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Trial record 27 of 28 for:    pandemrix

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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Biological: Placebo
Enrollment 4561

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 2304 768 1118 371
Completed 2242 750 1101 364
Not Completed 62 18 17 7
Reason Not Completed
Adverse Event             6             3             2             2
Other             51             8             15             5
Lost to Follow-up             5             7             0             0
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group Total
Hide Arm/Group Description Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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. 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. Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 2304 768 1118 371 4561
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2304 participants 768 participants 1118 participants 371 participants 4561 participants
38.5  (13.64) 38.7  (13.58) 71.9  (5.49) 72.1  (5.41) 49.5  (19.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2304 participants 768 participants 1118 participants 371 participants 4561 participants
Female
1328
  57.6%
424
  55.2%
621
  55.5%
196
  52.8%
2569
  56.3%
Male
976
  42.4%
344
  44.8%
497
  44.5%
175
  47.2%
1992
  43.7%
1.Primary Outcome
Title Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Hide Description 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.
Time Frame At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 1571 76 396 40
Measure Type: Number
Unit of Measure: Subjects
1427 1 293 1
2.Primary Outcome
Title Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Hide Description A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Time Frame At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 1571 76 396 40
Measure Type: Number
Unit of Measure: Subjects
Day 0 5 0 9 0
Day 42 1467 1 334 1
3.Primary Outcome
Title Number of Subjects With Any Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group Influenza A (H5N1) Group Placebo Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 2267 754 1109 368 3376 1122
Measure Type: Number
Unit of Measure: Subjects
Pain 2024 171 784 53 2808 224
Redness 181 7 106 1 287 8
Swelling 241 7 110 1 351 8
4.Primary Outcome
Title Number of Subjects With Any Solicited General Symptoms.
Hide Description 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.
Time Frame During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group Influenza A (H5N1) Group Placebo Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 2266 755 1109 368 3375 1123
Measure Type: Number
Unit of Measure: Subjects
Fatigue 890 189 258 64 1148 253
Headache 932 249 247 63 1179 312
Joint pain at other location 645 97 208 39 853 136
Muscle aches 1188 175 338 56 1526 231
Shivering 456 87 107 22 563 109
Sweating 314 67 48 15 362 109
Temperature 121 32 35 6 156 109
5.Primary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs).
Hide Description 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.
Time Frame During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 2304 768 1118 371
Measure Type: Number
Unit of Measure: Subjects
Unsolicited AEs Days 0-21 914 289 399 113
Unsolicited AEs Days 0-84 1017 321 467 130
6.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Day 0 through Day 182 and through Day 379.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 2304 768 1118 371
Measure Type: Number
Unit of Measure: Subjects
Subjects with SAEs Days 0-182 24 7 43 14
Subjects with SAEs Days 0-379 46 15 65 30
7.Primary Outcome
Title Number of Subjects With Medically Attended Events (MAEs)
Hide Description [Not Specified]
Time Frame From Day 0 through Day 182 and through Day 364.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 2304 768 1118 371
Measure Type: Number
Unit of Measure: Subjects
Subjects with MAEs Days 0-182 480 154 298 92
Subjects with MAEs Days 0-379 627 212 400 134
8.Secondary Outcome
Title Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Hide Description [Not Specified]
Time Frame At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.
Arm/Group Title Influenza A (H5N1) 18-60Y Group Placebo 18-60Y Group Influenza A (H5N1) >60Y Group Placebo >60Y Group
Hide Arm/Group Description:
Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 1488 68 479 48
Measure Type: Number
Unit of Measure: Subjects
1391 1 410 1
9.Secondary Outcome
Title Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Hide Description [Not Specified]
Time Frame At Month 6 (Day 182) post Dose 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo ˃ 64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 366 37 91 19
Measure Type: Number
Unit of Measure: Subjects
258 2 77 1
10.Secondary Outcome
Title Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Hide Description 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.
Time Frame At Month 6 (Day 182) after Dose 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 366 37 91 19
Measure Type: Number
Unit of Measure: Subjects
225 1 59 0
11.Secondary Outcome
Title Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Hide Description [Not Specified]
Time Frame At Month 6 (Day 182) after Dose 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 366 37 91 19
Measure Type: Number
Unit of Measure: Subjects
225 1 60 0
12.Secondary Outcome
Title Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Hide Description Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.
Time Frame At Month 6 (Day 182) after Dose 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables at Month 6.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo ˃ 64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
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.
Overall Number of Participants Analyzed 366 37 40 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
36.2
(31.0 to 42.2)
5.5
(4.8 to 6.5)
44.8
(33.3 to 60.4)
5.4
(4.6 to 6.3)
13.Secondary Outcome
Title Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Hide Description 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.
Time Frame At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Influenza A (H5N1) >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
Overall Number of Participants Analyzed 188 46
Measure Type: Number
Unit of Measure: Subjects
A/Indonesia/5/05 177 36
A/Vietnam/1194/04 113 12
14.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Hide Description Titers were expressed as Geometric Mean Titers (GMTs).
Time Frame At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.
Arm/Group Title Influenza A (H5N1) 18-64Y Group Influenza A (H5N1) >64Y Group
Hide Arm/Group Description:
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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.
Overall Number of Participants Analyzed 188 46
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Indonesia/5/05, Day 0
22.4
(19.9 to 25.3)
52.4
(39.2 to 69.8)
A/Indonesia/5/05, Day 42
1450.6
(1266.9 to 1660.9)
631.1
(444.5 to 896.1)
A/Vietnam/1194/04, Day 0
29.9
(25.7 to 34.9)
94.4
(68.4 to 130.3)
A/Vietnam/1194/04, Day 42
163.1
(145.6 to 182.8)
213.4
(165.5 to 275.1)
Time Frame SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Hide Arm/Group Description Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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. 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. Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, 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. 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.
All-Cause Mortality
Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/2304 (1.04%)   7/768 (0.91%)   43/1118 (3.85%)   14/371 (3.77%) 
Blood and lymphatic system disorders         
Febrile neutropenia * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Lymphoma * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Cardiac disorders         
Myocardial infarction * 1  1/2304 (0.04%)  0/768 (0.00%)  3/1118 (0.27%)  2/371 (0.54%) 
Atrial fibrillation * 1  1/2304 (0.04%)  0/768 (0.00%)  2/1118 (0.18%)  1/371 (0.27%) 
Coronary artery disease * 1  0/2304 (0.00%)  1/768 (0.13%)  1/1118 (0.09%)  1/371 (0.27%) 
Acute coronary syndrome * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  2/371 (0.54%) 
Angina unstable * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  1/371 (0.27%) 
Coronary artery stenosis * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  2/371 (0.54%) 
Diastolic dysfunction * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  1/371 (0.27%) 
Acute myocardial infarction * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Cardiac disorder * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Cardiac failure congestive * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Cholangitis suppurative * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Hypertrophic cardiomyopathy * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Hypotension * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Left atrial dilatation * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Sick sinus syndrome * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Congenital, familial and genetic disorders         
Atrial septal defect * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Cardiomegaly * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Endocrine disorders         
Hyperthyroidism * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Gastrointestinal disorders         
Abdominal hernia * 1  2/2304 (0.09%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Intestinal obstruction * 1  0/2304 (0.00%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Large intestine perforation * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  1/371 (0.27%) 
Small intestinal obstruction * 1  1/2304 (0.04%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Abdominal pain * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Caecitis * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Colitis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Diarrhoea * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Dyspepsia * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Gallbladder disorder * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Gastritis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Gastrointestinal haemorrhage * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Gastrooesophageal reflux disease * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Ileus * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Lower gastrointestinal haemorrhage * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
General disorders         
Chest pain * 1  3/2304 (0.13%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Mountain sickness acute * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Non-cardiac chest pain * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Syncope * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Transplant rejection * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Hepatobiliary disorders         
Biliary dyskinesia * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Cholelithiasis * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Liver disorder * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Immune system disorders         
Anaphylactic reaction * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Infections and infestations         
Pneumonia * 1  1/2304 (0.04%)  0/768 (0.00%)  4/1118 (0.36%)  2/371 (0.54%) 
Cellulitis * 1  1/2304 (0.04%)  1/768 (0.13%)  1/1118 (0.09%)  0/371 (0.00%) 
Appendicitis * 1  0/2304 (0.00%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Diverticulitis * 1  0/2304 (0.00%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Sepsis * 1  1/2304 (0.04%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Staphylococcal infection * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Arthritis bacterial * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Cholecystitis * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Colitis ischaemic * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Diarrhoea infectious * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Enteritis * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
HIV test positive * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Hepatitis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Herpes zoster * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Pneumonia bacterial * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Pneumonia pneumococcal * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Subcutaneous abscess * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Viral infection * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Contusion * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Fibula fracture * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Forearm fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Hip fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Humerus fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Meniscus lesion * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Rib fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Spinal compression fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Spinal cord compression * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Tibia fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Ulna fracture * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Metabolism and nutrition disorders         
Diabetes mellitus * 1  1/2304 (0.04%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Diabetic complication * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Diabetic ketoacidosis * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Gout * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Pancreatitis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis * 1  0/2304 (0.00%)  1/768 (0.13%)  3/1118 (0.27%)  1/371 (0.27%) 
Back pain * 1  0/2304 (0.00%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Intervertebral disc protrusion * 1  2/2304 (0.09%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Arthralgia * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Hiatus hernia * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Muscle strain * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Musculoskeletal pain * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Nasal septum deviation * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Rotator cuff syndrome * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Spinal column stenosis * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Spondylolisthesis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Thyroid cancer * 1  1/2304 (0.04%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Breast cancer * 1  1/2304 (0.04%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Lung neoplasm malignant * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  1/371 (0.27%) 
Brain neoplasm malignant * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Breast cancer recurrent * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Colon cancer * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Hamartoma * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Lymph node cancer metastatic * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Melaena * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Metastases to liver * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Neoplasm malignant * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Ovarian cancer metastatic * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Rectal cancer stage 0 * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Renal cancer * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Seminoma * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Tongue carcinoma stage I * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Tongue neoplasm malignant stage unspecified * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Toxic nodular goitre * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Nervous system disorders         
Cerebrovascular accident * 1  0/2304 (0.00%)  1/768 (0.13%)  3/1118 (0.27%)  0/371 (0.00%) 
Convulsion * 1  2/2304 (0.09%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Transient ischaemic attack * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  1/371 (0.27%) 
Carotid artery dissection * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Migraine * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Radiculitis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous * 1  2/2304 (0.09%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Psychiatric disorders         
Affective disorder * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Depression * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Hypersensitivity * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Major depression * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Mania * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Mental disorder * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Mental status changes * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Renal and urinary disorders         
Calculus bladder * 1  1/2304 (0.04%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Nephrolithiasis * 1  0/2304 (0.00%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Pyelonephritis * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Renal failure * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Renal failure acute * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Renal tubular acidosis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Renal vessel disorder * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Urinary retention postoperative * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Urinary tract infection * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism * 1  1/2304 (0.04%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Bronchitis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Neonatal respiratory failure * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Tracheobronchitis * 1  0/2304 (0.00%)  1/768 (0.13%)  0/1118 (0.00%)  0/371 (0.00%) 
Skin and subcutaneous tissue disorders         
Synovial cyst * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Surgical and medical procedures         
Biopsy liver normal * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Vascular disorders         
Deep vein thrombosis * 1  0/2304 (0.00%)  0/768 (0.00%)  2/1118 (0.18%)  0/371 (0.00%) 
Aneurysm * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Aortic aneurysm * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Carotid artery stenosis * 1  0/2304 (0.00%)  0/768 (0.00%)  1/1118 (0.09%)  0/371 (0.00%) 
Coronary artery occlusion * 1  0/2304 (0.00%)  0/768 (0.00%)  0/1118 (0.00%)  1/371 (0.27%) 
Ischaemic stroke * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
Peripheral vascular disorder * 1  1/2304 (0.04%)  0/768 (0.00%)  0/1118 (0.00%)  0/371 (0.00%) 
*
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) 18-64Y Group Placebo 18-64Y Group Influenza A (H5N1) >64Y Group Placebo >64Y Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2087/2304 (90.58%)   405/768 (52.73%)   866/1118 (77.46%)   141/371 (38.01%) 
General disorders         
Pain  1  2024/2267 (89.28%)  171/754 (22.68%)  784/1109 (70.69%)  53/368 (14.40%) 
Redness  1  181/2267 (7.98%)  7/754 (0.93%)  106/1109 (9.56%)  1/368 (0.27%) 
Swelling  1  241/2267 (10.63%)  7/754 (0.93%)  110/1109 (9.92%)  1/368 (0.27%) 
Fatigue  1  890/2266 (39.28%)  189/755 (25.03%)  258/1109 (23.26%)  64/371 (17.25%) 
Headache  1  932/2266 (41.13%)  249/755 (32.98%)  247/1109 (22.27%)  63/371 (16.98%) 
Joint pain at other location  1  645/2266 (28.46%)  97/755 (12.85%)  208/1109 (18.76%)  39/371 (10.51%) 
Muscle aches  1  1188/2266 (52.43%)  175/755 (23.18%)  338/1109 (30.48%)  56/371 (15.09%) 
Shivering  1  456/2266 (20.12%)  87/755 (11.52%)  107/1109 (9.65%)  22/371 (5.93%) 
Sweating  1  314/2266 (13.86%)  67/755 (8.87%)  48/1109 (4.33%)  15/371 (4.04%) 
Temperature (Oral)  1  121/2266 (5.34%)  32/755 (4.24%)  35/1109 (3.16%)  6/371 (1.62%) 
Infections and infestations         
Nasopharyngitis * 1  116/2304 (5.03%)  29/768 (3.78%)  40/1118 (3.58%)  11/371 (2.96%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  91/2304 (3.95%)  39/768 (5.08%)  34/1118 (3.04%)  12/371 (3.23%) 
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00616928     History of Changes
Other Study ID Numbers: 110464
First Submitted: January 28, 2008
First Posted: February 15, 2008
Results First Submitted: December 19, 2013
Results First Posted: February 7, 2014
Last Update Posted: June 8, 2018