Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00616928
Collaborator
(none)
4,561
40
10
13.8
114
8.2
Study Details
Study Description
Brief Summary
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4561 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
Study Start Date
:
Jan 23, 2008
Actual Primary Completion Date
:
Oct 15, 2008
Actual Study Completion Date
:
Mar 19, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Influenza A (H5N1) 18-64Y Group Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
|
| Placebo Comparator: Placebo 18-64Y Group Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Placebo
Two intramuscular injections at Days 0 and 21.
|
| Experimental: Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
|
| Placebo Comparator: Placebo >64Y Group Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Placebo
Two intramuscular injections at Days 0 and 21.
|
| Experimental: Influenza A (H5N1) Group Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
|
| Placebo Comparator: Placebo Group Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Placebo
Two intramuscular injections at Days 0 and 21.
|
| Experimental: Influenza A (H5N1) 18-60Y Group Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
|
| Placebo Comparator: Placebo 18-60Y Group Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Placebo
Two intramuscular injections at Days 0 and 21.
|
| Experimental: Influenza A (H5N1) >60Y Group Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Two intramuscular injections at Days 0 and 21.
|
| Placebo Comparator: Placebo >60Y Group Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. |
Biological: Placebo
Two intramuscular injections at Days 0 and 21.
|
Outcome Measures
Primary Outcome Measures
- Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) [At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)]
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
- Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) [At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)]
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
- Number of Subjects With Any Solicited Local Symptoms. [During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration]
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
- Number of Subjects With Any Solicited General Symptoms. [During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration]
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
- Number of Subjects With Any Unsolicited Adverse Events (AEs). [During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)]
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Number of Subjects With Serious Adverse Events (SAEs) [From Day 0 through Day 182 and through Day 379.]
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
- Number of Subjects With Medically Attended Events (MAEs) [From Day 0 through Day 182 and through Day 364.]
Secondary Outcome Measures
- Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10 [At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)]
- Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10 [At Month 6 (Day 182) post Dose 1]
- Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) [At Month 6 (Day 182) after Dose 1]
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
- Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) [At Month 6 (Day 182) after Dose 1]
- Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1) [At Month 6 (Day 182) after Dose 1]
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.
- Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays. [At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)]
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays [At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)]
Titers were expressed as Geometric Mean Titers (GMTs).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
A male or female 18 years of age or greater at the time of the first vaccination.
-
Written informed consent obtained from the subject.
-
Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
-
Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
-
Access to a consistent means of telephone contact.
-
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Exclusion Criteria:
-
Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
-
Diagnosed with cancer, or treatment for cancer, within 3 years.
-
An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
-
Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
-
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
-
Administration of any vaccines within 30 days before study enrollment.
-
Previous administration of any H5N1 vaccine.
-
Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
-
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
-
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
-
Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
-
Lactating or nursing.
-
Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
-
Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Huntsville | Alabama | United States | 35802 |
| 2 | GSK Investigational Site | Phoenix | Arizona | United States | 85020 |
| 3 | GSK Investigational Site | Anaheim | California | United States | 92801 |
| 4 | GSK Investigational Site | Jacksonville | Florida | United States | 32216 |
| 5 | GSK Investigational Site | Melbourne | Florida | United States | 32935 |
| 6 | GSK Investigational Site | Miami | Florida | United States | 33143 |
| 7 | GSK Investigational Site | Pembroke Pines | Florida | United States | 33024 |
| 8 | GSK Investigational Site | Stockbridge | Georgia | United States | 30281 |
| 9 | GSK Investigational Site | Chicago | Illinois | United States | 60610 |
| 10 | GSK Investigational Site | Peoria | Illinois | United States | 61602 |
| 11 | GSK Investigational Site | South Bend | Indiana | United States | 46601 |
| 12 | GSK Investigational Site | Lenexa | Kansas | United States | 66219 |
| 13 | GSK Investigational Site | Wichita | Kansas | United States | 67207 |
| 14 | GSK Investigational Site | Metairie | Louisiana | United States | 70006 |
| 15 | GSK Investigational Site | Rockville | Maryland | United States | 20850 |
| 16 | GSK Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 17 | GSK Investigational Site | Missoula | Montana | United States | 59801 |
| 18 | GSK Investigational Site | Las Vegas | Nevada | United States | 89104 |
| 19 | GSK Investigational Site | Edison | New Jersey | United States | 08817 |
| 20 | GSK Investigational Site | Poughkeepsie | New York | United States | 12601 |
| 21 | GSK Investigational Site | Rochester | New York | United States | 14609 |
| 22 | GSK Investigational Site | Raleigh | North Carolina | United States | 27612 |
| 23 | GSK Investigational Site | Cleveland | Ohio | United States | 44122 |
| 24 | GSK Investigational Site | Erie | Pennsylvania | United States | 16506 |
| 25 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15236 |
| 26 | GSK Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 27 | GSK Investigational Site | Nashville | Tennessee | United States | 37203 |
| 28 | GSK Investigational Site | Austin | Texas | United States | 78705 |
| 29 | GSK Investigational Site | Fort Worth | Texas | United States | 76135 |
| 30 | GSK Investigational Site | San Angelo | Texas | United States | 76904 |
| 31 | GSK Investigational Site | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 32 | GSK Investigational Site | Truro | Nova Scotia | Canada | B2N 1L2 |
| 33 | GSK Investigational Site | London | Ontario | Canada | N5W 6A2 |
| 34 | GSK Investigational Site | Sarnia | Ontario | Canada | N7T 4X3 |
| 35 | GSK Investigational Site | Sudbury | Ontario | Canada | P3E 6C3 |
| 36 | GSK Investigational Site | Woodstock | Ontario | Canada | N4S 4G3 |
| 37 | GSK Investigational Site | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 38 | GSK Investigational Site | Quebec City | Quebec | Canada | G1E 7G9 |
| 39 | GSK Investigational Site | Sherbrooke | Quebec | Canada | J1H 4J6 |
| 40 | GSK Investigational Site | St-Romuald | Quebec | Canada | G6W 5M6 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00616928
Other Study ID Numbers:
- 110464
First Posted:
Feb 15, 2008
Last Update Posted:
Jun 8, 2018
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Influenza A (H5N1) 18-64Y Group | Placebo 18-64Y Group | Influenza A (H5N1) >64Y Group | Placebo >64Y Group |
|---|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Influenza A (H5N1) 18-64Y Group | Placebo 18-64Y Group | Influenza A (H5N1) >64Y Group | Placebo >64Y Group | Total |
|---|---|---|---|---|---|
| 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 Participants | 2304 | 768 | 1118 | 371 | 4561 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
38.5
(13.64)
|
38.7
(13.58)
|
71.9
(5.49)
|
72.1
(5.41)
|
49.5
(19.50)
|
| Sex: Female, Male (Count of 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%
|
Outcome Measures
| Title | Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 1571 | 76 | 396 | 40 |
| Number [Subjects] |
1427
|
1
|
293
|
1
|
| Title | Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 1571 | 76 | 396 | 40 |
| Day 0 |
5
|
0
|
9
|
0
|
| Day 42 |
1467
|
1
|
334
|
1
|
| Title | Number of Subjects With Any Solicited Local Symptoms. |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 2267 | 754 | 1109 | 368 | 3376 | 1122 |
| Pain |
2024
|
171
|
784
|
53
|
2808
|
224
|
| Redness |
181
|
7
|
106
|
1
|
287
|
8
|
| Swelling |
241
|
7
|
110
|
1
|
351
|
8
|
| Title | Number of Subjects With Any Solicited General Symptoms. |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|
| 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. |
| Measure Participants | 2266 | 755 | 1109 | 368 | 3375 | 1123 |
| 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
|
| Title | Number of Subjects With Any Unsolicited Adverse Events (AEs). |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 2304 | 768 | 1118 | 371 |
| Unsolicited AEs Days 0-21 |
914
|
289
|
399
|
113
|
| Unsolicited AEs Days 0-84 |
1017
|
321
|
467
|
130
|
| Title | Number of Subjects With Serious Adverse Events (SAEs) |
|---|---|
| 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. |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 2304 | 768 | 1118 | 371 |
| Subjects with SAEs Days 0-182 |
24
|
7
|
43
|
14
|
| Subjects with SAEs Days 0-379 |
46
|
15
|
65
|
30
|
| Title | Number of Subjects With Medically Attended Events (MAEs) |
|---|---|
| Description | |
| Time Frame | From Day 0 through Day 182 and through Day 364. |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 2304 | 768 | 1118 | 371 |
| Subjects with MAEs Days 0-182 |
480
|
154
|
298
|
92
|
| Subjects with MAEs Days 0-379 |
627
|
212
|
400
|
134
|
| Title | Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10 |
|---|---|
| Description | |
| Time Frame | At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 1488 | 68 | 479 | 48 |
| Number [Subjects] |
1391
|
1
|
410
|
1
|
| Title | Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10 |
|---|---|
| Description | |
| Time Frame | At Month 6 (Day 182) post Dose 1 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 366 | 37 | 91 | 19 |
| Number [Subjects] |
258
|
2
|
77
|
1
|
| Title | Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 366 | 37 | 91 | 19 |
| Number [Subjects] |
225
|
1
|
59
|
0
|
| Title | Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) |
|---|---|
| Description | |
| Time Frame | At Month 6 (Day 182) after Dose 1 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 366 | 37 | 91 | 19 |
| Number [Subjects] |
225
|
1
|
60
|
0
|
| Title | Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 366 | 37 | 40 | 19 |
| Geometric Mean (95% Confidence Interval) [Titers] |
36.2
|
5.5
|
44.8
|
5.4
|
| Title | Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays. |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 188 | 46 |
| A/Indonesia/5/05 |
177
|
36
|
| A/Vietnam/1194/04 |
113
|
12
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 188 | 46 |
| A/Indonesia/5/05, Day 0 |
22.4
|
52.4
|
| A/Indonesia/5/05, Day 42 |
1450.6
|
631.1
|
| A/Vietnam/1194/04, Day 0 |
29.9
|
94.4
|
| A/Vietnam/1194/04, Day 42 |
163.1
|
213.4
|
Adverse Events
| 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 | ||||||||
| Arm/Group Title | Influenza A (H5N1) 18-64Y Group | Placebo 18-64Y Group | Influenza A (H5N1) >64Y Group | Placebo >64Y Group | ||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Influenza A (H5N1) 18-64Y Group | Placebo 18-64Y Group | Influenza A (H5N1) >64Y Group | Placebo >64Y Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/2304 (1%) | 7/768 (0.9%) | 43/1118 (3.8%) | 14/371 (3.8%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Febrile neutropenia | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Lymphoma | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Cardiac disorders | ||||||||
| Myocardial infarction | 1/2304 (0%) | 0/768 (0%) | 3/1118 (0.3%) | 2/371 (0.5%) | ||||
| Atrial fibrillation | 1/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 1/371 (0.3%) | ||||
| Coronary artery disease | 0/2304 (0%) | 1/768 (0.1%) | 1/1118 (0.1%) | 1/371 (0.3%) | ||||
| Acute coronary syndrome | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 2/371 (0.5%) | ||||
| Angina unstable | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 1/371 (0.3%) | ||||
| Coronary artery stenosis | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 2/371 (0.5%) | ||||
| Diastolic dysfunction | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 1/371 (0.3%) | ||||
| Acute myocardial infarction | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Cardiac disorder | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Cardiac failure congestive | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Cholangitis suppurative | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Hypertrophic cardiomyopathy | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Hypotension | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Left atrial dilatation | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Sick sinus syndrome | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Atrial septal defect | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Cardiomegaly | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Endocrine disorders | ||||||||
| Hyperthyroidism | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal hernia | 2/2304 (0.1%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Intestinal obstruction | 0/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Large intestine perforation | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 1/371 (0.3%) | ||||
| Small intestinal obstruction | 1/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Abdominal pain | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Caecitis | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Colitis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Diarrhoea | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Dyspepsia | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Gallbladder disorder | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Gastritis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Gastrointestinal haemorrhage | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Gastrooesophageal reflux disease | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Ileus | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Lower gastrointestinal haemorrhage | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| General disorders | ||||||||
| Chest pain | 3/2304 (0.1%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Mountain sickness acute | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Non-cardiac chest pain | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Syncope | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Transplant rejection | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Biliary dyskinesia | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Cholelithiasis | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Liver disorder | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Immune system disorders | ||||||||
| Anaphylactic reaction | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Infections and infestations | ||||||||
| Pneumonia | 1/2304 (0%) | 0/768 (0%) | 4/1118 (0.4%) | 2/371 (0.5%) | ||||
| Cellulitis | 1/2304 (0%) | 1/768 (0.1%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Appendicitis | 0/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Diverticulitis | 0/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Sepsis | 1/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Staphylococcal infection | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Arthritis bacterial | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Cholecystitis | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Colitis ischaemic | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Diarrhoea infectious | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Enteritis | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| HIV test positive | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Hepatitis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Herpes zoster | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Pneumonia bacterial | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Pneumonia pneumococcal | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Subcutaneous abscess | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Viral infection | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Ankle fracture | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Contusion | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Fibula fracture | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Forearm fracture | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Hip fracture | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Humerus fracture | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Meniscus lesion | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Rib fracture | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Spinal compression fracture | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Spinal cord compression | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Tibia fracture | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Ulna fracture | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Diabetes mellitus | 1/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Diabetic complication | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Diabetic ketoacidosis | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Gout | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Pancreatitis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Osteoarthritis | 0/2304 (0%) | 1/768 (0.1%) | 3/1118 (0.3%) | 1/371 (0.3%) | ||||
| Back pain | 0/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Intervertebral disc protrusion | 2/2304 (0.1%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Arthralgia | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Hiatus hernia | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Muscle strain | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Musculoskeletal pain | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Nasal septum deviation | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Rotator cuff syndrome | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Spinal column stenosis | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Spondylolisthesis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Thyroid cancer | 1/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Breast cancer | 1/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Lung neoplasm malignant | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 1/371 (0.3%) | ||||
| Brain neoplasm malignant | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Breast cancer recurrent | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Colon cancer | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Hamartoma | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Lymph node cancer metastatic | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Melaena | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Metastases to liver | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Neoplasm malignant | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Ovarian cancer metastatic | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Rectal cancer stage 0 | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Renal cancer | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Seminoma | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Tongue carcinoma stage I | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Tongue neoplasm malignant stage unspecified | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Toxic nodular goitre | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Nervous system disorders | ||||||||
| Cerebrovascular accident | 0/2304 (0%) | 1/768 (0.1%) | 3/1118 (0.3%) | 0/371 (0%) | ||||
| Convulsion | 2/2304 (0.1%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Transient ischaemic attack | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 1/371 (0.3%) | ||||
| Carotid artery dissection | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Migraine | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Radiculitis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Abortion spontaneous | 2/2304 (0.1%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Psychiatric disorders | ||||||||
| Affective disorder | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Depression | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Hypersensitivity | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Major depression | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Mania | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Mental disorder | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Mental status changes | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Renal and urinary disorders | ||||||||
| Calculus bladder | 1/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Nephrolithiasis | 0/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Pyelonephritis | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Renal failure | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Renal failure acute | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Renal tubular acidosis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Renal vessel disorder | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Urinary retention postoperative | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Urinary tract infection | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pulmonary embolism | 1/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Bronchitis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Chronic obstructive pulmonary disease | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Neonatal respiratory failure | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Tracheobronchitis | 0/2304 (0%) | 1/768 (0.1%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Synovial cyst | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Surgical and medical procedures | ||||||||
| Biopsy liver normal | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Vascular disorders | ||||||||
| Deep vein thrombosis | 0/2304 (0%) | 0/768 (0%) | 2/1118 (0.2%) | 0/371 (0%) | ||||
| Aneurysm | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Aortic aneurysm | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Carotid artery stenosis | 0/2304 (0%) | 0/768 (0%) | 1/1118 (0.1%) | 0/371 (0%) | ||||
| Coronary artery occlusion | 0/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 1/371 (0.3%) | ||||
| Ischaemic stroke | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
| Peripheral vascular disorder | 1/2304 (0%) | 0/768 (0%) | 0/1118 (0%) | 0/371 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Influenza A (H5N1) 18-64Y Group | Placebo 18-64Y Group | Influenza A (H5N1) >64Y Group | Placebo >64Y Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2087/2304 (90.6%) | 405/768 (52.7%) | 866/1118 (77.5%) | 141/371 (38%) | ||||
| General disorders | ||||||||
| Pain | 2024/2267 (89.3%) | 171/754 (22.7%) | 784/1109 (70.7%) | 53/368 (14.4%) | ||||
| Redness | 181/2267 (8%) | 7/754 (0.9%) | 106/1109 (9.6%) | 1/368 (0.3%) | ||||
| Swelling | 241/2267 (10.6%) | 7/754 (0.9%) | 110/1109 (9.9%) | 1/368 (0.3%) | ||||
| Fatigue | 890/2266 (39.3%) | 189/755 (25%) | 258/1109 (23.3%) | 64/371 (17.3%) | ||||
| Headache | 932/2266 (41.1%) | 249/755 (33%) | 247/1109 (22.3%) | 63/371 (17%) | ||||
| Joint pain at other location | 645/2266 (28.5%) | 97/755 (12.8%) | 208/1109 (18.8%) | 39/371 (10.5%) | ||||
| Muscle aches | 1188/2266 (52.4%) | 175/755 (23.2%) | 338/1109 (30.5%) | 56/371 (15.1%) | ||||
| Shivering | 456/2266 (20.1%) | 87/755 (11.5%) | 107/1109 (9.6%) | 22/371 (5.9%) | ||||
| Sweating | 314/2266 (13.9%) | 67/755 (8.9%) | 48/1109 (4.3%) | 15/371 (4%) | ||||
| Temperature (Oral) | 121/2266 (5.3%) | 32/755 (4.2%) | 35/1109 (3.2%) | 6/371 (1.6%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 116/2304 (5%) | 29/768 (3.8%) | 40/1118 (3.6%) | 11/371 (3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Oropharyngeal pain | 91/2304 (3.9%) | 39/768 (5.1%) | 34/1118 (3%) | 12/371 (3.2%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Other Study ID Numbers:
- 110464
First Posted:
Feb 15, 2008
Last Update Posted:
Jun 8, 2018
Last Verified:
Oct 1, 2016