Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00753272
Collaborator
(none)
43,695
274
2
27.7
159.5
5.8
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.
After the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in Romania, which enrolled 102 subjects in the trial. Because evaluation of data from this site did not reveal irregularities when compared with overall study data and because GSK has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.
Study Design
Study Type:
Interventional
Actual Enrollment
:
43695 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Actual Study Start Date
:
Sep 15, 2008
Actual Primary Completion Date
:
Jun 18, 2010
Actual Study Completion Date
:
Jan 5, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FluNG Group subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
Biological: GSK Bio's influenza vaccine GSK2186877A
IM administration, two times one annual dose, 3 different lots will be tested
|
| Active Comparator: Fluarix Group subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
Biological: Fluarix TM
IM administration, two times one annual dose
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. [After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))]
Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.
- Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. [At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study]
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.
Secondary Outcome Measures
- Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. [During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)]
Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.
- Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection. [During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)]
Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.
- Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. [During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)]
Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough. The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).
- Number of Subjects Reporting All-cause Death After the First Dose of Vaccine. [During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)]
The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).
- Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine [During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)]
Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)]
Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)]
Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). [During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)]
Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination
- Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs). [During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)]
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = event assessed by the investigator as causally related to the study vaccination
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms. [During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)]
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter
- Number of Days With Any Grade of Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)]
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)]
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter
- Number of Days With Any Grade of Solicited Local Symptoms. [During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)]
Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)]
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.
- Number of Days With Any Grade of Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)]
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)]
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.
- Number of Days With Any Grade of Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)]
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [Within 21 days (Days 0-20) after the first dose (Year 2008/2009)]
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [Within 21 days (Days 0-20) after the second dose (Year 2009/2010)]
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit [Within 180 days (Days 0-179) after the first dose (Year 2008/2009)]
For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit. [Within 180 days (Days 0-179) after the second dose (Year 2009/2010)]
For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
- Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study]
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.
- Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains [At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study]
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.
- Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study]
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.
- Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. [At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study]
Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.
- Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains [At Day 21 of the first year (2008/2009) of the study.]
In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
-
A man or woman aged 65 years or older at the time of the vaccination.
-
Written informed consent obtained from the subject.
-
Subjects with residence status allowing free mixing with general community.
Exclusion Criteria:
-
Bedridden subjects
-
Previous vaccination against influenza since February 2008.
-
Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-
Any contra-indication to intramuscular administration of the influenza vaccines.
-
History of hypersensitivity to a previous dose of influenza vaccine.
-
History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
-
Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Alabaster | Alabama | United States | 35007 |
| 2 | GSK Investigational Site | Huntsville | Alabama | United States | 35802 |
| 3 | GSK Investigational Site | Mobile | Alabama | United States | 36608 |
| 4 | GSK Investigational Site | Chandler | Arizona | United States | 85224 |
| 5 | GSK Investigational Site | Mesa | Arizona | United States | 85203 |
| 6 | GSK Investigational Site | Mesa | Arizona | United States | 85213 |
| 7 | GSK Investigational Site | Phoenix | Arizona | United States | 85020 |
| 8 | GSK Investigational Site | Phoenix | Arizona | United States | 85028 |
| 9 | GSK Investigational Site | Phoenix | Arizona | United States | 85050 |
| 10 | GSK Investigational Site | Tempe | Arizona | United States | 85283 |
| 11 | GSK Investigational Site | Hot Springs | Arkansas | United States | 71901 |
| 12 | GSK Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 13 | GSK Investigational Site | Anaheim | California | United States | 92801 |
| 14 | GSK Investigational Site | Santa Ana | California | United States | 92705 |
| 15 | GSK Investigational Site | Clearwater | Florida | United States | 33761 |
| 16 | GSK Investigational Site | Coral Gables | Florida | United States | 33134 |
| 17 | GSK Investigational Site | Crystal River | Florida | United States | 34429 |
| 18 | GSK Investigational Site | Delray Beach | Florida | United States | 33484 |
| 19 | GSK Investigational Site | Inverness | Florida | United States | 34452 |
| 20 | GSK Investigational Site | Jacksonville | Florida | United States | 32205 |
| 21 | GSK Investigational Site | Jacksonville | Florida | United States | 32216 |
| 22 | GSK Investigational Site | Pembroke Pines | Florida | United States | 33024 |
| 23 | GSK Investigational Site | Boise | Idaho | United States | 83642 |
| 24 | GSK Investigational Site | Peoria | Illinois | United States | 61602 |
| 25 | GSK Investigational Site | Overland Park | Kansas | United States | 66212 |
| 26 | GSK Investigational Site | Wichita | Kansas | United States | 67207 |
| 27 | GSK Investigational Site | Kansas City | Missouri | United States | 64114 |
| 28 | GSK Investigational Site | Saint Louis | Missouri | United States | 63104 |
| 29 | GSK Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 30 | GSK Investigational Site | Omaha | Nebraska | United States | 68134 |
| 31 | GSK Investigational Site | Las Vegas | Nevada | United States | 89104 |
| 32 | GSK Investigational Site | Hackensack | New Jersey | United States | 07601 |
| 33 | GSK Investigational Site | Somers Point | New Jersey | United States | 08244 |
| 34 | GSK Investigational Site | Camillus | New York | United States | 13031 |
| 35 | GSK Investigational Site | Endwell | New York | United States | 13760 |
| 36 | GSK Investigational Site | Johnson City | New York | United States | 13790 |
| 37 | GSK Investigational Site | Rochester | New York | United States | 14621 |
| 38 | GSK Investigational Site | Cary | North Carolina | United States | 27518 |
| 39 | GSK Investigational Site | Charlotte | North Carolina | United States | 28209 |
| 40 | GSK Investigational Site | Hickory | North Carolina | United States | 28601 |
| 41 | GSK Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 42 | GSK Investigational Site | Raleigh | North Carolina | United States | 27612 |
| 43 | GSK Investigational Site | Salisbury | North Carolina | United States | 28144 |
| 44 | GSK Investigational Site | Tabor City | North Carolina | United States | 28463 |
| 45 | GSK Investigational Site | Carnegie | Pennsylvania | United States | 15106 |
| 46 | GSK Investigational Site | Erie | Pennsylvania | United States | 16506 |
| 47 | GSK Investigational Site | Grove City | Pennsylvania | United States | 16127 |
| 48 | GSK Investigational Site | Jefferson Hills | Pennsylvania | United States | 15025 |
| 49 | GSK Investigational Site | Philadelphia | Pennsylvania | United States | 19102 |
| 50 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15205 |
| 51 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15236 |
| 52 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15241 |
| 53 | GSK Investigational Site | Uniontown | Pennsylvania | United States | 15401 |
| 54 | GSK Investigational Site | Upper Saint Clair | Pennsylvania | United States | 15241 |
| 55 | GSK Investigational Site | Warwick | Rhode Island | United States | 02886 |
| 56 | GSK Investigational Site | Charleston | South Carolina | United States | 29412 |
| 57 | GSK Investigational Site | North Myrtle Beach | South Carolina | United States | 29582 |
| 58 | GSK Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 59 | GSK Investigational Site | Houston | Texas | United States | 77030 |
| 60 | GSK Investigational Site | Salt Lake City | Utah | United States | 84109 |
| 61 | GSK Investigational Site | Salt Lake City | Utah | United States | 84121 |
| 62 | GSK Investigational Site | West Jordan | Utah | United States | 84088 |
| 63 | GSK Investigational Site | Marshfield | Wisconsin | United States | 54449 |
| 64 | GSK Investigational Site | Anthée | Belgium | 5520 | |
| 65 | GSK Investigational Site | Deinze | Belgium | 9800 | |
| 66 | GSK Investigational Site | Dour | Belgium | 7370 | |
| 67 | GSK Investigational Site | Drongen | Belgium | 9031 | |
| 68 | GSK Investigational Site | Gent | Belgium | 9000 | |
| 69 | GSK Investigational Site | Gozée | Belgium | 6534 | |
| 70 | GSK Investigational Site | Hamois (Natoye) | Belgium | 5360 | |
| 71 | GSK Investigational Site | Kerksken | Belgium | 9451 | |
| 72 | GSK Investigational Site | Libramont | Belgium | 6800 | |
| 73 | GSK Investigational Site | Linkebeek | Belgium | 1630 | |
| 74 | GSK Investigational Site | Maldegem | Belgium | 9990 | |
| 75 | GSK Investigational Site | Melsbroek | Belgium | 1820 | |
| 76 | GSK Investigational Site | Merelbeke | Belgium | 9820 | |
| 77 | GSK Investigational Site | Mettet | Belgium | 5640 | |
| 78 | GSK Investigational Site | Oostakker | Belgium | 9041 | |
| 79 | GSK Investigational Site | Waarschoot | Belgium | 9950 | |
| 80 | GSK Investigational Site | Coquitlam | British Columbia | Canada | V3K 3P4 |
| 81 | GSK Investigational Site | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 82 | GSK Investigational Site | Bay Roberts | Newfoundland and Labrador | Canada | A0A 1G0 |
| 83 | GSK Investigational Site | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 84 | GSK Investigational Site | Truro | Nova Scotia | Canada | B2N 1L2 |
| 85 | GSK Investigational Site | Brampton | Ontario | Canada | L6T 3T1 |
| 86 | GSK Investigational Site | Sudbury | Ontario | Canada | P3E 1H5 |
| 87 | GSK Investigational Site | Toronto | Ontario | Canada | M9W 4L6 |
| 88 | GSK Investigational Site | Gatineau | Quebec | Canada | J8Y 6S8 |
| 89 | GSK Investigational Site | Sherbrooke | Quebec | Canada | J1H 4J6 |
| 90 | GSK Investigational Site | St-Romulad | Quebec | Canada | G6W 5M6 |
| 91 | GSK Investigational Site | Quebec | Canada | G1W 4R4 | |
| 92 | GSK Investigational Site | Hradec Kralove | Czechia | 500 03 | |
| 93 | GSK Investigational Site | Jaroměř | Czechia | 551 02 | |
| 94 | GSK Investigational Site | Jaroměř | Czechia | ||
| 95 | GSK Investigational Site | Pardubice | Czechia | 530 02 | |
| 96 | GSK Investigational Site | Pardubice | Czechia | 530 12 | |
| 97 | GSK Investigational Site | Pardubice | Czechia | ||
| 98 | GSK Investigational Site | Saku | Estonia | 75501 | |
| 99 | GSK Investigational Site | Tallinn | Estonia | 10117 | |
| 100 | GSK Investigational Site | Tallinn | Estonia | 10617 | |
| 101 | GSK Investigational Site | Tallinn | Estonia | 13419 | |
| 102 | GSK Investigational Site | Tallinn | Estonia | 13619 | |
| 103 | GSK Investigational Site | Tartu | Estonia | 50106 | |
| 104 | GSK Investigational Site | Tartu | Estonia | 50410 | |
| 105 | GSK Investigational Site | Angers | France | 49000 | |
| 106 | GSK Investigational Site | Angers | France | 49100 | |
| 107 | GSK Investigational Site | Anzin | France | 59410 | |
| 108 | GSK Investigational Site | Arras | France | 62000 | |
| 109 | GSK Investigational Site | Bordeaux | France | 33200 | |
| 110 | GSK Investigational Site | Bécon les Granits | France | 49370 | |
| 111 | GSK Investigational Site | Cannes | France | 06400 | |
| 112 | GSK Investigational Site | Chambery | France | 73000 | |
| 113 | GSK Investigational Site | Château Gontier | France | 53200 | |
| 114 | GSK Investigational Site | Clermont-Ferrand | France | 63003 | |
| 115 | GSK Investigational Site | Ecouflant | France | 49000 | |
| 116 | GSK Investigational Site | Gresy sur Aix | France | 73100 | |
| 117 | GSK Investigational Site | La Rochelle | France | 17000 | |
| 118 | GSK Investigational Site | Laval | France | 53000 | |
| 119 | GSK Investigational Site | Le Fousseret | France | 31430 | |
| 120 | GSK Investigational Site | Montpellier Cedex 5 | France | 34295 | |
| 121 | GSK Investigational Site | Montreuil Juigne | France | 49460 | |
| 122 | GSK Investigational Site | Muret | France | 31600 | |
| 123 | GSK Investigational Site | Nieul sur Mer | France | 17137 | |
| 124 | GSK Investigational Site | Oignies | France | 62590 | |
| 125 | GSK Investigational Site | Orthez | France | 64300 | |
| 126 | GSK Investigational Site | Paris Cedex 18 | France | 75877 | |
| 127 | GSK Investigational Site | Paris | France | 75679 | |
| 128 | GSK Investigational Site | Rosiers d'Egletons | France | 19300 | |
| 129 | GSK Investigational Site | Saint Etienne | France | 42100 | |
| 130 | GSK Investigational Site | Segré | France | 49500 | |
| 131 | GSK Investigational Site | Seysses | France | 31600 | |
| 132 | GSK Investigational Site | Tierce | France | 49125 | |
| 133 | GSK Investigational Site | Tours | France | 37100 | |
| 134 | GSK Investigational Site | Vourey | France | 38210 | |
| 135 | GSK Investigational Site | Gueglingen | Baden-Wuerttemberg | Germany | 74363 |
| 136 | GSK Investigational Site | Mannheim | Baden-Wuerttemberg | Germany | 68161 |
| 137 | GSK Investigational Site | Messkirch | Baden-Wuerttemberg | Germany | 88605 |
| 138 | GSK Investigational Site | Rudersberg | Baden-Wuerttemberg | Germany | 73635 |
| 139 | GSK Investigational Site | Schwetzingen | Baden-Wuerttemberg | Germany | 68723 |
| 140 | GSK Investigational Site | Sinsheim | Baden-Wuerttemberg | Germany | 74889 |
| 141 | GSK Investigational Site | Tuebingen | Baden-Wuerttemberg | Germany | 72074 |
| 142 | GSK Investigational Site | Weinheim | Baden-Wuerttemberg | Germany | 69469 |
| 143 | GSK Investigational Site | Augsburg | Bayern | Germany | 86150 |
| 144 | GSK Investigational Site | Haag | Bayern | Germany | 83527 |
| 145 | GSK Investigational Site | Hoehenkirchen-Siegertsbrunn | Bayern | Germany | 85635 |
| 146 | GSK Investigational Site | Kuenzing | Bayern | Germany | 94550 |
| 147 | GSK Investigational Site | Muenchen | Bayern | Germany | 80339 |
| 148 | GSK Investigational Site | Muenchen | Bayern | Germany | 80636 |
| 149 | GSK Investigational Site | Rednitzhembach | Bayern | Germany | 91126 |
| 150 | GSK Investigational Site | Wuerzburg | Bayern | Germany | 97070 |
| 151 | GSK Investigational Site | Cottbus | Brandenburg | Germany | 03050 |
| 152 | GSK Investigational Site | Ketzin | Brandenburg | Germany | 14669 |
| 153 | GSK Investigational Site | Ruedersdorf | Brandenburg | Germany | 15562 |
| 154 | GSK Investigational Site | Bad Kreuznach | Hessen | Germany | 55545 |
| 155 | GSK Investigational Site | Floersheim | Hessen | Germany | 65439 |
| 156 | GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | Germany | 18057 |
| 157 | GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | Germany | 19055 |
| 158 | GSK Investigational Site | Brinkum/Stuhr | Niedersachsen | Germany | 28816 |
| 159 | GSK Investigational Site | Duelmen | Niedersachsen | Germany | 48249 |
| 160 | GSK Investigational Site | Koenigslutter | Niedersachsen | Germany | 38154 |
| 161 | GSK Investigational Site | Rotenburg (Wuemme) | Niedersachsen | Germany | 27356 |
| 162 | GSK Investigational Site | Bochum | Nordrhein-Westfalen | Germany | 44787 |
| 163 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45359 |
| 164 | GSK Investigational Site | Goch | Nordrhein-Westfalen | Germany | 47574 |
| 165 | GSK Investigational Site | Koeln | Nordrhein-Westfalen | Germany | 51063 |
| 166 | GSK Investigational Site | Koeln | Nordrhein-Westfalen | Germany | 51069 |
| 167 | GSK Investigational Site | Muenster | Nordrhein-Westfalen | Germany | 48155 |
| 168 | GSK Investigational Site | Witten | Nordrhein-Westfalen | Germany | 58455 |
| 169 | GSK Investigational Site | Ingelheim | Rheinland-Pfalz | Germany | 55218 |
| 170 | GSK Investigational Site | Kallstadt | Rheinland-Pfalz | Germany | 67169 |
| 171 | GSK Investigational Site | Mainz | Rheinland-Pfalz | Germany | 55116 |
| 172 | GSK Investigational Site | Mainz | Rheinland-Pfalz | Germany | 55131 |
| 173 | GSK Investigational Site | Rhaunen | Rheinland-Pfalz | Germany | 55624 |
| 174 | GSK Investigational Site | Koethen | Sachsen-Anhalt | Germany | 06366 |
| 175 | GSK Investigational Site | Magdeburg | Sachsen-Anhalt | Germany | 39104 |
| 176 | GSK Investigational Site | Magdeburg | Sachsen-Anhalt | Germany | 39112 |
| 177 | GSK Investigational Site | Wolmirstedt | Sachsen-Anhalt | Germany | 39326 |
| 178 | GSK Investigational Site | Borna | Sachsen | Germany | 04552 |
| 179 | GSK Investigational Site | Delitzsch | Sachsen | Germany | 04509 |
| 180 | GSK Investigational Site | Dresden | Sachsen | Germany | 01069 |
| 181 | GSK Investigational Site | Dresden | Sachsen | Germany | 01099 |
| 182 | GSK Investigational Site | Dresden | Sachsen | Germany | 01307 |
| 183 | GSK Investigational Site | Freiberg | Sachsen | Germany | 09599 |
| 184 | GSK Investigational Site | Freital | Sachsen | Germany | 01705 |
| 185 | GSK Investigational Site | Geringswalde | Sachsen | Germany | 09326 |
| 186 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04103 |
| 187 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04207 |
| 188 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04315 |
| 189 | GSK Investigational Site | Schmiedeberg | Sachsen | Germany | 01762 |
| 190 | GSK Investigational Site | Weissenberg | Sachsen | Germany | 02627 |
| 191 | GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein | Germany | 24576 |
| 192 | GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | Germany | 23795 |
| 193 | GSK Investigational Site | Luebeck | Schleswig-Holstein | Germany | 23554 |
| 194 | GSK Investigational Site | Erfurt | Thueringen | Germany | 99084 |
| 195 | GSK Investigational Site | Berlin | Germany | 10365 | |
| 196 | GSK Investigational Site | Berlin | Germany | 10367 | |
| 197 | GSK Investigational Site | Berlin | Germany | 10435 | |
| 198 | GSK Investigational Site | Berlin | Germany | 10629 | |
| 199 | GSK Investigational Site | Berlin | Germany | 10717 | |
| 200 | GSK Investigational Site | Berlin | Germany | 10777 | |
| 201 | GSK Investigational Site | Berlin | Germany | 10787 | |
| 202 | GSK Investigational Site | Berlin | Germany | 12157 | |
| 203 | GSK Investigational Site | Berlin | Germany | 12627 | |
| 204 | GSK Investigational Site | Berlin | Germany | 13086 | |
| 205 | GSK Investigational Site | Berlin | Germany | 13125 | |
| 206 | GSK Investigational Site | Berlin | Germany | 13347 | |
| 207 | GSK Investigational Site | Hamburg | Germany | 20246 | |
| 208 | GSK Investigational Site | Hamburg | Germany | 20253 | |
| 209 | GSK Investigational Site | Hamburg | Germany | 22143 | |
| 210 | GSK Investigational Site | Hamburg | Germany | 22335 | |
| 211 | GSK Investigational Site | Hamburg | Germany | 22339 | |
| 212 | GSK Investigational Site | Hamburg | Germany | 22415 | |
| 213 | GSK Investigational Site | Hamburg | Germany | 22769 | |
| 214 | GSK Investigational Site | Ecatepec de Morelos | Estado De México | Mexico | 55075 |
| 215 | GSK Investigational Site | Cuernavaca | Morelos | Mexico | |
| 216 | GSK Investigational Site | Monterrey | Nuevo León | Mexico | 64610 |
| 217 | GSK Investigational Site | Mexico | Mexico | 14000 | |
| 218 | GSK Investigational Site | Rotterdam | Netherlands | 3001 DC | |
| 219 | GSK Investigational Site | Rotterdam | Netherlands | 3011 EN | |
| 220 | GSK Investigational Site | Soest | Netherlands | 3762 BN | |
| 221 | GSK Investigational Site | Utrecht | Netherlands | 3584 CX | |
| 222 | GSK Investigational Site | Alesund | Norway | ||
| 223 | GSK Investigational Site | Bekkestua | Norway | 1319 | |
| 224 | GSK Investigational Site | Bergen | Norway | 5094 | |
| 225 | GSK Investigational Site | Elverum | Norway | 2408 | |
| 226 | GSK Investigational Site | Hamar | Norway | 2317 | |
| 227 | GSK Investigational Site | Oslo | Norway | 0277 | |
| 228 | GSK Investigational Site | Oslo | Norway | 0484 | |
| 229 | GSK Investigational Site | Skien | Norway | 3717 | |
| 230 | GSK Investigational Site | Stavanger | Norway | 4005 | |
| 231 | GSK Investigational Site | Bydgoszcz | Poland | 85-021 | |
| 232 | GSK Investigational Site | Debica | Poland | 39-200 | |
| 233 | GSK Investigational Site | Grodzisk Mazowiecki | Poland | 05-825 | |
| 234 | GSK Investigational Site | Ilawa | Poland | 14-200 | |
| 235 | GSK Investigational Site | Inowrocław | Poland | 88-100 | |
| 236 | GSK Investigational Site | Katowice | Poland | 40-018 | |
| 237 | GSK Investigational Site | Krakow | Poland | 30-695 | |
| 238 | GSK Investigational Site | Krakow | Poland | 31-135 | |
| 239 | GSK Investigational Site | Krakow | Poland | 31-305 | |
| 240 | GSK Investigational Site | Lubartow | Poland | 21-100 | |
| 241 | GSK Investigational Site | Olesnica | Poland | 56-400 | |
| 242 | GSK Investigational Site | Plock | Poland | 09-400 | |
| 243 | GSK Investigational Site | Porabka | Poland | 43-353 | |
| 244 | GSK Investigational Site | Siemianowice Slaskie | Poland | 41-103 | |
| 245 | GSK Investigational Site | Sopot | Poland | 81-741 | |
| 246 | GSK Investigational Site | Torun | Poland | 87-100 | |
| 247 | GSK Investigational Site | Trzebnica | Poland | 55-100 | |
| 248 | GSK Investigational Site | Tychy | Poland | 43-100 | |
| 249 | GSK Investigational Site | Wroclaw | Poland | 50-088 | |
| 250 | GSK Investigational Site | Braila | Romania | 810019 | |
| 251 | GSK Investigational Site | Braila | Romania | 810384 | |
| 252 | GSK Investigational Site | Brasov | Romania | 500014 | |
| 253 | GSK Investigational Site | Brasov | Romania | 500260 | |
| 254 | GSK Investigational Site | Brasov | Romania | 500366 | |
| 255 | GSK Investigational Site | Bucharest | Romania | 010194 | |
| 256 | GSK Investigational Site | Bucharest | Romania | 020142 | |
| 257 | GSK Investigational Site | Bucharest | Romania | 062289 | |
| 258 | GSK Investigational Site | Bucharest | Romania | 077190 | |
| 259 | GSK Investigational Site | Craiova | Romania | 200128 | |
| 260 | GSK Investigational Site | Galati | Romania | 800338 | |
| 261 | GSK Investigational Site | Galati | Romania | 800578 | |
| 262 | GSK Investigational Site | Pantelimon | Romania | 77145 | |
| 263 | GSK Investigational Site | Ploiesti | Romania | 100172 | |
| 264 | GSK Investigational Site | Barnaul | Russian Federation | 656056 | |
| 265 | GSK Investigational Site | Ekaterinburg | Russian Federation | 620137 | |
| 266 | GSK Investigational Site | Ekaterinburg | Russian Federation | ||
| 267 | GSK Investigational Site | Perm | Russian Federation | 614010 | |
| 268 | GSK Investigational Site | Perm | Russian Federation | 614087 | |
| 269 | GSK Investigational Site | Taipei | Taiwan | 100 | |
| 270 | GSK Investigational Site | Taipei | Taiwan | 112 | |
| 271 | GSK Investigational Site | Reading | Berkshire | United Kingdom | RG2 0TG |
| 272 | GSK Investigational Site | Buckshaw Village, Chorley | Lancashire | United Kingdom | PR7 7NA |
| 273 | GSK Investigational Site | Liverpool | Merseyside | United Kingdom | L22 0LG |
| 274 | GSK Investigational Site | Waterloo, Liverpool | United Kingdom | L22 0LG |
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:
NCT00753272
Other Study ID Numbers:
- 106372
First Posted:
Sep 16, 2008
Last Update Posted:
Jun 8, 2018
Last Verified:
Aug 1, 2017
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 | Subjects were vaccinated during the pre-influenza season at Day 0, were contacted by phone during the surveillance period from mid November to the end of the influenza season (April-May) and were contacted by phone at Days 270 and 365 for the Year 1 influenza season 2008/2009 and the Year 2 influenza season 2009/2010. |
|---|---|
| Pre-assignment Detail | For lot-to-lot consistency analyses after Dose 1 at Day 0 of the Year 1, FluNG Group was divided in 3 sub-groups: FluNG Lot 1 Group, FluNG Lot 2 Group and FluNG Lot 3 Group: subjects received 1 dose of FluNG vaccine Lot 1, 2 or 3 at Day 0 of the Year 1. They all received Dose 2 at Day 0 of the Year 2, again from 3 different lots. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Period Title: Overall Study | ||
| STARTED | 21893 | 21802 |
| COMPLETED | 16911 | 16895 |
| NOT COMPLETED | 4982 | 4907 |
Baseline Characteristics
| Arm/Group Title | FluNG Group | Fluarix Group | Total |
|---|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | Total of all reporting groups |
| Overall Participants | 21893 | 21802 | 43695 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
73.5
(6.09)
|
73.5
(6.16)
|
73.5
(6.13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12549
57.3%
|
12422
57%
|
24971
57.1%
|
| Male |
9344
42.7%
|
9380
43%
|
18724
42.9%
|
Outcome Measures
| Title | Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. |
|---|---|
| Description | Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis. |
| Time Frame | After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season)) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol cohort for efficacy included eligible subjects from the One-Dose Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21573 | 21482 |
| Count of Participants [Participants] |
274
1.3%
|
310
1.4%
|
| Title | Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. |
|---|---|
| Description | Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects. |
| Time Frame | At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset, which included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset. |
| Arm/Group Title | FluNG Lot 1 Group | FluNG Lot 2 Group | FluNG Lot 3 Group |
|---|---|---|---|
| Arm/Group Description | subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid. | subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid. | subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid. |
| Measure Participants | 540 | 538 | 534 |
| A/Brisbane [Day 0] |
15.9
|
15.8
|
15.8
|
| A/Brisbane [Day 21] |
82.3
|
83.6
|
93.4
|
| A/Uruguay [Day 0] |
18.2
|
17.8
|
17.3
|
| A/Uruguay [Day 21] |
272.5
|
287.5
|
269.9
|
| B/Brisbane[Day 0] |
94.2
|
89.9
|
87.1
|
| B/Brisbane[Day 21] |
652.4
|
596.9
|
601.7
|
| Title | Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. |
|---|---|
| Description | Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis. |
| Time Frame | During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 20579 | 20458 |
| Count of Participants [Participants] |
262
1.2%
|
296
1.4%
|
| Title | Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection. |
|---|---|
| Description | Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis. |
| Time Frame | During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 20579 | 20458 |
| Count of Participants [Participants] |
144
0.7%
|
145
0.7%
|
| Title | Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. |
|---|---|
| Description | Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough. The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). |
| Time Frame | During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21394 | 21337 |
| Count of Participants [Participants] |
202
0.9%
|
225
1%
|
| Title | Number of Subjects Reporting All-cause Death After the First Dose of Vaccine. |
|---|---|
| Description | The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). |
| Time Frame | During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21394 | 21337 |
| Count of Participants [Participants] |
63
0.3%
|
88
0.4%
|
| Title | Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine |
|---|---|
| Description | Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy. |
| Time Frame | During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21394 | 21337 |
| Count of Participants [Participants] |
84
0.4%
|
89
0.4%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). |
|---|---|
| Description | Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination |
| Time Frame | Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21893 | 21802 |
| Any AEs |
70
0.3%
|
60
0.3%
|
| Grade 3 AEs |
13
0.1%
|
8
0%
|
| Related AEs |
11
0.1%
|
7
0%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). |
|---|---|
| Description | Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination |
| Time Frame | Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 17070 | 17071 |
| Any AEs |
35
0.2%
|
40
0.2%
|
| Grade 3 AEs |
9
0%
|
6
0%
|
| Related AEs |
2
0%
|
0
0%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). |
|---|---|
| Description | Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination |
| Time Frame | During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21893 | 21802 |
| Any AEs |
103
0.5%
|
99
0.5%
|
| Grade 3 AEs |
22
0.1%
|
14
0.1%
|
| Related AEs |
13
0.1%
|
7
0%
|
| Title | Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs). |
|---|---|
| Description | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = event assessed by the investigator as causally related to the study vaccination |
| Time Frame | During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 21893 | 21802 |
| Any SAEs |
4071
18.6%
|
4066
18.6%
|
| Related SAEs |
9
0%
|
6
0%
|
| Title | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms. |
|---|---|
| Description | Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2988 | 2968 |
| Any ecchymosis |
40
0.2%
|
18
0.1%
|
| Ecchymosis > 100 mm |
0
0%
|
0
0%
|
| Any pain |
1225
5.6%
|
477
2.2%
|
| Grade 3 pain |
4
0%
|
3
0%
|
| Any redness |
240
1.1%
|
66
0.3%
|
| Redness > 100 mm |
6
0%
|
3
0%
|
| Any swelling |
189
0.9%
|
40
0.2%
|
| Swelling > 100 mm |
4
0%
|
0
0%
|
| Title | Number of Days With Any Grade of Solicited Local Symptoms |
|---|---|
| Description | Solicited local symptoms assessed were ecchymosis, pain, redness and swelling |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 1221 | 476 |
| Ecchymosis |
3.6
|
4.0
|
| Pain |
2.5
|
2.1
|
| Redness |
2.9
|
2.5
|
| Swelling |
2.9
|
2.0
|
| Title | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms |
|---|---|
| Description | Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2441 | 2488 |
| Any ecchymosis |
39
0.2%
|
31
0.1%
|
| Ecchymosis > 100 mm |
1
0%
|
0
0%
|
| Any pain |
998
4.6%
|
440
2%
|
| Grade 3 pain |
13
0.1%
|
7
0%
|
| Any redness |
212
1%
|
54
0.2%
|
| Redness > 100 mm |
4
0%
|
2
0%
|
| Any swelling |
173
0.8%
|
38
0.2%
|
| Swelling > 100 mm |
3
0%
|
0
0%
|
| Title | Number of Days With Any Grade of Solicited Local Symptoms. |
|---|---|
| Description | Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 995 | 431 |
| Ecchymosis |
2.8
|
3.6
|
| Pain |
2.5
|
2.0
|
| Redness |
2.8
|
2.6
|
| Swelling |
2.5
|
2.7
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms |
|---|---|
| Description | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2986 | 2968 |
| Any arthralgia |
391
1.8%
|
239
1.1%
|
| Grade 3 arthralgia |
11
0.1%
|
5
0%
|
| Related arthralgia |
285
1.3%
|
163
0.7%
|
| Any fatigue |
646
3%
|
417
1.9%
|
| Grade 3 fatigue |
20
0.1%
|
15
0.1%
|
| Related fatigue |
494
2.3%
|
295
1.4%
|
| Any gastrointestinal |
197
0.9%
|
165
0.8%
|
| Grade 3 gastrointestinal |
6
0%
|
4
0%
|
| Related gastrointestinal |
132
0.6%
|
82
0.4%
|
| Any headache |
474
2.2%
|
333
1.5%
|
| Grade 3 headache |
8
0%
|
4
0%
|
| Related headache |
341
1.6%
|
213
1%
|
| Any myalgia |
547
2.5%
|
302
1.4%
|
| Grade 3 myalgia |
14
0.1%
|
11
0.1%
|
| Related myalgia |
412
1.9%
|
203
0.9%
|
| Any shivering |
245
1.1%
|
80
0.4%
|
| Grade 3 shivering |
12
0.1%
|
2
0%
|
| Related shivering |
185
0.8%
|
49
0.2%
|
| Temperature >= 38.0°C |
72
0.3%
|
20
0.1%
|
| Temperature >= 39.0°C - <=40.0°C |
5
0%
|
2
0%
|
| Related temperature |
51
0.2%
|
14
0.1%
|
| Title | Number of Days With Any Grade of Solicited General Symptoms |
|---|---|
| Description | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 642 | 417 |
| Arthralgia |
2.8
|
2.9
|
| Fatigue |
2.5
|
2.7
|
| Gastrointestinal |
2.2
|
2.2
|
| Headache |
2.2
|
2.3
|
| Myalgia |
2.3
|
2.3
|
| Shivering |
1.6
|
2.1
|
| Temperature |
1.4
|
1.3
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms. |
|---|---|
| Description | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2436 | 2489 |
| Any arthralgia |
258
1.2%
|
176
0.8%
|
| Grade 3 arthralgia |
10
0%
|
4
0%
|
| Related arthralgia |
169
0.8%
|
90
0.4%
|
| Any fatigue |
457
2.1%
|
318
1.5%
|
| Grade 3 fatigue |
8
0%
|
6
0%
|
| Related fatigue |
307
1.4%
|
169
0.8%
|
| Any gastrointestinal |
137
0.6%
|
124
0.6%
|
| Grade 3 gastrointestinal |
5
0%
|
8
0%
|
| Related gastrointestinal |
71
0.3%
|
46
0.2%
|
| Any headache |
342
1.6%
|
237
1.1%
|
| Grade 3 headache |
10
0%
|
4
0%
|
| Related headache |
219
1%
|
119
0.5%
|
| Any myalgia |
380
1.7%
|
209
1%
|
| Grade 3 myalgia |
11
0.1%
|
6
0%
|
| Related myalgia |
261
1.2%
|
117
0.5%
|
| Any shivering |
189
0.9%
|
88
0.4%
|
| Grade 3 shivering |
11
0.1%
|
6
0%
|
| Related shivering |
127
0.6%
|
44
0.2%
|
| Temperature >= 38.0°C |
52
0.2%
|
25
0.1%
|
| Temperature >= 39.0°C - <= 40.0°C |
5
0%
|
2
0%
|
| Related temperature |
33
0.2%
|
7
0%
|
| Title | Number of Days With Any Grade of Solicited General Symptoms. |
|---|---|
| Description | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 446 | 313 |
| Arthralgia |
2.7
|
3.0
|
| Fatigue |
2.6
|
2.7
|
| Gastrointestinal |
2.3
|
2.6
|
| Headache |
2.2
|
2.4
|
| Myalgia |
2.4
|
2.6
|
| Shivering |
1.6
|
2.3
|
| Temperature |
1.2
|
1.5
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). |
|---|---|
| Description | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | Within 21 days (Days 0-20) after the first dose (Year 2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 3015 | 3002 |
| Any AEs |
428
2%
|
427
2%
|
| Grade 3 AEs |
48
0.2%
|
52
0.2%
|
| Related AEs |
83
0.4%
|
58
0.3%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). |
|---|---|
| Description | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | Within 21 days (Days 0-20) after the second dose (Year 2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2462 | 2520 |
| Any AEs |
320
1.5%
|
306
1.4%
|
| Grade 3 AEs |
36
0.2%
|
26
0.1%
|
| Related AEs |
42
0.2%
|
20
0.1%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit |
|---|---|
| Description | For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | Within 180 days (Days 0-179) after the first dose (Year 2008/2009) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 3015 | 3002 |
| Any AEs |
1018
4.6%
|
996
4.6%
|
| Grade 3 AEs |
223
1%
|
211
1%
|
| Related AEs |
16
0.1%
|
7
0%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit. |
|---|---|
| Description | For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | Within 180 days (Days 0-179) after the second dose (Year 2009/2010) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2462 | 2520 |
| Any AEs |
849
3.9%
|
864
4%
|
| Grade 3 AEs |
158
0.7%
|
154
0.7%
|
| Related AEs |
7
0%
|
5
0%
|
| Title | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. |
|---|---|
| Description | Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects. |
| Time Frame | At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the first year of the study. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 2422 | 2408 |
| A/Brisbane [Day 0] |
15.5
|
15.3
|
| A/Brisbane [Day 21] |
89.1
|
69.9
|
| A/Uruguay [Day 0] |
17.4
|
17.4
|
| A/Uruguay [Day 21] |
285.6
|
172.3
|
| B/Brisbane [Day 0] |
85.3
|
82.4
|
| B/Brisbane [Day 21] |
633.5
|
484.8
|
| Title | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains |
|---|---|
| Description | Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects. |
| Time Frame | At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the second year of the study. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 1938 | 1953 |
| A/Brisbane [Day 0] |
23.9
|
24.3
|
| A/Brisbane [Day 21] |
76.9
|
70.5
|
| A/Uruguay [Day 0] |
57.8
|
46.5
|
| A/Uruguay [Day 21] |
256.8
|
162.0
|
| B/Brisbane [Day 0] |
58.6
|
56.6
|
| B/Brisbane [Day 21] |
199.2
|
171.3
|
| Title | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. |
|---|---|
| Description | Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only. |
| Time Frame | At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 268 | 267 |
| A/Brisbane [Day 0] |
15.4
|
13.9
|
| A/Brisbane [Day 21] |
75.4
|
64.5
|
| A/Brisbane [Day 180] |
30.4
|
28.1
|
| A/Uruguay [Day 0] |
19.3
|
17.8
|
| A/Uruguay [Day 21] |
275.0
|
165.0
|
| A/Uruguay [Day 180] |
97.7
|
64.0
|
| B/Brisbane [Day 0] |
89.3
|
83.8
|
| B/Brisbane [Day 21] |
573.4
|
478.5
|
| B/Brisbane [Day 180] |
274.6
|
262.3
|
| Title | Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. |
|---|---|
| Description | Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only. |
| Time Frame | At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Two-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the second year of the study. |
| Arm/Group Title | FluNG Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). |
| Measure Participants | 189 | 177 |
| A/Brisbane [Day 0] |
23.4
|
25.0
|
| A/Brisbane [Day 21] |
80.0
|
75.0
|
| A/Brisbane [Day 180] |
28.5
|
27.3
|
| A/Uruguay [Day 0] |
68.9
|
54.2
|
| A/Uruguay [Day 21] |
300.6
|
195.6
|
| A/Uruguay [Day 180] |
105.7
|
63.6
|
| B/Brisbane [Day 0] |
58.5
|
56.1
|
| B/Brisbane [Day 21] |
225.1
|
191.0
|
| B/Brisbane [Day 180] |
122.9
|
111.6
|
| Title | Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains |
|---|---|
| Description | In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4. |
| Time Frame | At Day 21 of the first year (2008/2009) of the study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset. |
| Arm/Group Title | FluNG Lot 1 Group | FluNG Lot 2 Group | FluNG Lot 3 Group |
|---|---|---|---|
| Arm/Group Description | subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid. | subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid. | subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid. |
| Measure Participants | 539 | 536 | 532 |
| A/Brisbane |
307
1.4%
|
298
1.4%
|
310
0.7%
|
| A/Uruguay |
471
2.2%
|
461
2.1%
|
455
1%
|
| B/Brisbane |
389
1.8%
|
350
1.6%
|
363
0.8%
|
Adverse Events
| Time Frame | Solicited symptoms: During the 7-day post-vaccination period the first year (2008/2009) and the second year (2009/2010). SAEs: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | FluNG Group | Fluarix Group | ||
| Arm/Group Description | subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1). | ||
All Cause Mortality |
||||
| FluNG Group | Fluarix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| FluNG Group | Fluarix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4071/21893 (18.6%) | 4066/21802 (18.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 48/21893 (0.2%) | 64/21802 (0.3%) | ||
| Iron deficiency anaemia | 7/21893 (0%) | 14/21802 (0.1%) | ||
| Haemorrhagic anaemia | 4/21893 (0%) | 3/21802 (0%) | ||
| Thrombocytopenia | 4/21893 (0%) | 2/21802 (0%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 211/21893 (1%) | 178/21802 (0.8%) | ||
| Myocardial infarction | 169/21893 (0.8%) | 167/21802 (0.8%) | ||
| Cardiac failure congestive | 147/21893 (0.7%) | 153/21802 (0.7%) | ||
| Cardiac failure | 98/21893 (0.4%) | 102/21802 (0.5%) | ||
| Coronary artery disease | 90/21893 (0.4%) | 75/21802 (0.3%) | ||
| Angina pectoris | 77/21893 (0.4%) | 75/21802 (0.3%) | ||
| Myocardial ischaemia | 64/21893 (0.3%) | 62/21802 (0.3%) | ||
| Acute myocardial infarction | 38/21893 (0.2%) | 59/21802 (0.3%) | ||
| Arrhythmia | 35/21893 (0.2%) | 26/21802 (0.1%) | ||
| Cardiac arrest | 33/21893 (0.2%) | 28/21802 (0.1%) | ||
| Bradycardia | 18/21893 (0.1%) | 20/21802 (0.1%) | ||
| Angina unstable | 17/21893 (0.1%) | 18/21802 (0.1%) | ||
| Atrial flutter | 14/21893 (0.1%) | 16/21802 (0.1%) | ||
| Atrioventricular block | 11/21893 (0.1%) | 16/21802 (0.1%) | ||
| Acute coronary syndrome | 6/21893 (0%) | 18/21802 (0.1%) | ||
| Mitral valve incompetence | 14/21893 (0.1%) | 10/21802 (0%) | ||
| Aortic valve stenosis | 13/21893 (0.1%) | 8/21802 (0%) | ||
| Sick sinus syndrome | 10/21893 (0%) | 11/21802 (0.1%) | ||
| Atrioventricular block complete | 9/21893 (0%) | 11/21802 (0.1%) | ||
| Supraventricular tachycardia | 7/21893 (0%) | 13/21802 (0.1%) | ||
| Left ventricular failure | 9/21893 (0%) | 8/21802 (0%) | ||
| Tachyarrhythmia | 9/21893 (0%) | 8/21802 (0%) | ||
| Coronary artery stenosis | 7/21893 (0%) | 9/21802 (0%) | ||
| Arrhythmia supraventricular | 11/21893 (0.1%) | 4/21802 (0%) | ||
| Ventricular fibrillation | 8/21893 (0%) | 7/21802 (0%) | ||
| Cardiopulmonary failure | 7/21893 (0%) | 6/21802 (0%) | ||
| Arteriosclerosis coronary artery | 6/21893 (0%) | 6/21802 (0%) | ||
| Cardiac failure chronic | 7/21893 (0%) | 5/21802 (0%) | ||
| Cardio-respiratory arrest | 5/21893 (0%) | 7/21802 (0%) | ||
| Cardiovascular insufficiency | 6/21893 (0%) | 6/21802 (0%) | ||
| Coronary artery occlusion | 6/21893 (0%) | 6/21802 (0%) | ||
| Cardiac failure acute | 6/21893 (0%) | 5/21802 (0%) | ||
| Atrioventricular block second degree | 8/21893 (0%) | 2/21802 (0%) | ||
| Ventricular tachycardia | 4/21893 (0%) | 6/21802 (0%) | ||
| Aortic valve incompetence | 3/21893 (0%) | 6/21802 (0%) | ||
| Cardiogenic shock | 6/21893 (0%) | 2/21802 (0%) | ||
| Tachycardia | 3/21893 (0%) | 5/21802 (0%) | ||
| Ventricular extrasystoles | 4/21893 (0%) | 4/21802 (0%) | ||
| Coronary artery insufficiency | 2/21893 (0%) | 5/21802 (0%) | ||
| Hypertensive heart disease | 3/21893 (0%) | 4/21802 (0%) | ||
| Pericarditis | 2/21893 (0%) | 5/21802 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Gastrointestinal angiodysplasia | 3/21893 (0%) | 3/21802 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 14/21893 (0.1%) | 19/21802 (0.1%) | ||
| Vestibular disorder | 5/21893 (0%) | 8/21802 (0%) | ||
| Vertigo positional | 2/21893 (0%) | 8/21802 (0%) | ||
| Endocrine disorders | ||||
| Hypothyroidism | 4/21893 (0%) | 7/21802 (0%) | ||
| Hyperthyroidism | 1/21893 (0%) | 9/21802 (0%) | ||
| Goitre | 5/21893 (0%) | 3/21802 (0%) | ||
| Eye disorders | ||||
| Cataract | 16/21893 (0.1%) | 20/21802 (0.1%) | ||
| Glaucoma | 3/21893 (0%) | 8/21802 (0%) | ||
| Retinal detachment | 2/21893 (0%) | 6/21802 (0%) | ||
| Gastrointestinal disorders | ||||
| Inguinal hernia | 37/21893 (0.2%) | 26/21802 (0.1%) | ||
| Gastrointestinal haemorrhage | 19/21893 (0.1%) | 29/21802 (0.1%) | ||
| Gastritis | 20/21893 (0.1%) | 22/21802 (0.1%) | ||
| Pancreatitis acute | 18/21893 (0.1%) | 18/21802 (0.1%) | ||
| Gastric ulcer | 16/21893 (0.1%) | 18/21802 (0.1%) | ||
| Intestinal obstruction | 15/21893 (0.1%) | 19/21802 (0.1%) | ||
| Pancreatitis | 18/21893 (0.1%) | 11/21802 (0.1%) | ||
| Ileus | 14/21893 (0.1%) | 11/21802 (0.1%) | ||
| Small intestinal obstruction | 13/21893 (0.1%) | 12/21802 (0.1%) | ||
| Constipation | 11/21893 (0.1%) | 13/21802 (0.1%) | ||
| Duodenal ulcer | 15/21893 (0.1%) | 8/21802 (0%) | ||
| Peritonitis | 12/21893 (0.1%) | 11/21802 (0.1%) | ||
| Colitis | 8/21893 (0%) | 14/21802 (0.1%) | ||
| Abdominal pain | 13/21893 (0.1%) | 7/21802 (0%) | ||
| Colonic polyp | 11/21893 (0.1%) | 9/21802 (0%) | ||
| Upper gastrointestinal haemorrhage | 11/21893 (0.1%) | 9/21802 (0%) | ||
| Diarrhoea | 8/21893 (0%) | 9/21802 (0%) | ||
| Gastritis erosive | 9/21893 (0%) | 8/21802 (0%) | ||
| Gastrooesophageal reflux disease | 7/21893 (0%) | 10/21802 (0%) | ||
| Diverticulum | 7/21893 (0%) | 9/21802 (0%) | ||
| Gastric ulcer haemorrhage | 7/21893 (0%) | 9/21802 (0%) | ||
| Hiatus hernia | 5/21893 (0%) | 11/21802 (0.1%) | ||
| Colitis ischaemic | 3/21893 (0%) | 11/21802 (0.1%) | ||
| Large intestine perforation | 8/21893 (0%) | 5/21802 (0%) | ||
| Dyspepsia | 4/21893 (0%) | 8/21802 (0%) | ||
| Haemorrhoids | 7/21893 (0%) | 5/21802 (0%) | ||
| Rectal haemorrhage | 5/21893 (0%) | 7/21802 (0%) | ||
| Reflux oesophagitis | 3/21893 (0%) | 9/21802 (0%) | ||
| Dysphagia | 3/21893 (0%) | 7/21802 (0%) | ||
| Faecaloma | 4/21893 (0%) | 6/21802 (0%) | ||
| Lower gastrointestinal haemorrhage | 2/21893 (0%) | 8/21802 (0%) | ||
| Abdominal hernia | 6/21893 (0%) | 3/21802 (0%) | ||
| Oesophagitis | 5/21893 (0%) | 4/21802 (0%) | ||
| Pancreatitis chronic | 6/21893 (0%) | 3/21802 (0%) | ||
| Umbilical hernia | 4/21893 (0%) | 5/21802 (0%) | ||
| Diverticular perforation | 2/21893 (0%) | 6/21802 (0%) | ||
| Diverticulum intestinal | 6/21893 (0%) | 2/21802 (0%) | ||
| Peptic ulcer | 5/21893 (0%) | 3/21802 (0%) | ||
| Vomiting | 5/21893 (0%) | 3/21802 (0%) | ||
| Duodenitis | 3/21893 (0%) | 4/21802 (0%) | ||
| Gastric haemorrhage | 5/21893 (0%) | 2/21802 (0%) | ||
| Nausea | 5/21893 (0%) | 2/21802 (0%) | ||
| Oesophageal stenosis | 3/21893 (0%) | 4/21802 (0%) | ||
| Gastroduodenal ulcer | 4/21893 (0%) | 2/21802 (0%) | ||
| Haematochezia | 2/21893 (0%) | 4/21802 (0%) | ||
| Ileus paralytic | 5/21893 (0%) | 1/21802 (0%) | ||
| Intestinal polyp | 5/21893 (0%) | 1/21802 (0%) | ||
| Oesophageal varices haemorrhage | 2/21893 (0%) | 4/21802 (0%) | ||
| General disorders | ||||
| Chest pain | 42/21893 (0.2%) | 45/21802 (0.2%) | ||
| Death | 28/21893 (0.1%) | 27/21802 (0.1%) | ||
| Sudden death | 34/21893 (0.2%) | 18/21802 (0.1%) | ||
| Multi-organ failure | 9/21893 (0%) | 15/21802 (0.1%) | ||
| Cardiac death | 11/21893 (0.1%) | 8/21802 (0%) | ||
| Sudden cardiac death | 12/21893 (0.1%) | 7/21802 (0%) | ||
| Non-cardiac chest pain | 9/21893 (0%) | 8/21802 (0%) | ||
| Asthenia | 5/21893 (0%) | 3/21802 (0%) | ||
| Pyrexia | 3/21893 (0%) | 5/21802 (0%) | ||
| Device dislocation | 2/21893 (0%) | 5/21802 (0%) | ||
| Oedema peripheral | 4/21893 (0%) | 3/21802 (0%) | ||
| Pain | 2/21893 (0%) | 4/21802 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 44/21893 (0.2%) | 45/21802 (0.2%) | ||
| Cholecystitis | 40/21893 (0.2%) | 43/21802 (0.2%) | ||
| Cholecystitis acute | 23/21893 (0.1%) | 17/21802 (0.1%) | ||
| Bile duct stone | 15/21893 (0.1%) | 9/21802 (0%) | ||
| Hepatic cirrhosis | 11/21893 (0.1%) | 9/21802 (0%) | ||
| Cholangitis | 5/21893 (0%) | 5/21802 (0%) | ||
| Biliary colic | 3/21893 (0%) | 3/21802 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 7/21893 (0%) | 5/21802 (0%) | ||
| Anaphylactic reaction | 4/21893 (0%) | 3/21802 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 228/21893 (1%) | 226/21802 (1%) | ||
| Urinary tract infection | 129/21893 (0.6%) | 111/21802 (0.5%) | ||
| Sepsis | 41/21893 (0.2%) | 45/21802 (0.2%) | ||
| Gastroenteritis | 35/21893 (0.2%) | 47/21802 (0.2%) | ||
| Diverticulitis | 31/21893 (0.1%) | 34/21802 (0.2%) | ||
| Cellulitis | 29/21893 (0.1%) | 27/21802 (0.1%) | ||
| Bronchopneumonia | 26/21893 (0.1%) | 29/21802 (0.1%) | ||
| Erysipelas | 28/21893 (0.1%) | 21/21802 (0.1%) | ||
| Lobar pneumonia | 16/21893 (0.1%) | 19/21802 (0.1%) | ||
| Pyelonephritis | 21/21893 (0.1%) | 13/21802 (0.1%) | ||
| Appendicitis | 15/21893 (0.1%) | 17/21802 (0.1%) | ||
| Upper respiratory tract infection | 13/21893 (0.1%) | 17/21802 (0.1%) | ||
| Septic shock | 6/21893 (0%) | 18/21802 (0.1%) | ||
| Gangrene | 10/21893 (0%) | 11/21802 (0.1%) | ||
| Cystitis | 5/21893 (0%) | 12/21802 (0.1%) | ||
| Herpes zoster | 7/21893 (0%) | 9/21802 (0%) | ||
| Respiratory tract infection | 7/21893 (0%) | 9/21802 (0%) | ||
| Wound infection | 8/21893 (0%) | 7/21802 (0%) | ||
| Staphylococcal infection | 8/21893 (0%) | 5/21802 (0%) | ||
| Urosepsis | 8/21893 (0%) | 4/21802 (0%) | ||
| Sinusitis | 3/21893 (0%) | 7/21802 (0%) | ||
| Osteomyelitis | 2/21893 (0%) | 7/21802 (0%) | ||
| Clostridial infection | 2/21893 (0%) | 6/21802 (0%) | ||
| Clostridium difficile colitis | 5/21893 (0%) | 3/21802 (0%) | ||
| Infection | 2/21893 (0%) | 6/21802 (0%) | ||
| Candidiasis | 5/21893 (0%) | 2/21802 (0%) | ||
| Cholecystitis infective | 4/21893 (0%) | 3/21802 (0%) | ||
| Gastroenteritis norovirus | 3/21893 (0%) | 4/21802 (0%) | ||
| Gastroenteritis viral | 3/21893 (0%) | 4/21802 (0%) | ||
| Escherichia urinary tract infection | 6/21893 (0%) | 0/21802 (0%) | ||
| Infected skin ulcer | 2/21893 (0%) | 4/21802 (0%) | ||
| Infective exacerbation of chronic obstructive airways diseas | 3/21893 (0%) | 3/21802 (0%) | ||
| Localised infection | 3/21893 (0%) | 3/21802 (0%) | ||
| Lower respiratory tract infection | 2/21893 (0%) | 4/21802 (0%) | ||
| Lung infection | 1/21893 (0%) | 5/21802 (0%) | ||
| Pharyngitis | 2/21893 (0%) | 4/21802 (0%) | ||
| Postoperative wound infection | 2/21893 (0%) | 4/21802 (0%) | ||
| Pyelonephritis acute | 4/21893 (0%) | 2/21802 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Femoral neck fracture | 35/21893 (0.2%) | 53/21802 (0.2%) | ||
| Femur fracture | 34/21893 (0.2%) | 45/21802 (0.2%) | ||
| Hip fracture | 23/21893 (0.1%) | 34/21802 (0.2%) | ||
| Humerus fracture | 19/21893 (0.1%) | 35/21802 (0.2%) | ||
| Rib fracture | 21/21893 (0.1%) | 14/21802 (0.1%) | ||
| Toxicity to various agents | 17/21893 (0.1%) | 18/21802 (0.1%) | ||
| Radius fracture | 13/21893 (0.1%) | 20/21802 (0.1%) | ||
| Contusion | 20/21893 (0.1%) | 12/21802 (0.1%) | ||
| Ankle fracture | 14/21893 (0.1%) | 15/21802 (0.1%) | ||
| Concussion | 10/21893 (0%) | 16/21802 (0.1%) | ||
| Upper limb fracture | 9/21893 (0%) | 17/21802 (0.1%) | ||
| Spinal compression fracture | 14/21893 (0.1%) | 11/21802 (0.1%) | ||
| Wrist fracture | 15/21893 (0.1%) | 10/21802 (0%) | ||
| Pelvic fracture | 9/21893 (0%) | 11/21802 (0.1%) | ||
| Subdural haematoma | 5/21893 (0%) | 15/21802 (0.1%) | ||
| Lumbar vertebral fracture | 9/21893 (0%) | 10/21802 (0%) | ||
| Road traffic accident | 9/21893 (0%) | 9/21802 (0%) | ||
| Facial bones fracture | 9/21893 (0%) | 8/21802 (0%) | ||
| Head injury | 9/21893 (0%) | 8/21802 (0%) | ||
| Joint dislocation | 5/21893 (0%) | 11/21802 (0.1%) | ||
| Spinal fracture | 6/21893 (0%) | 9/21802 (0%) | ||
| Laceration | 8/21893 (0%) | 6/21802 (0%) | ||
| Lower limb fracture | 8/21893 (0%) | 6/21802 (0%) | ||
| Fall | 4/21893 (0%) | 9/21802 (0%) | ||
| Tendon rupture | 10/21893 (0%) | 3/21802 (0%) | ||
| Fibula fracture | 7/21893 (0%) | 4/21802 (0%) | ||
| Tibia fracture | 3/21893 (0%) | 8/21802 (0%) | ||
| Traumatic brain injury | 5/21893 (0%) | 5/21802 (0%) | ||
| Cervical vertebral fracture | 5/21893 (0%) | 4/21802 (0%) | ||
| Hand fracture | 4/21893 (0%) | 5/21802 (0%) | ||
| Meniscus lesion | 1/21893 (0%) | 8/21802 (0%) | ||
| Foot fracture | 5/21893 (0%) | 3/21802 (0%) | ||
| Forearm fracture | 7/21893 (0%) | 1/21802 (0%) | ||
| Brain contusion | 2/21893 (0%) | 5/21802 (0%) | ||
| Multiple injuries | 3/21893 (0%) | 4/21802 (0%) | ||
| Overdose | 3/21893 (0%) | 4/21802 (0%) | ||
| Pubis fracture | 1/21893 (0%) | 6/21802 (0%) | ||
| Thoracic vertebral fracture | 3/21893 (0%) | 4/21802 (0%) | ||
| Ulna fracture | 3/21893 (0%) | 4/21802 (0%) | ||
| Injury | 3/21893 (0%) | 3/21802 (0%) | ||
| Multiple fractures | 2/21893 (0%) | 4/21802 (0%) | ||
| Post procedural haemorrhage | 1/21893 (0%) | 5/21802 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 24/21893 (0.1%) | 25/21802 (0.1%) | ||
| Diabetes mellitus inadequate control | 22/21893 (0.1%) | 20/21802 (0.1%) | ||
| Hypoglycaemia | 23/21893 (0.1%) | 18/21802 (0.1%) | ||
| Diabetes mellitus | 18/21893 (0.1%) | 18/21802 (0.1%) | ||
| Type 2 diabetes mellitus | 16/21893 (0.1%) | 12/21802 (0.1%) | ||
| Hyponatraemia | 9/21893 (0%) | 11/21802 (0.1%) | ||
| Hypokalaemia | 8/21893 (0%) | 9/21802 (0%) | ||
| Diabetic foot | 5/21893 (0%) | 7/21802 (0%) | ||
| Hyperkalaemia | 3/21893 (0%) | 5/21802 (0%) | ||
| Hypercholesterolaemia | 3/21893 (0%) | 4/21802 (0%) | ||
| Hyperglycaemia | 5/21893 (0%) | 2/21802 (0%) | ||
| Cachexia | 3/21893 (0%) | 3/21802 (0%) | ||
| Electrolyte imbalance | 3/21893 (0%) | 3/21802 (0%) | ||
| Gout | 6/21893 (0%) | 0/21802 (0%) | ||
| Hypomagnesaemia | 1/21893 (0%) | 5/21802 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 87/21893 (0.4%) | 108/21802 (0.5%) | ||
| Intervertebral disc protrusion | 18/21893 (0.1%) | 26/21802 (0.1%) | ||
| Back pain | 15/21893 (0.1%) | 20/21802 (0.1%) | ||
| Spinal column stenosis | 19/21893 (0.1%) | 14/21802 (0.1%) | ||
| Rotator cuff syndrome | 8/21893 (0%) | 12/21802 (0.1%) | ||
| Arthralgia | 6/21893 (0%) | 12/21802 (0.1%) | ||
| Polymyalgia rheumatica | 12/21893 (0.1%) | 5/21802 (0%) | ||
| Intervertebral disc degeneration | 6/21893 (0%) | 10/21802 (0%) | ||
| Lumbar spinal stenosis | 7/21893 (0%) | 9/21802 (0%) | ||
| Rheumatoid arthritis | 8/21893 (0%) | 8/21802 (0%) | ||
| Spinal osteoarthritis | 8/21893 (0%) | 8/21802 (0%) | ||
| Arthritis | 5/21893 (0%) | 4/21802 (0%) | ||
| Bone pain | 5/21893 (0%) | 2/21802 (0%) | ||
| Osteonecrosis | 4/21893 (0%) | 3/21802 (0%) | ||
| Foot deformity | 2/21893 (0%) | 4/21802 (0%) | ||
| Intervertebral disc disorder | 4/21893 (0%) | 2/21802 (0%) | ||
| Musculoskeletal pain | 6/21893 (0%) | 0/21802 (0%) | ||
| Pain in extremity | 4/21893 (0%) | 2/21802 (0%) | ||
| Spondylolisthesis | 2/21893 (0%) | 4/21802 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Prostate cancer | 57/21893 (0.3%) | 60/21802 (0.3%) | ||
| Breast cancer | 48/21893 (0.2%) | 46/21802 (0.2%) | ||
| Colon cancer | 44/21893 (0.2%) | 35/21802 (0.2%) | ||
| Lung neoplasm malignant | 24/21893 (0.1%) | 38/21802 (0.2%) | ||
| Bladder cancer | 20/21893 (0.1%) | 19/21802 (0.1%) | ||
| Basal cell carcinoma | 12/21893 (0.1%) | 21/21802 (0.1%) | ||
| Gastric cancer | 15/21893 (0.1%) | 13/21802 (0.1%) | ||
| Pancreatic carcinoma | 15/21893 (0.1%) | 12/21802 (0.1%) | ||
| Rectal cancer | 10/21893 (0%) | 13/21802 (0.1%) | ||
| Bladder neoplasm | 13/21893 (0.1%) | 9/21802 (0%) | ||
| Squamous cell carcinoma | 8/21893 (0%) | 9/21802 (0%) | ||
| Malignant melanoma | 9/21893 (0%) | 7/21802 (0%) | ||
| Renal cancer | 10/21893 (0%) | 6/21802 (0%) | ||
| Hepatic neoplasm malignant | 8/21893 (0%) | 7/21802 (0%) | ||
| Pancreatic carcinoma metastatic | 7/21893 (0%) | 8/21802 (0%) | ||
| Lung adenocarcinoma | 7/21893 (0%) | 7/21802 (0%) | ||
| Neoplasm malignant | 9/21893 (0%) | 5/21802 (0%) | ||
| Lymphoma | 9/21893 (0%) | 4/21802 (0%) | ||
| Thyroid cancer | 8/21893 (0%) | 5/21802 (0%) | ||
| Metastases to liver | 6/21893 (0%) | 6/21802 (0%) | ||
| Prostatic adenoma | 7/21893 (0%) | 5/21802 (0%) | ||
| Colon cancer metastatic | 6/21893 (0%) | 5/21802 (0%) | ||
| Brain neoplasm | 5/21893 (0%) | 5/21802 (0%) | ||
| Lung neoplasm | 4/21893 (0%) | 6/21802 (0%) | ||
| Transitional cell carcinoma | 6/21893 (0%) | 4/21802 (0%) | ||
| Uterine cancer | 6/21893 (0%) | 4/21802 (0%) | ||
| Bronchial carcinoma | 4/21893 (0%) | 5/21802 (0%) | ||
| Non-hodgkin's lymphoma | 6/21893 (0%) | 3/21802 (0%) | ||
| Breast cancer metastatic | 4/21893 (0%) | 4/21802 (0%) | ||
| Chronic lymphocytic leukaemia | 3/21893 (0%) | 5/21802 (0%) | ||
| Colon neoplasm | 3/21893 (0%) | 5/21802 (0%) | ||
| Lung cancer metastatic | 4/21893 (0%) | 4/21802 (0%) | ||
| Oesophageal carcinoma | 5/21893 (0%) | 3/21802 (0%) | ||
| Renal neoplasm | 6/21893 (0%) | 2/21802 (0%) | ||
| Acute myeloid leukaemia | 2/21893 (0%) | 5/21802 (0%) | ||
| Adenocarcinoma | 4/21893 (0%) | 3/21802 (0%) | ||
| Colon adenoma | 2/21893 (0%) | 5/21802 (0%) | ||
| Endometrial cancer | 4/21893 (0%) | 3/21802 (0%) | ||
| Hepatic neoplasm | 5/21893 (0%) | 2/21802 (0%) | ||
| Metastatic malignant melanoma | 4/21893 (0%) | 3/21802 (0%) | ||
| Metastatic neoplasm | 3/21893 (0%) | 4/21802 (0%) | ||
| Multiple myeloma | 3/21893 (0%) | 4/21802 (0%) | ||
| Prostate cancer metastatic | 1/21893 (0%) | 6/21802 (0%) | ||
| Renal cancer metastatic | 1/21893 (0%) | 6/21802 (0%) | ||
| Breast cancer recurrent | 4/21893 (0%) | 2/21802 (0%) | ||
| Meningioma | 2/21893 (0%) | 4/21802 (0%) | ||
| Metastases to lung | 1/21893 (0%) | 5/21802 (0%) | ||
| Ovarian neoplasm | 3/21893 (0%) | 3/21802 (0%) | ||
| Renal cell carcinoma | 1/21893 (0%) | 5/21802 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 196/21893 (0.9%) | 180/21802 (0.8%) | ||
| Transient ischaemic attack | 69/21893 (0.3%) | 57/21802 (0.3%) | ||
| Syncope | 54/21893 (0.2%) | 43/21802 (0.2%) | ||
| Cerebrovascular disorder | 24/21893 (0.1%) | 21/21802 (0.1%) | ||
| Ischaemic stroke | 17/21893 (0.1%) | 28/21802 (0.1%) | ||
| Cerebral infarction | 23/21893 (0.1%) | 11/21802 (0.1%) | ||
| Epilepsy | 14/21893 (0.1%) | 11/21802 (0.1%) | ||
| Carotid artery stenosis | 13/21893 (0.1%) | 10/21802 (0%) | ||
| Vascular dementia | 12/21893 (0.1%) | 7/21802 (0%) | ||
| Cerebral ischaemia | 9/21893 (0%) | 9/21802 (0%) | ||
| Cerebral haemorrhage | 9/21893 (0%) | 4/21802 (0%) | ||
| Dementia | 4/21893 (0%) | 9/21802 (0%) | ||
| Dementia alzheimer's type | 9/21893 (0%) | 4/21802 (0%) | ||
| Dizziness | 5/21893 (0%) | 8/21802 (0%) | ||
| Parkinson's disease | 8/21893 (0%) | 5/21802 (0%) | ||
| Presyncope | 9/21893 (0%) | 4/21802 (0%) | ||
| Grand mal convulsion | 4/21893 (0%) | 8/21802 (0%) | ||
| Sciatica | 7/21893 (0%) | 5/21802 (0%) | ||
| Cerebral arteriosclerosis | 7/21893 (0%) | 4/21802 (0%) | ||
| Subarachnoid haemorrhage | 7/21893 (0%) | 4/21802 (0%) | ||
| Brain oedema | 3/21893 (0%) | 7/21802 (0%) | ||
| Haemorrhagic stroke | 5/21893 (0%) | 4/21802 (0%) | ||
| Vertebrobasilar insufficiency | 4/21893 (0%) | 5/21802 (0%) | ||
| Convulsion | 3/21893 (0%) | 5/21802 (0%) | ||
| Encephalopathy | 6/21893 (0%) | 2/21802 (0%) | ||
| Parkinsonism | 6/21893 (0%) | 1/21802 (0%) | ||
| Brain stem infarction | 3/21893 (0%) | 3/21802 (0%) | ||
| Embolic stroke | 3/21893 (0%) | 3/21802 (0%) | ||
| Vascular encephalopathy | 2/21893 (0%) | 4/21802 (0%) | ||
| Psychiatric disorders | ||||
| Depression | 24/21893 (0.1%) | 20/21802 (0.1%) | ||
| Completed suicide | 5/21893 (0%) | 7/21802 (0%) | ||
| Delirium | 6/21893 (0%) | 4/21802 (0%) | ||
| Confusional state | 4/21893 (0%) | 4/21802 (0%) | ||
| Renal and urinary disorders | ||||
| Renal failure acute | 60/21893 (0.3%) | 45/21802 (0.2%) | ||
| Renal failure chronic | 27/21893 (0.1%) | 30/21802 (0.1%) | ||
| Renal failure | 26/21893 (0.1%) | 27/21802 (0.1%) | ||
| Nephrolithiasis | 14/21893 (0.1%) | 20/21802 (0.1%) | ||
| Urinary retention | 13/21893 (0.1%) | 15/21802 (0.1%) | ||
| Haematuria | 8/21893 (0%) | 8/21802 (0%) | ||
| Calculus ureteric | 10/21893 (0%) | 4/21802 (0%) | ||
| Urethral stenosis | 3/21893 (0%) | 10/21802 (0%) | ||
| Calculus bladder | 6/21893 (0%) | 5/21802 (0%) | ||
| Hydronephrosis | 8/21893 (0%) | 3/21802 (0%) | ||
| Urinary bladder polyp | 3/21893 (0%) | 6/21802 (0%) | ||
| Calculus urinary | 2/21893 (0%) | 6/21802 (0%) | ||
| Cystitis haemorrhagic | 5/21893 (0%) | 3/21802 (0%) | ||
| Bladder neck obstruction | 1/21893 (0%) | 5/21802 (0%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 27/21893 (0.1%) | 31/21802 (0.1%) | ||
| Uterine prolapse | 7/21893 (0%) | 3/21802 (0%) | ||
| Ovarian cyst | 4/21893 (0%) | 5/21802 (0%) | ||
| Prostatitis | 3/21893 (0%) | 4/21802 (0%) | ||
| Uterine polyp | 4/21893 (0%) | 3/21802 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 141/21893 (0.6%) | 128/21802 (0.6%) | ||
| Pulmonary embolism | 47/21893 (0.2%) | 61/21802 (0.3%) | ||
| Bronchitis | 61/21893 (0.3%) | 43/21802 (0.2%) | ||
| Respiratory failure | 32/21893 (0.1%) | 37/21802 (0.2%) | ||
| Asthma | 33/21893 (0.2%) | 17/21802 (0.1%) | ||
| Pulmonary oedema | 19/21893 (0.1%) | 24/21802 (0.1%) | ||
| Acute respiratory failure | 22/21893 (0.1%) | 15/21802 (0.1%) | ||
| Pleural effusion | 15/21893 (0.1%) | 19/21802 (0.1%) | ||
| Bronchitis chronic | 14/21893 (0.1%) | 14/21802 (0.1%) | ||
| Pneumonia aspiration | 10/21893 (0%) | 14/21802 (0.1%) | ||
| Dyspnoea | 13/21893 (0.1%) | 10/21802 (0%) | ||
| Epistaxis | 13/21893 (0.1%) | 9/21802 (0%) | ||
| Pneumothorax | 7/21893 (0%) | 4/21802 (0%) | ||
| Acute pulmonary oedema | 2/21893 (0%) | 8/21802 (0%) | ||
| Emphysema | 2/21893 (0%) | 7/21802 (0%) | ||
| Pleurisy | 6/21893 (0%) | 3/21802 (0%) | ||
| Pulmonary fibrosis | 2/21893 (0%) | 6/21802 (0%) | ||
| Sleep apnoea syndrome | 3/21893 (0%) | 5/21802 (0%) | ||
| Pulmonary hypertension | 4/21893 (0%) | 3/21802 (0%) | ||
| Bronchiectasis | 5/21893 (0%) | 1/21802 (0%) | ||
| Interstitial lung disease | 3/21893 (0%) | 3/21802 (0%) | ||
| Respiratory arrest | 3/21893 (0%) | 3/21802 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Decubitus ulcer | 6/21893 (0%) | 7/21802 (0%) | ||
| Skin ulcer | 5/21893 (0%) | 6/21802 (0%) | ||
| Angioedema | 4/21893 (0%) | 5/21802 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 82/21893 (0.4%) | 83/21802 (0.4%) | ||
| Arteriosclerosis | 22/21893 (0.1%) | 30/21802 (0.1%) | ||
| Hypertensive crisis | 26/21893 (0.1%) | 21/21802 (0.1%) | ||
| Circulatory collapse | 23/21893 (0.1%) | 18/21802 (0.1%) | ||
| Deep vein thrombosis | 13/21893 (0.1%) | 24/21802 (0.1%) | ||
| Peripheral arterial occlusive disease | 19/21893 (0.1%) | 13/21802 (0.1%) | ||
| Aortic aneurysm | 13/21893 (0.1%) | 15/21802 (0.1%) | ||
| Hypotension | 14/21893 (0.1%) | 13/21802 (0.1%) | ||
| Haematoma | 15/21893 (0.1%) | 8/21802 (0%) | ||
| Peripheral vascular disorder | 11/21893 (0.1%) | 11/21802 (0.1%) | ||
| Aortic stenosis | 11/21893 (0.1%) | 7/21802 (0%) | ||
| Venous thrombosis | 9/21893 (0%) | 8/21802 (0%) | ||
| Thrombophlebitis | 7/21893 (0%) | 5/21802 (0%) | ||
| Thrombosis | 4/21893 (0%) | 8/21802 (0%) | ||
| Orthostatic hypotension | 5/21893 (0%) | 6/21802 (0%) | ||
| Arterial occlusive disease | 4/21893 (0%) | 6/21802 (0%) | ||
| Intermittent claudication | 4/21893 (0%) | 6/21802 (0%) | ||
| Peripheral ischaemia | 5/21893 (0%) | 4/21802 (0%) | ||
| Arterial thrombosis limb | 4/21893 (0%) | 4/21802 (0%) | ||
| Hypovolaemic shock | 5/21893 (0%) | 2/21802 (0%) | ||
| Varicose vein | 6/21893 (0%) | 1/21802 (0%) | ||
| Venous thrombosis limb | 3/21893 (0%) | 3/21802 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| FluNG Group | Fluarix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1999/3015 (66.3%) | 1360/3002 (45.3%) | ||
| General disorders | ||||
| Pain | 1225/3015 (40.6%) | 477/3002 (15.9%) | ||
| Redness | 240/3015 (8%) | 66/3002 (2.2%) | ||
| Swelling | 189/3015 (6.3%) | 40/3002 (1.3%) | ||
| Pain | 998/3015 (33.1%) | 440/3002 (14.7%) | ||
| Redness | 212/3015 (7%) | 54/3002 (1.8%) | ||
| Swelling | 173/3015 (5.7%) | 38/3002 (1.3%) | ||
| Arthralgia | 391/3015 (13%) | 239/3002 (8%) | ||
| Fatigue | 646/3015 (21.4%) | 417/3002 (13.9%) | ||
| Gastrointestinal | 197/3015 (6.5%) | 165/3002 (5.5%) | ||
| Headache | 474/3015 (15.7%) | 333/3002 (11.1%) | ||
| Myalgia | 547/3015 (18.1%) | 302/3002 (10.1%) | ||
| Shivering | 245/3015 (8.1%) | 80/3002 (2.7%) | ||
| Arthralgia | 258/3015 (8.6%) | 176/3002 (5.9%) | ||
| Fatigue | 457/3015 (15.2%) | 318/3002 (10.6%) | ||
| Gastrointestinal | 137/3015 (4.5%) | 124/3002 (4.1%) | ||
| Headache | 342/3015 (11.3%) | 237/3002 (7.9%) | ||
| Myalgia | 380/3015 (12.6%) | 209/3002 (7%) | ||
| Shivering | 189/3015 (6.3%) | 88/3002 (2.9%) | ||
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:
NCT00753272
Other Study ID Numbers:
- 106372
First Posted:
Sep 16, 2008
Last Update Posted:
Jun 8, 2018
Last Verified:
Aug 1, 2017