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

NCT ID: NCT00616928

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4561 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-23
• Study Completion Date: 2009-03-19

Brief 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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Influenza A (H5N1) 18-64Y Group

Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Placebo 18-64Y Group

Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Influenza A (H5N1) >64Y Group

Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Placebo >64Y Group

Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Influenza A (H5N1) Group

Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Placebo Group

Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Influenza A (H5N1) 18-60Y Group

Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Placebo 18-60Y Group

Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Influenza A (H5N1) >60Y Group

Subjects aged \>60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Placebo >60Y Group

Subjects aged \> 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two intramuscular injections at Days 0 and 21.

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Two intramuscular injections at Days 0 and 21.

Intervention Type: BIOLOGICAL

Placebo

Two intramuscular injections at Days 0 and 21.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Melbourne, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Peoria, Illinois, United States

GSK Investigational Site

South Bend, Indiana, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Rockville, Maryland, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Missoula, Montana, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Edison, New Jersey, United States

GSK Investigational Site

Poughkeepsie, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

San Angelo, Texas, United States

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Sarnia, Ontario, Canada

GSK Investigational Site

Woodstock, Ontario, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Saint Romuald, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis. 2011 Jun 15;203(12):1729-38. doi: 10.1093/infdis/jir172.

Reference Type: DERIVED

PMID: 21606531 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

110464

Identifier Type: -

Identifier Source: org_study_id