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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults

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ClinicalTrials.gov Identifier: NCT01416571
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : April 16, 2014
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Enrollment 78
Recruitment Details This study was conducted in two phases: the Primary Vaccination Phase (up to Day 84) and the Immunogenicity and Safety follow-up Phase (up to Day 385).
Pre-assignment Details  
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Period Title: Overall Study
Started 78
Completed 76 [1]
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
[1]
Number of subjects completed at Day 385.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
40.6  (13.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
41
  52.6%
Male
37
  47.4%
1.Primary Outcome
Title Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Measure Type: Count of Participants
Unit of Measure: Participants
72
  96.0%
2.Primary Outcome
Title Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
Hide Description MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
41.7
(32.0 to 54.3)
3.Primary Outcome
Title Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
Hide Description A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Measure Type: Count of Participants
Unit of Measure: Participants
74
  98.7%
4.Secondary Outcome
Title Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
Hide Description A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Measure Type: Count of Participants
Unit of Measure: Participants
H5N1 at Day 0
26
  34.7%
H5N1 at Day 42
75
 100.0%
5.Secondary Outcome
Title Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs).
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0
7.5
(6.5 to 8.6)
H5N1 at Day 42
311.3
(249.2 to 389.0)
6.Secondary Outcome
Title Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
Hide Description A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Time Frame At Day 0 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
H5N1 at Day 0 Number Analyzed 74 participants
27
  36.5%
H5N1 at Day 182 Number Analyzed 73 participants
73
 100.0%
7.Secondary Outcome
Title Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs).
Time Frame At Day 0 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0 Number Analyzed 74 participants
7.8
(6.6 to 9.1)
H5N1 at Day 182 Number Analyzed 73 participants
56.3
(47.0 to 67.5)
8.Secondary Outcome
Title Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
Hide Description A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Time Frame At Day 0 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
H5N1 at Day 0 Number Analyzed 74 participants
3
   4.1%
H5N1 at Day 182 Number Analyzed 73 participants
56
  76.7%
9.Secondary Outcome
Title Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Time Frame At Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 73
Measure Type: Count of Participants
Unit of Measure: Participants
48
  65.8%
10.Secondary Outcome
Title Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
Hide Description MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Time Frame At Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 73
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
7.2
(5.8 to 9.0)
11.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).
Time Frame During the 7-day follow-up period (Days 0-6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
71
  91.0%
Any Redness
7
   9.0%
Any Swelling
12
  15.4%
Grade 3 Pain
6
   7.7%
Grade 3 Redness
0
   0.0%
Grade 3 Swelling
0
   0.0%
12.Secondary Outcome
Title Duration of Solicited Local Symptoms After Vaccination.
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 70
Median (Inter-Quartile Range)
Unit of Measure: days
Pain, Dose 1 Number Analyzed 70 participants
3.0
(2.0 to 4.0)
Pain, Dose 2 Number Analyzed 60 participants
3.0
(2.0 to 3.0)
Redness, Dose1 Number Analyzed 5 participants
2.0
(1.0 to 2.0)
Redness, Dose 2 Number Analyzed 3 participants
3.0
(1.0 to 4.0)
Swelling, Dose 1 Number Analyzed 10 participants
2.0
(1.0 to 3.0)
Swelling, Dose 2 Number Analyzed 5 participants
1.0
(1.0 to 2.0)
13.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time Frame During the 7-day follow-up period (Days 0-6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
35
  44.9%
Grade 3 Fatigue
3
   3.8%
Related Fatigue
26
  33.3%
Any Gastrointestinal
13
  16.7%
Grade 3 Gastrointestinal
0
   0.0%
Related Gastrointestinal
6
   7.7%
Any Headache
28
  35.9%
Grade 3 Headache
1
   1.3%
Related Headache
20
  25.6%
Any Joint Pain
13
  16.7%
Grade 3 Joint Pain
0
   0.0%
Related Joint Pain
13
  16.7%
Any Muscle Aches
31
  39.7%
Grade 3 Muscle Aches
3
   3.8%
Related Muscle Aches
27
  34.6%
Any Shivering
10
  12.8%
Grade 3 Shivering
1
   1.3%
Related Shivering
10
  12.8%
Any Sweating
11
  14.1%
Grade 3 Sweating
0
   0.0%
Related Sweating
8
  10.3%
Any Fever
0
   0.0%
Grade 3 Fever
0
   0.0%
Related Fever
0
   0.0%
14.Secondary Outcome
Title Duration of Solicited General Symptoms After Vaccination.
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 26
Median (Inter-Quartile Range)
Unit of Measure: days
Fatigue, Dose 1 Number Analyzed 23 participants
2.0
(1.0 to 3.0)
Fatigue, Dose 2 Number Analyzed 26 participants
2.0
(1.0 to 3.0)
Gastrointestinal, Dose 1 Number Analyzed 11 participants
2.0
(1.0 to 3.0)
Gastrointestinal, Dose 2 Number Analyzed 7 participants
2.0
(2.0 to 3.0)
Headache, Dose 1 Number Analyzed 20 participants
1.5
(1.0 to 2.0)
Headache, Dose 2 Number Analyzed 18 participants
1.5
(1.0 to 2.0)
Joint Pain, Dose 1 Number Analyzed 6 participants
1.5
(1.0 to 3.0)
Joint Pain, Dose 2 Number Analyzed 12 participants
2.0
(1.5 to 3.0)
Muscle aches, Dose 1 Number Analyzed 18 participants
2.0
(1.0 to 3.0)
Muscle aches, Dose 2 Number Analyzed 24 participants
2.0
(1.0 to 2.5)
Increased sweating, Dose 1 Number Analyzed 7 participants
2.0
(1.0 to 3.0)
Increased sweating, Dose 2 Number Analyzed 6 participants
2.5
(1.0 to 3.0)
Shivering, Dose 1 Number Analyzed 2 participants
2.0
(1.0 to 3.0)
Shivering, Dose 2 Number Analyzed 9 participants
1.0
(1.0 to 1.0)
15.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Hide Description MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.
Time Frame From Day 0 to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any MAEs
20
  25.6%
Grade 3 MAEs
6
   7.7%
Related MAEs
0
   0.0%
16.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Hide Description MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time Frame From Day 0 to Day 385
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any MAEs
49
  62.8%
Grade 3 MAEs
9
  11.5%
Related MAEs
0
   0.0%
17.Secondary Outcome
Title Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
Hide Description pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.
Time Frame From Day 0 to Day 84 and from Day 0 to Day 385
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
pIMD(s), Day 0 to Day 84
0
   0.0%
pIMD(s), Day 0 to Day 385
0
   0.0%
18.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Hide Description Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
BAS, unknown, Day 0 Number Analyzed 78 participants
1
   1.3%
BAS, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
BAS, below, Day 0 Number Analyzed 78 participants
0
   0.0%
BAS, below, Day 42 Number Analyzed 77 participants
0
   0.0%
BAS, within, Day 0 Number Analyzed 78 participants
77
  98.7%
BAS, within, Day 42 Number Analyzed 77 participants
76
  98.7%
BAS, above, Day 0 Number Analyzed 78 participants
0
   0.0%
BAS, above, Day 42 Number Analyzed 77 participants
0
   0.0%
EOS, unknown, Day 0 Number Analyzed 78 participants
1
   1.3%
EOS, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
EOS, below, Day 0 Number Analyzed 78 participants
23
  29.5%
EOS, below, Day 42 Number Analyzed 77 participants
12
  15.6%
EOS, within, Day 0 Number Analyzed 78 participants
53
  67.9%
EOS, within, Day 42 Number Analyzed 77 participants
64
  83.1%
EOS, above, Day 0 Number Analyzed 78 participants
1
   1.3%
EOS, above, Day 42 Number Analyzed 77 participants
0
   0.0%
HCRIT, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
HCRIT, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
HCRIT, below, Day 0 Number Analyzed 78 participants
2
   2.6%
HCRIT, below, Day 42 Number Analyzed 77 participants
5
   6.5%
HCRIT, within, Day 0 Number Analyzed 78 participants
68
  87.2%
HCRIT, within, Day 42 Number Analyzed 77 participants
66
  85.7%
HCRIT, above, Day 0 Number Analyzed 78 participants
8
  10.3%
HCRIT, above, Day 42 Number Analyzed 77 participants
5
   6.5%
19.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Hide Description Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
HBIN, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
HBIN, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
HBIN, below, Day 0 Number Analyzed 78 participants
7
   9.0%
HBIN, below, Day 42 Number Analyzed 77 participants
6
   7.8%
HBIN, within, Day 0 Number Analyzed 78 participants
68
  87.2%
HBIN, within, Day 42 Number Analyzed 77 participants
68
  88.3%
HBIN, above, Day 0 Number Analyzed 78 participants
3
   3.8%
HBIN, above, Day 42 Number Analyzed 77 participants
2
   2.6%
LYM, unknown, Day 0 Number Analyzed 78 participants
1
   1.3%
LYM, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
LYM, below, Day 0 Number Analyzed 78 participants
2
   2.6%
LYM, below, Day 42 Number Analyzed 77 participants
0
   0.0%
LYM, within, Day 0 Number Analyzed 78 participants
75
  96.2%
LYM, within, Day 42 Number Analyzed 77 participants
76
  98.7%
LYM, above, Day 0 Number Analyzed 78 participants
0
   0.0%
LYM, above, Day 42 Number Analyzed 77 participants
0
   0.0%
MON, unknown, Day 0 Number Analyzed 78 participants
1
   1.3%
MON, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
MON, below, Day 0 Number Analyzed 78 participants
46
  59.0%
MON, below, Day 42 Number Analyzed 77 participants
9
  11.7%
MON, within, Day 0 Number Analyzed 78 participants
31
  39.7%
MON, within, Day 42 Number Analyzed 77 participants
67
  87.0%
MON, above, Day 0 Number Analyzed 78 participants
0
   0.0%
MON, above, Day 42 Number Analyzed 77 participants
0
   0.0%
20.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Hide Description Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
NEU, unknown, Day 0 Number Analyzed 78 participants
1
   1.3%
NEU, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
NEU, below, Day 0 Number Analyzed 78 participants
2
   2.6%
NEU, below, Day 42 Number Analyzed 77 participants
1
   1.3%
NEU, within, Day 0 Number Analyzed 78 participants
71
  91.0%
NEU, within, Day 42 Number Analyzed 77 participants
75
  97.4%
NEU, above, Day 0 Number Analyzed 78 participants
4
   5.1%
NEU, above, Day 42 Number Analyzed 77 participants
0
   0.0%
PLA, unknown, Day 0 Number Analyzed 78 participants
3
   3.8%
PLA, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
PLA, below, Day 0 Number Analyzed 78 participants
0
   0.0%
PLA, below, Day 42 Number Analyzed 77 participants
1
   1.3%
PLA, within, Day 0 Number Analyzed 78 participants
74
  94.9%
PLA, within, Day 42 Number Analyzed 77 participants
74
  96.1%
PLA, above, Day 0 Number Analyzed 78 participants
1
   1.3%
PLA, above, Day 42 Number Analyzed 77 participants
0
   0.0%
RBC, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
RBC, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
RBC, below, Day 0 Number Analyzed 78 participants
5
   6.4%
RBC, below, Day 42 Number Analyzed 77 participants
3
   3.9%
RBC, within, Day 0 Number Analyzed 78 participants
72
  92.3%
RBC, within, Day 42 Number Analyzed 77 participants
72
  93.5%
RBC, above, Day 0 Number Analyzed 78 participants
1
   1.3%
RBC, above, Day 42 Number Analyzed 77 participants
1
   1.3%
21.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Hide Description Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
WBC, unknown, Day 0 Number Analyzed 78 participants
1
   1.3%
WBC, unknown, Day 42 Number Analyzed 77 participants
1
   1.3%
WBC, below, Day 0 Number Analyzed 78 participants
2
   2.6%
WBC, below, Day 42 Number Analyzed 77 participants
2
   2.6%
WBC, within, Day 0 Number Analyzed 78 participants
72
  92.3%
WBC, within, Day 42 Number Analyzed 77 participants
74
  96.1%
WBC, above, Day 0 Number Analyzed 78 participants
3
   3.8%
WBC, above, Day 42 Number Analyzed 77 participants
0
   0.0%
ALT, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
ALT, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
ALT, below, Day 0 Number Analyzed 78 participants
0
   0.0%
ALT, below, Day 42 Number Analyzed 77 participants
0
   0.0%
ALT, within, Day 0 Number Analyzed 78 participants
76
  97.4%
ALT, within, Day 42 Number Analyzed 77 participants
73
  94.8%
ALT, above, Day 0 Number Analyzed 78 participants
2
   2.6%
ALT, above, Day 42 Number Analyzed 77 participants
2
   2.6%
AST, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
AST, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
AST, below, Day 0 Number Analyzed 78 participants
0
   0.0%
AST, below, Day 42 Number Analyzed 77 participants
0
   0.0%
AST, within, Day 0 Number Analyzed 78 participants
78
 100.0%
AST, within, Day 42 Number Analyzed 77 participants
74
  96.1%
AST, above, Day 0 Number Analyzed 78 participants
0
   0.0%
AST, above, Day 42 Number Analyzed 77 participants
1
   1.3%
22.Secondary Outcome
Title Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Hide Description Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Total BIL, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
Total BIL, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
Total BIL, below, Day 0 Number Analyzed 78 participants
0
   0.0%
Total BIL, below, Day 42 Number Analyzed 77 participants
0
   0.0%
Total BIL, within, Day 0 Number Analyzed 78 participants
76
  97.4%
Total BIL, within, Day 42 Number Analyzed 77 participants
74
  96.1%
Total BIL, above, Day 0 Number Analyzed 78 participants
2
   2.6%
Total BIL, above, Day 42 Number Analyzed 77 participants
1
   1.3%
BIL con/dir, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
BIL con/dir, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
BIL con/dir, below, Day 0 Number Analyzed 78 participants
0
   0.0%
BIL con/dir, below, Day 42 Number Analyzed 77 participants
0
   0.0%
BIL con/dir, within, Day 0 Number Analyzed 78 participants
78
 100.0%
BIL con/dir, within, Day 42 Number Analyzed 77 participants
75
  97.4%
BIL con/dir, above, Day 0 Number Analyzed 78 participants
0
   0.0%
BIL con/dir, above, Day 42 Number Analyzed 77 participants
0
   0.0%
CREA, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
CREA, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
CREA, below, Day 0 Number Analyzed 78 participants
5
   6.4%
CREA, below, Day 42 Number Analyzed 77 participants
5
   6.5%
CREA, within, Day 0 Number Analyzed 78 participants
73
  93.6%
CREA, within, Day 42 Number Analyzed 77 participants
68
  88.3%
CREA, above, Day 0 Number Analyzed 78 participants
0
   0.0%
CREA, above, Day 42 Number Analyzed 77 participants
2
   2.6%
BUN, unknown, Day 0 Number Analyzed 78 participants
0
   0.0%
BUN, unknown, Day 42 Number Analyzed 77 participants
2
   2.6%
BUN, below, Day 0 Number Analyzed 78 participants
1
   1.3%
BUN, below, Day 42 Number Analyzed 77 participants
0
   0.0%
BUN, within, Day 0 Number Analyzed 78 participants
76
  97.4%
BUN, within, Day 42 Number Analyzed 77 participants
74
  96.1%
BUN, above, Day 0 Number Analyzed 78 participants
1
   1.3%
BUN, above, Day 42 Number Analyzed 77 participants
1
   1.3%
23.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time Frame From Day 0 to Day 20 and from Day 0 to Day 84.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AEs [Days 0-20]
38
  48.7%
Grade 3 unsolicited AEs [Days 0-20]
5
   6.4%
Related unsolicited AEs [Days 0-20]
7
   9.0%
Any unsolicited AEs [Days 0-84]
46
  59.0%
Grade 3 unsolicited AEs [Days 0-84]
7
   9.0%
Related unsolicited AEs [Days 0-84]
7
   9.0%
24.Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in 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 From Day 0 to Day 84 and from Day 0 to Day 385
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs [Days 0-84]
2
   2.6%
Any SAEs [Days 0-385]
3
   3.8%
Related SAEs [Days 0-84]
0
   0.0%
Related SAEs [Days 0-385]
0
   0.0%
Time Frame Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influenza A (H5N1) Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
All-Cause Mortality
Influenza A (H5N1) Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) Group
Affected / at Risk (%)
Total   3/78 (3.85%) 
General disorders   
Hernia obstructive * 1  1/78 (1.28%) 
Infections and infestations   
Pneumonia * 1  1/78 (1.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Small cell lung cancer * 1  1/78 (1.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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) Group
Affected / at Risk (%)
Total   74/78 (94.87%) 
General disorders   
Pain  1  71/78 (91.03%) 
Redness  1  7/78 (8.97%) 
Swelling  1  12/78 (15.38%) 
Fatigue  1  35/78 (44.87%) 
Gastrointestinal  1  13/78 (16.67%) 
Headache  1  28/78 (35.90%) 
Joint pain  1  13/78 (16.67%) 
Muscle aches  1  31/78 (39.74%) 
Shivering  1  10/78 (12.82%) 
Sweating  1  11/78 (14.10%) 
Infections and infestations   
Nasopharyngitis * 1  10/78 (12.82%) 
Musculoskeletal and connective tissue disorders   
Neck pain * 1  4/78 (5.13%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  5/78 (6.41%) 
Oropharyngeal pain * 1  4/78 (5.13%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: NCT01416571     History of Changes
Other Study ID Numbers: 112691
First Submitted: August 12, 2011
First Posted: August 15, 2011
Results First Submitted: December 19, 2013
Results First Posted: April 16, 2014
Last Update Posted: September 21, 2018