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Trial record 27 of 28 for:    pandemrix AND influenza vaccine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00616928
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : February 7, 2014
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
Study Start Date : January 23, 2008
Actual Primary Completion Date : October 15, 2008
Actual Study Completion Date : March 19, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 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.
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.

Placebo Comparator: 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.
Biological: Placebo
Two intramuscular injections at Days 0 and 21.

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

Placebo Comparator: 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.
Biological: Placebo
Two intramuscular injections at Days 0 and 21.

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

Placebo Comparator: 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.
Biological: Placebo
Two intramuscular injections at Days 0 and 21.

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

Placebo Comparator: 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.
Biological: Placebo
Two intramuscular injections at Days 0 and 21.

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

Placebo Comparator: 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.
Biological: Placebo
Two intramuscular injections at Days 0 and 21.




Primary Outcome Measures :
  1. Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) [ Time Frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2) ]
    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.

  2. Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) [ Time Frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2) ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

  3. Number of Subjects With Any Solicited Local Symptoms. [ Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  4. Number of Subjects With Any Solicited General Symptoms. [ Time Frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration ]
    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.

  5. Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84) ]
    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.

  6. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 through Day 182 and through Day 379. ]
    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.

  7. Number of Subjects With Medically Attended Events (MAEs) [ Time Frame: From Day 0 through Day 182 and through Day 364. ]

Secondary Outcome Measures :
  1. Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10 [ Time Frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2) ]
  2. Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10 [ Time Frame: At Month 6 (Day 182) post Dose 1 ]
  3. Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) [ Time Frame: At Month 6 (Day 182) after Dose 1 ]
    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.

  4. Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) [ Time Frame: At Month 6 (Day 182) after Dose 1 ]
  5. Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1) [ Time Frame: At Month 6 (Day 182) after Dose 1 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.

  6. Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays. [ Time Frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2) ]
    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.

  7. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays [ Time Frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2) ]
    Titers were expressed as Geometric Mean Titers (GMTs).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616928


Locations
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United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85020
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Melbourne, Florida, United States, 32935
GSK Investigational Site
Miami, Florida, United States, 33143
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60610
GSK Investigational Site
Peoria, Illinois, United States, 61602
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20850
United States, Missouri
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59801
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08817
United States, New York
GSK Investigational Site
Poughkeepsie, New York, United States, 12601
GSK Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16506
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, South Carolina
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Fort Worth, Texas, United States, 76135
GSK Investigational Site
San Angelo, Texas, United States, 76904
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
London, Ontario, Canada, N5W 6A2
GSK Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 6C3
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 4G3
Canada, Quebec
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Quebec City, Quebec, Canada, G1E 7G9
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
GSK Investigational Site
St-Romuald, Quebec, Canada, G6W 5M6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110464
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00616928    
Other Study ID Numbers: 110464
First Posted: February 15, 2008    Key Record Dates
Results First Posted: February 7, 2014
Last Update Posted: June 8, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
vaccines
immunogenicity
human
safety
influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases