Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years

Influenza Clinical Trial

Official title:

A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616928
• Other study ID #: 110464
• Status: Completed
• Phase: Phase 3
• Start date: January 23, 2008
• Est. completion date: March 19, 2009

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4561
• Est. completion date: March 19, 2009
• Est. primary completion date: October 15, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A male or female 18 years of age or greater at the time of the first vaccination.

• Written informed consent obtained from the subject.

• Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.

• Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.

• Access to a consistent means of telephone contact.

• 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.

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 subjectunable/unlikely to provide accurate safety reports.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• 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 infection.

• Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other 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 vaccines within 30 days before study enrollment.

• Previous administration of any H5N1 vaccine.

• Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 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 enrollment or planned administration of any of these products during the study period.

• Any known or suspected allergy to any constituent of influenza vaccines; 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 test result prior to either vaccination.

• Lactating or nursing.

• 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
• Placebo
Two intramuscular injections at Days 0 and 21.

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec City	Quebec
Canada	GSK Investigational Site	Sarnia	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St-Romuald	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Woodstock	Ontario
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Missoula	Montana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Poughkeepsie	New York
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Angelo	Texas
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer = 1:40, or a pre-vaccination reciprocal HI titer = 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.	At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Primary	Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer = 1:40.	At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Primary	Number of Subjects With Any Solicited Local Symptoms.	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.	During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Primary	Number of Subjects With Any Solicited General Symptoms.	Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.	During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Primary	Number of Subjects With Any Unsolicited Adverse Events (AEs).	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
Primary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Day 0 through Day 182 and through Day 379.
Primary	Number of Subjects With Medically Attended Events (MAEs)		From Day 0 through Day 182 and through Day 364.
Secondary	Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (=) 1:10		At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Secondary	Number of Subjects With A/Indonesia/5/05 Antibody Titers = 1:10		At Month 6 (Day 182) post Dose 1
Secondary	Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer = 1:40, or a pre-vaccination reciprocal HI titer = 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.	At Month 6 (Day 182) after Dose 1
Secondary	Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)		At Month 6 (Day 182) after Dose 1
Secondary	Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)	Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was = 1:10.	At Month 6 (Day 182) after Dose 1
Secondary	Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.	Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 = 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.	At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Secondary	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays	Titers were expressed as Geometric Mean Titers (GMTs).	At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

External Links

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