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Trial record 13 of 28 for:    pandemrix

Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

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ClinicalTrials.gov Identifier: NCT01788228
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : April 7, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Hide Arm/Group Description Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21. Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Period Title: Overall Study
Started 49 1
Completed 48 1
Not Completed 1 0
Reason Not Completed
Migrated/moved from study area             1             0
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group Total
Hide Arm/Group Description Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21. Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21. Total of all reporting groups
Overall Number of Baseline Participants 49 1 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 1 participants 50 participants
42.5  (10.7) 85.0 [1]   (NA) 43.35  (12.18)
[1]
As this group has only 1 subject, SD cannot be calculated.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 1 participants 50 participants
Female
28
  57.1%
0
   0.0%
28
  56.0%
Male
21
  42.9%
1
 100.0%
22
  44.0%
1.Primary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
Time Frame During a 7-day follow-up period (Days 0-6) after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine Group
Hide Arm/Group Description:
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Overall Number of Participants Analyzed 49 1 50
Measure Type: Number
Unit of Measure: Subjects
Any Pain 45 1 46
Grade 3 Pain 4 0 4
Any Redness 6 0 6
Grade 3 Redness 0 0 0
Any Swelling 7 0 7
Grade 3 Swelling 0 0 0
2.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Hide Description Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever [oral temperature above 38.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C.
Time Frame During a 7-day follow-up period (Days 0-6) after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine Group
Hide Arm/Group Description:
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Overall Number of Participants Analyzed 49 1 50
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue 27 0 27
Grade 3 Fatigue 1 0 1
Related Fatigue 26 0 26
Any Gastrointestinal symptoms 12 0 12
Grade 3 Gastrointestinal symptoms 2 0 2
Related Gastrointestinal symptoms 8 0 8
Any Headache 20 0 20
Grade 3 Headache 2 0 2
Related Headache 17 0 17
Any Joint pain 14 0 14
Grade 3 Joint pain 1 0 1
Related Joint pain 13 0 13
Any Muscle ache 33 0 33
Grade 3 Muscle ache 1 0 1
Related Muscle ache 31 0 31
Any Shivering 10 0 10
Grade 3 Shivering 1 0 1
Related Shivering 8 0 8
Any Sweating 7 0 7
Grade 3 Sweating 1 0 1
Related Sweating 5 0 5
Any Fever (≥38°C) 1 0 1
Grade 3 Fever (≥39°C) 0 0 0
Related Fever 0 0 0
3.Primary Outcome
Title Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)
Hide Description Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine Group
Hide Arm/Group Description:
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Overall Number of Participants Analyzed 49 1 50
Measure Type: Number
Unit of Measure: Subjects
10 0 10
4.Secondary Outcome
Title Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.
Time Frame During the entire study period (Day 0 to Day 385)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Hide Arm/Group Description:
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Overall Number of Participants Analyzed 49 1
Measure Type: Number
Unit of Measure: Subjects
Any pIMDs 0 0
Related pIMDs 0 0
5.Secondary Outcome
Title Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Hide Description A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame During the entire study period (Day 0 to Day 385)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Hide Arm/Group Description:
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
Overall Number of Participants Analyzed 49 1
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 0 0
Related SAEs 0 0
6.Secondary Outcome
Title Assessment of the Quality of Life Measures Overall and by Age Category (18-40; 41-64; 18-64; and >64 Years of Age) Via SF-36v2® Health Assessment Questionnaires
Hide Description [Not Specified]
Time Frame Day 0 and Day 7, Day 21 and Day 28 for weekly SF-36v2 questionnaires and Day 0 to Day 7 for daily SF-36v2 questionnaires
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Assessment of Psychometric Validity and Internal Consistency of the Daily SF-36v2 Questionnaire
Hide Description [Not Specified]
Time Frame Day 0 to Day 7 for daily SF-36v2 questionnaires
Outcome Measure Data Not Reported
Time Frame Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20 post dose 1 and Day 21-41 post dose 2) post-vaccination period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group
Hide Arm/Group Description Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21. Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
All-Cause Mortality
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   45/49 (91.84%)   1/1 (100.00%) 
General disorders     
Pain   45/49 (91.84%)  1/1 (100.00%) 
Redness   6/49 (12.24%)  0/1 (0.00%) 
Swelling   7/49 (14.29%)  0/1 (0.00%) 
Fatigue   27/49 (55.10%)  0/1 (0.00%) 
Gastrointestinal symptoms   12/49 (24.49%)  0/1 (0.00%) 
Headache   20/49 (40.82%)  0/1 (0.00%) 
Joint pain   14/49 (28.57%)  0/1 (0.00%) 
Muscle ache   33/49 (67.35%)  0/1 (0.00%) 
Shivering   10/49 (20.41%)  0/1 (0.00%) 
Sweating   7/49 (14.29%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01788228     History of Changes
Other Study ID Numbers: 116861
First Submitted: January 31, 2013
First Posted: February 11, 2013
Results First Submitted: March 26, 2015
Results First Posted: April 7, 2015
Last Update Posted: May 12, 2016