Day 0 and Day 84 after vaccination.
measure: Number of Subjects With Any Serious Adverse Events (SAEs).
timeFrame: From Day 0 to 182
Secondary outcomes:
measure: Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Day 21 and Day 182
measure: Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Days 21 and 182
measure: Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Days 21 and 182
measure: Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
timeFrame: At Days 0, 21 and 182
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis. 2010 Jun 1;201(11):1644-53. doi: 10.1086/652701.