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Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

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ClinicalTrials.gov Identifier: NCT00753272
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : June 19, 2012
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: GSK Bio's influenza vaccine GSK2186877A
Biological: Fluarix TM
Enrollment 43695
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 Details 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
Hide 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
Reason Not Completed
Adverse Event             878             869
Protocol Violation             28             46
Withdrawal by Subject             2481             2407
Lost to Follow-up             491             497
Other             1104             1088
Arm/Group Title FluNG Group Fluarix Group Total
Hide 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 Number of Baseline Participants 21893 21802 43695
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21893 participants 21802 participants 43695 participants
73.5  (6.09) 73.5  (6.16) 73.5  (6.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21893 participants 21802 participants 43695 participants
Female
12549
  57.3%
12422
  57.0%
24971
  57.1%
Male
9344
  42.7%
9380
  43.0%
18724
  42.9%
1.Primary Outcome
Title Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
Hide 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))
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21573 21482
Measure Type: Count of Participants
Unit of Measure: Participants
274
   1.3%
310
   1.4%
2.Primary Outcome
Title Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 540 538 534
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane [Day 0] Number Analyzed 539 participants 536 participants 532 participants
15.9
(14.6 to 17.3)
15.8
(14.5 to 17.2)
15.8
(14.5 to 17.2)
A/Brisbane [Day 21] Number Analyzed 540 participants 538 participants 534 participants
82.3
(75.0 to 90.2)
83.6
(76.0 to 92.0)
93.4
(84.6 to 103.1)
A/Uruguay [Day 0] Number Analyzed 539 participants 536 participants 532 participants
18.2
(16.5 to 20.2)
17.8
(16.0 to 19.9)
17.3
(15.6 to 19.2)
A/Uruguay [Day 21] Number Analyzed 540 participants 538 participants 534 participants
272.5
(243.0 to 305.6)
287.5
(256.2 to 322.7)
269.9
(239.9 to 303.6)
B/Brisbane[Day 0] Number Analyzed 539 participants 536 participants 532 participants
94.2
(84.8 to 104.7)
89.9
(80.6 to 100.3)
87.1
(78.3 to 96.7)
B/Brisbane[Day 21] Number Analyzed 540 participants 538 participants 534 participants
652.4
(602.0 to 707.1)
596.9
(552.2 to 645.3)
601.7
(555.0 to 652.4)
3.Secondary Outcome
Title Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 20579 20458
Measure Type: Count of Participants
Unit of Measure: Participants
262
   1.3%
296
   1.4%
4.Secondary Outcome
Title Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 20579 20458
Measure Type: Count of Participants
Unit of Measure: Participants
144
   0.7%
145
   0.7%
5.Secondary Outcome
Title Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21394 21337
Measure Type: Count of Participants
Unit of Measure: Participants
202
   0.9%
225
   1.1%
6.Secondary Outcome
Title Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21394 21337
Measure Type: Count of Participants
Unit of Measure: Participants
63
   0.3%
88
   0.4%
7.Secondary Outcome
Title Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21394 21337
Measure Type: Count of Participants
Unit of Measure: Participants
84
   0.4%
89
   0.4%
8.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21893 21802
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
70
   0.3%
60
   0.3%
Grade 3 AEs
13
   0.1%
8
   0.0%
Related AEs
11
   0.1%
7
   0.0%
9.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 17070 17071
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
35
   0.2%
40
   0.2%
Grade 3 AEs
9
   0.1%
6
   0.0%
Related AEs
2
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title FluNG Group Fluarix Group
Hide 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).
Overall Number of Participants Analyzed 21893 21802
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
103
   0.5%
99
   0.5%
Grade 3 AEs
22
   0.1%
14
   0.1%
Related AEs
13
   0.1%
7
   0.0%
11.Secondary Outcome
Title Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title FluNG Group Fluarix Group
Hide 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).
Overall Number of Participants Analyzed 21893 21802
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
4071
  18.6%
4066
  18.6%
Related SAEs
9
   0.0%
6
   0.0%
12.Secondary Outcome
Title Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2988 2968
Measure Type: Count of Participants
Unit of Measure: Participants
Any ecchymosis
40
   1.3%
18
   0.6%
Ecchymosis > 100 mm
0
   0.0%
0
   0.0%
Any pain
1225
  41.0%
477
  16.1%
Grade 3 pain
4
   0.1%
3
   0.1%
Any redness
240
   8.0%
66
   2.2%
Redness > 100 mm
6
   0.2%
3
   0.1%
Any swelling
189
   6.3%
40
   1.3%
Swelling > 100 mm
4
   0.1%
0
   0.0%
13.Secondary Outcome
Title Number of Days With Any Grade of Solicited Local Symptoms
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 1221 476
Mean (Full Range)
Unit of Measure: Days
Ecchymosis Number Analyzed 39 participants 18 participants
3.6
(1.0 to 7.0)
4.0
(1.0 to 7.0)
Pain Number Analyzed 1221 participants 476 participants
2.5
(1.0 to 7.0)
2.1
(1.0 to 7.0)
Redness Number Analyzed 237 participants 63 participants
2.9
(1.0 to 7.0)
2.5
(1.0 to 7.0)
Swelling Number Analyzed 186 participants 40 participants
2.9
(1.0 to 7.0)
2.0
(1.0 to 7.0)
14.Secondary Outcome
Title Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2441 2488
Measure Type: Count of Participants
Unit of Measure: Participants
Any ecchymosis
39
   1.6%
31
   1.2%
Ecchymosis > 100 mm
1
   0.0%
0
   0.0%
Any pain
998
  40.9%
440
  17.7%
Grade 3 pain
13
   0.5%
7
   0.3%
Any redness
212
   8.7%
54
   2.2%
Redness > 100 mm
4
   0.2%
2
   0.1%
Any swelling
173
   7.1%
38
   1.5%
Swelling > 100 mm
3
   0.1%
0
   0.0%
15.Secondary Outcome
Title Number of Days With Any Grade of Solicited Local Symptoms.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 995 431
Mean (Full Range)
Unit of Measure: Days
Ecchymosis Number Analyzed 28 participants 22 participants
2.8
(1.0 to 7.0)
3.6
(1.0 to 7.0)
Pain Number Analyzed 995 participants 431 participants
2.5
(1.0 to 7.0)
2.0
(1.0 to 7.0)
Redness Number Analyzed 202 participants 46 participants
2.8
(1.0 to 7.0)
2.6
(1.0 to 7.0)
Swelling Number Analyzed 162 participants 25 participants
2.5
(1.0 to 7.0)
2.7
(1.0 to 7.0)
16.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2986 2968
Measure Type: Count of Participants
Unit of Measure: Participants
Any arthralgia
391
  13.1%
239
   8.1%
Grade 3 arthralgia
11
   0.4%
5
   0.2%
Related arthralgia
285
   9.5%
163
   5.5%
Any fatigue
646
  21.6%
417
  14.0%
Grade 3 fatigue
20
   0.7%
15
   0.5%
Related fatigue
494
  16.5%
295
   9.9%
Any gastrointestinal
197
   6.6%
165
   5.6%
Grade 3 gastrointestinal
6
   0.2%
4
   0.1%
Related gastrointestinal
132
   4.4%
82
   2.8%
Any headache
474
  15.9%
333
  11.2%
Grade 3 headache
8
   0.3%
4
   0.1%
Related headache
341
  11.4%
213
   7.2%
Any myalgia
547
  18.3%
302
  10.2%
Grade 3 myalgia
14
   0.5%
11
   0.4%
Related myalgia
412
  13.8%
203
   6.8%
Any shivering
245
   8.2%
80
   2.7%
Grade 3 shivering
12
   0.4%
2
   0.1%
Related shivering
185
   6.2%
49
   1.7%
Temperature >= 38.0°C
72
   2.4%
20
   0.7%
Temperature >= 39.0°C - <=40.0°C
5
   0.2%
2
   0.1%
Related temperature
51
   1.7%
14
   0.5%
17.Secondary Outcome
Title Number of Days With Any Grade of Solicited General Symptoms
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 642 417
Mean (Full Range)
Unit of Measure: Days
Arthralgia Number Analyzed 388 participants 239 participants
2.8
(1.0 to 7.0)
2.9
(1.0 to 7.0)
Fatigue Number Analyzed 642 participants 417 participants
2.5
(1.0 to 7.0)
2.7
(1.0 to 7.0)
Gastrointestinal Number Analyzed 195 participants 164 participants
2.2
(1.0 to 7.0)
2.2
(1.0 to 7.0)
Headache Number Analyzed 472 participants 332 participants
2.2
(1.0 to 7.0)
2.3
(1.0 to 7.0)
Myalgia Number Analyzed 544 participants 301 participants
2.3
(1.0 to 7.0)
2.3
(1.0 to 7.0)
Shivering Number Analyzed 244 participants 80 participants
1.6
(1.0 to 7.0)
2.1
(1.0 to 7.0)
Temperature Number Analyzed 59 participants 16 participants
1.4
(1.0 to 7.0)
1.3
(1.0 to 4.0)
18.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2436 2489
Measure Type: Count of Participants
Unit of Measure: Participants
Any arthralgia
258
  10.6%
176
   7.1%
Grade 3 arthralgia
10
   0.4%
4
   0.2%
Related arthralgia
169
   6.9%
90
   3.6%
Any fatigue
457
  18.8%
318
  12.8%
Grade 3 fatigue
8
   0.3%
6
   0.2%
Related fatigue
307
  12.6%
169
   6.8%
Any gastrointestinal
137
   5.6%
124
   5.0%
Grade 3 gastrointestinal
5
   0.2%
8
   0.3%
Related gastrointestinal
71
   2.9%
46
   1.8%
Any headache
342
  14.0%
237
   9.5%
Grade 3 headache
10
   0.4%
4
   0.2%
Related headache
219
   9.0%
119
   4.8%
Any myalgia
380
  15.6%
209
   8.4%
Grade 3 myalgia
11
   0.5%
6
   0.2%
Related myalgia
261
  10.7%
117
   4.7%
Any shivering
189
   7.8%
88
   3.5%
Grade 3 shivering
11
   0.5%
6
   0.2%
Related shivering
127
   5.2%
44
   1.8%
Temperature >= 38.0°C
52
   2.1%
25
   1.0%
Temperature >= 39.0°C - <= 40.0°C
5
   0.2%
2
   0.1%
Related temperature
33
   1.4%
7
   0.3%
19.Secondary Outcome
Title Number of Days With Any Grade of Solicited General Symptoms.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 446 313
Mean (Full Range)
Unit of Measure: Days
Arthralgia Number Analyzed 247 participants 169 participants
2.7
(1.0 to 7.0)
3.0
(1.0 to 7.0)
Fatigue Number Analyzed 446 participants 313 participants
2.6
(1.0 to 7.0)
2.7
(1.0 to 7.0)
Gastrointestinal Number Analyzed 125 participants 115 participants
2.3
(1.0 to 7.0)
2.6
(1.0 to 7.0)
Headache Number Analyzed 331 participants 229 participants
2.2
(1.0 to 7.0)
2.4
(1.0 to 7.0)
Myalgia Number Analyzed 370 participants 200 participants
2.4
(1.0 to 7.0)
2.6
(1.0 to 7.0)
Shivering Number Analyzed 177 participants 80 participants
1.6
(1.0 to 7.0)
2.3
(1.0 to 7.0)
Temperature Number Analyzed 38 participants 13 participants
1.2
(1.0 to 4.0)
1.5
(1.0 to 4.0)
20.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 3015 3002
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
428
  14.2%
427
  14.2%
Grade 3 AEs
48
   1.6%
52
   1.7%
Related AEs
83
   2.8%
58
   1.9%
21.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2462 2520
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
320
  13.0%
306
  12.1%
Grade 3 AEs
36
   1.5%
26
   1.0%
Related AEs
42
   1.7%
20
   0.8%
22.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 3015 3002
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
1018
  33.8%
996
  33.2%
Grade 3 AEs
223
   7.4%
211
   7.0%
Related AEs
16
   0.5%
7
   0.2%
23.Secondary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2462 2520
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
849
  34.5%
864
  34.3%
Grade 3 AEs
158
   6.4%
154
   6.1%
Related AEs
7
   0.3%
5
   0.2%
24.Secondary Outcome
Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 2422 2408
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane [Day 0] Number Analyzed 2417 participants 2397 participants
15.5
(14.9 to 16.1)
15.3
(14.7 to 16.0)
A/Brisbane [Day 21] Number Analyzed 2422 participants 2408 participants
89.1
(85.2 to 93.2)
69.9
(66.5 to 73.4)
A/Uruguay [Day 0] Number Analyzed 2417 participants 2397 participants
17.4
(16.6 to 18.3)
17.4
(16.5 to 18.2)
A/Uruguay [Day 21] Number Analyzed 2422 participants 2408 participants
285.6
(270.6 to 301.4)
172.3
(162.7 to 182.5)
B/Brisbane [Day 0] Number Analyzed 2416 participants 2397 participants
85.3
(81.2 to 89.7)
82.4
(78.3 to 86.7)
B/Brisbane [Day 21] Number Analyzed 2422 participants 2408 participants
633.5
(609.9 to 658.0)
484.8
(465.1 to 505.4)
25.Secondary Outcome
Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 1938 1953
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane [Day 0] Number Analyzed 1932 participants 1942 participants
23.9
(22.9 to 25.0)
24.3
(23.2 to 25.5)
A/Brisbane [Day 21] Number Analyzed 1936 participants 1952 participants
76.9
(73.6 to 80.4)
70.5
(67.1 to 74.0)
A/Uruguay [Day 0] Number Analyzed 1932 participants 1942 participants
57.8
(54.5 to 61.3)
46.5
(43.9 to 49.4)
A/Uruguay [Day 21] Number Analyzed 1937 participants 1953 participants
256.8
(245.3 to 268.9)
162.0
(153.9 to 170.4)
B/Brisbane [Day 0] Number Analyzed 1933 participants 1942 participants
58.6
(55.6 to 61.8)
56.6
(53.6 to 59.7)
B/Brisbane [Day 21] Number Analyzed 1938 participants 1953 participants
199.2
(190.8 to 207.9)
171.3
(163.6 to 179.4)
26.Secondary Outcome
Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 268 267
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane [Day 0] Number Analyzed 268 participants 265 participants
15.4
(13.7 to 17.4)
13.9
(12.4 to 15.6)
A/Brisbane [Day 21] Number Analyzed 268 participants 267 participants
75.4
(66.3 to 85.9)
64.5
(55.7 to 74.7)
A/Brisbane [Day 180] Number Analyzed 268 participants 267 participants
30.4
(26.8 to 34.4)
28.1
(24.8 to 31.8)
A/Uruguay [Day 0] Number Analyzed 268 participants 265 participants
19.3
(16.5 to 22.6)
17.8
(15.3 to 20.7)
A/Uruguay [Day 21] Number Analyzed 268 participants 267 participants
275.0
(233.1 to 324.5)
165.0
(139.0 to 195.9)
A/Uruguay [Day 180] Number Analyzed 268 participants 267 participants
97.7
(82.3 to 116.0)
64.0
(53.7 to 76.3)
B/Brisbane [Day 0] Number Analyzed 268 participants 265 participants
89.3
(76.6 to 104.2)
83.8
(72.3 to 97.1)
B/Brisbane [Day 21] Number Analyzed 268 participants 267 participants
573.4
(517.5 to 635.3)
478.5
(422.4 to 541.9)
B/Brisbane [Day 180] Number Analyzed 268 participants 267 participants
274.6
(246.5 to 305.9)
262.3
(234.7 to 293.1)
27.Secondary Outcome
Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 189 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane [Day 0] Number Analyzed 188 participants 177 participants
23.4
(20.3 to 27.1)
25.0
(21.3 to 29.3)
A/Brisbane [Day 21] Number Analyzed 188 participants 176 participants
80.0
(69.4 to 92.2)
75.0
(63.4 to 88.6)
A/Brisbane [Day 180] Number Analyzed 189 participants 177 participants
28.5
(24.7 to 32.8)
27.3
(23.5 to 31.7)
A/Uruguay [Day 0] Number Analyzed 188 participants 177 participants
68.9
(56.2 to 84.5)
54.2
(44.1 to 66.5)
A/Uruguay [Day 21] Number Analyzed 188 participants 176 participants
300.6
(254.0 to 355.7)
195.6
(165.5 to 231.2)
A/Uruguay [Day 180] Number Analyzed 189 participants 177 participants
105.7
(87.9 to 127.2)
63.6
(53.0 to 76.3)
B/Brisbane [Day 0] Number Analyzed 189 participants 177 participants
58.5
(48.8 to 70.1)
56.1
(47.0 to 67.0)
B/Brisbane [Day 21] Number Analyzed 189 participants 176 participants
225.1
(195.5 to 259.1)
191.0
(161.3 to 226.3)
B/Brisbane [Day 180] Number Analyzed 189 participants 177 participants
122.9
(106.5 to 141.7)
111.6
(95.8 to 130.0)
28.Secondary Outcome
Title Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 539 536 532
Measure Type: Count of Participants
Unit of Measure: Participants
A/Brisbane
307
  57.0%
298
  55.6%
310
  58.3%
A/Uruguay
471
  87.4%
461
  86.0%
455
  85.5%
B/Brisbane
389
  72.2%
350
  65.3%
363
  68.2%
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 [Not Specified]
 
Arm/Group Title FluNG Group Fluarix Group
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FluNG Group Fluarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4071/21893 (18.59%)   4066/21802 (18.65%) 
Blood and lymphatic system disorders     
Anaemia *  48/21893 (0.22%)  64/21802 (0.29%) 
Iron deficiency anaemia *  7/21893 (0.03%)  14/21802 (0.06%) 
Haemorrhagic anaemia *  4/21893 (0.02%)  3/21802 (0.01%) 
Thrombocytopenia *  4/21893 (0.02%)  2/21802 (0.01%) 
Cardiac disorders     
Atrial fibrillation *  211/21893 (0.96%)  178/21802 (0.82%) 
Myocardial infarction *  169/21893 (0.77%)  167/21802 (0.77%) 
Cardiac failure congestive *  147/21893 (0.67%)  153/21802 (0.70%) 
Cardiac failure *  98/21893 (0.45%)  102/21802 (0.47%) 
Coronary artery disease *  90/21893 (0.41%)  75/21802 (0.34%) 
Angina pectoris *  77/21893 (0.35%)  75/21802 (0.34%) 
Myocardial ischaemia *  64/21893 (0.29%)  62/21802 (0.28%) 
Acute myocardial infarction *  38/21893 (0.17%)  59/21802 (0.27%) 
Arrhythmia *  35/21893 (0.16%)  26/21802 (0.12%) 
Cardiac arrest *  33/21893 (0.15%)  28/21802 (0.13%) 
Bradycardia *  18/21893 (0.08%)  20/21802 (0.09%) 
Angina unstable *  17/21893 (0.08%)  18/21802 (0.08%) 
Atrial flutter *  14/21893 (0.06%)  16/21802 (0.07%) 
Atrioventricular block *  11/21893 (0.05%)  16/21802 (0.07%) 
Acute coronary syndrome *  6/21893 (0.03%)  18/21802 (0.08%) 
Mitral valve incompetence *  14/21893 (0.06%)  10/21802 (0.05%) 
Aortic valve stenosis *  13/21893 (0.06%)  8/21802 (0.04%) 
Sick sinus syndrome *  10/21893 (0.05%)  11/21802 (0.05%) 
Atrioventricular block complete *  9/21893 (0.04%)  11/21802 (0.05%) 
Supraventricular tachycardia *  7/21893 (0.03%)  13/21802 (0.06%) 
Left ventricular failure *  9/21893 (0.04%)  8/21802 (0.04%) 
Tachyarrhythmia *  9/21893 (0.04%)  8/21802 (0.04%) 
Coronary artery stenosis *  7/21893 (0.03%)  9/21802 (0.04%) 
Arrhythmia supraventricular *  11/21893 (0.05%)  4/21802 (0.02%) 
Ventricular fibrillation *  8/21893 (0.04%)  7/21802 (0.03%) 
Cardiopulmonary failure *  7/21893 (0.03%)  6/21802 (0.03%) 
Arteriosclerosis coronary artery *  6/21893 (0.03%)  6/21802 (0.03%) 
Cardiac failure chronic *  7/21893 (0.03%)  5/21802 (0.02%) 
Cardio-respiratory arrest *  5/21893 (0.02%)  7/21802 (0.03%) 
Cardiovascular insufficiency *  6/21893 (0.03%)  6/21802 (0.03%) 
Coronary artery occlusion *  6/21893 (0.03%)  6/21802 (0.03%) 
Cardiac failure acute *  6/21893 (0.03%)  5/21802 (0.02%) 
Atrioventricular block second degree *  8/21893 (0.04%)  2/21802 (0.01%) 
Ventricular tachycardia *  4/21893 (0.02%)  6/21802 (0.03%) 
Aortic valve incompetence *  3/21893 (0.01%)  6/21802 (0.03%) 
Cardiogenic shock *  6/21893 (0.03%)  2/21802 (0.01%) 
Tachycardia *  3/21893 (0.01%)  5/21802 (0.02%) 
Ventricular extrasystoles *  4/21893 (0.02%)  4/21802 (0.02%) 
Coronary artery insufficiency *  2/21893 (0.01%)  5/21802 (0.02%) 
Hypertensive heart disease *  3/21893 (0.01%)  4/21802 (0.02%) 
Pericarditis *  2/21893 (0.01%)  5/21802 (0.02%) 
Congenital, familial and genetic disorders     
Gastrointestinal angiodysplasia *  3/21893 (0.01%)  3/21802 (0.01%) 
Ear and labyrinth disorders     
Vertigo *  14/21893 (0.06%)  19/21802 (0.09%) 
Vestibular disorder *  5/21893 (0.02%)  8/21802 (0.04%) 
Vertigo positional *  2/21893 (0.01%)  8/21802 (0.04%) 
Endocrine disorders     
Hypothyroidism *  4/21893 (0.02%)  7/21802 (0.03%) 
Hyperthyroidism *  1/21893 (0.00%)  9/21802 (0.04%) 
Goitre *  5/21893 (0.02%)  3/21802 (0.01%) 
Eye disorders     
Cataract *  16/21893 (0.07%)  20/21802 (0.09%) 
Glaucoma *  3/21893 (0.01%)  8/21802 (0.04%) 
Retinal detachment *  2/21893 (0.01%)  6/21802 (0.03%) 
Gastrointestinal disorders     
Inguinal hernia *  37/21893 (0.17%)  26/21802 (0.12%) 
Gastrointestinal haemorrhage *  19/21893 (0.09%)  29/21802 (0.13%) 
Gastritis *  20/21893 (0.09%)  22/21802 (0.10%) 
Pancreatitis acute *  18/21893 (0.08%)  18/21802 (0.08%) 
Gastric ulcer *  16/21893 (0.07%)  18/21802 (0.08%) 
Intestinal obstruction *  15/21893 (0.07%)  19/21802 (0.09%) 
Pancreatitis *  18/21893 (0.08%)  11/21802 (0.05%) 
Ileus *  14/21893 (0.06%)  11/21802 (0.05%) 
Small intestinal obstruction *  13/21893 (0.06%)  12/21802 (0.06%) 
Constipation *  11/21893 (0.05%)  13/21802 (0.06%) 
Duodenal ulcer *  15/21893 (0.07%)  8/21802 (0.04%) 
Peritonitis *  12/21893 (0.05%)  11/21802 (0.05%) 
Colitis *  8/21893 (0.04%)  14/21802 (0.06%) 
Abdominal pain *  13/21893 (0.06%)  7/21802 (0.03%) 
Colonic polyp *  11/21893 (0.05%)  9/21802 (0.04%) 
Upper gastrointestinal haemorrhage *  11/21893 (0.05%)  9/21802 (0.04%) 
Diarrhoea *  8/21893 (0.04%)  9/21802 (0.04%) 
Gastritis erosive *  9/21893 (0.04%)  8/21802 (0.04%) 
Gastrooesophageal reflux disease *  7/21893 (0.03%)  10/21802 (0.05%) 
Diverticulum *  7/21893 (0.03%)  9/21802 (0.04%) 
Gastric ulcer haemorrhage *  7/21893 (0.03%)  9/21802 (0.04%) 
Hiatus hernia *  5/21893 (0.02%)  11/21802 (0.05%) 
Colitis ischaemic *  3/21893 (0.01%)  11/21802 (0.05%) 
Large intestine perforation *  8/21893 (0.04%)  5/21802 (0.02%) 
Dyspepsia *  4/21893 (0.02%)  8/21802 (0.04%) 
Haemorrhoids *  7/21893 (0.03%)  5/21802 (0.02%) 
Rectal haemorrhage *  5/21893 (0.02%)  7/21802 (0.03%) 
Reflux oesophagitis *  3/21893 (0.01%)  9/21802 (0.04%) 
Dysphagia *  3/21893 (0.01%)  7/21802 (0.03%) 
Faecaloma *  4/21893 (0.02%)  6/21802 (0.03%) 
Lower gastrointestinal haemorrhage *  2/21893 (0.01%)  8/21802 (0.04%) 
Abdominal hernia *  6/21893 (0.03%)  3/21802 (0.01%) 
Oesophagitis *  5/21893 (0.02%)  4/21802 (0.02%) 
Pancreatitis chronic *  6/21893 (0.03%)  3/21802 (0.01%) 
Umbilical hernia *  4/21893 (0.02%)  5/21802 (0.02%) 
Diverticular perforation *  2/21893 (0.01%)  6/21802 (0.03%) 
Diverticulum intestinal *  6/21893 (0.03%)  2/21802 (0.01%) 
Peptic ulcer *  5/21893 (0.02%)  3/21802 (0.01%) 
Vomiting *  5/21893 (0.02%)  3/21802 (0.01%) 
Duodenitis *  3/21893 (0.01%)  4/21802 (0.02%) 
Gastric haemorrhage *  5/21893 (0.02%)  2/21802 (0.01%) 
Nausea *  5/21893 (0.02%)  2/21802 (0.01%) 
Oesophageal stenosis *  3/21893 (0.01%)  4/21802 (0.02%) 
Gastroduodenal ulcer *  4/21893 (0.02%)  2/21802 (0.01%) 
Haematochezia *  2/21893 (0.01%)  4/21802 (0.02%) 
Ileus paralytic *  5/21893 (0.02%)  1/21802 (0.00%) 
Intestinal polyp *  5/21893 (0.02%)  1/21802 (0.00%) 
Oesophageal varices haemorrhage *  2/21893 (0.01%)  4/21802 (0.02%) 
General disorders     
Chest pain *  42/21893 (0.19%)  45/21802 (0.21%) 
Death *  28/21893 (0.13%)  27/21802 (0.12%) 
Sudden death *  34/21893 (0.16%)  18/21802 (0.08%) 
Multi-organ failure *  9/21893 (0.04%)  15/21802 (0.07%) 
Cardiac death *  11/21893 (0.05%)  8/21802 (0.04%) 
Sudden cardiac death *  12/21893 (0.05%)  7/21802 (0.03%) 
Non-cardiac chest pain *  9/21893 (0.04%)  8/21802 (0.04%) 
Asthenia *  5/21893 (0.02%)  3/21802 (0.01%) 
Pyrexia *  3/21893 (0.01%)  5/21802 (0.02%) 
Device dislocation *  2/21893 (0.01%)  5/21802 (0.02%) 
Oedema peripheral *  4/21893 (0.02%)  3/21802 (0.01%) 
Pain *  2/21893 (0.01%)  4/21802 (0.02%) 
Hepatobiliary disorders     
Cholelithiasis *  44/21893 (0.20%)  45/21802 (0.21%) 
Cholecystitis *  40/21893 (0.18%)  43/21802 (0.20%) 
Cholecystitis acute *  23/21893 (0.11%)  17/21802 (0.08%) 
Bile duct stone *  15/21893 (0.07%)  9/21802 (0.04%) 
Hepatic cirrhosis *  11/21893 (0.05%)  9/21802 (0.04%) 
Cholangitis *  5/21893 (0.02%)  5/21802 (0.02%) 
Biliary colic *  3/21893 (0.01%)  3/21802 (0.01%) 
Immune system disorders     
Hypersensitivity *  7/21893 (0.03%)  5/21802 (0.02%) 
Anaphylactic reaction *  4/21893 (0.02%)  3/21802 (0.01%) 
Infections and infestations     
Pneumonia *  228/21893 (1.04%)  226/21802 (1.04%) 
Urinary tract infection *  129/21893 (0.59%)  111/21802 (0.51%) 
Sepsis *  41/21893 (0.19%)  45/21802 (0.21%) 
Gastroenteritis *  35/21893 (0.16%)  47/21802 (0.22%) 
Diverticulitis *  31/21893 (0.14%)  34/21802 (0.16%) 
Cellulitis *  29/21893 (0.13%)  27/21802 (0.12%) 
Bronchopneumonia *  26/21893 (0.12%)  29/21802 (0.13%) 
Erysipelas *  28/21893 (0.13%)  21/21802 (0.10%) 
Lobar pneumonia *  16/21893 (0.07%)  19/21802 (0.09%) 
Pyelonephritis *  21/21893 (0.10%)  13/21802 (0.06%) 
Appendicitis *  15/21893 (0.07%)  17/21802 (0.08%) 
Upper respiratory tract infection *  13/21893 (0.06%)  17/21802 (0.08%) 
Septic shock *  6/21893 (0.03%)  18/21802 (0.08%) 
Gangrene *  10/21893 (0.05%)  11/21802 (0.05%) 
Cystitis *  5/21893 (0.02%)  12/21802 (0.06%) 
Herpes zoster *  7/21893 (0.03%)  9/21802 (0.04%) 
Respiratory tract infection *  7/21893 (0.03%)  9/21802 (0.04%) 
Wound infection *  8/21893 (0.04%)  7/21802 (0.03%) 
Staphylococcal infection *  8/21893 (0.04%)  5/21802 (0.02%) 
Urosepsis *  8/21893 (0.04%)  4/21802 (0.02%) 
Sinusitis *  3/21893 (0.01%)  7/21802 (0.03%) 
Osteomyelitis *  2/21893 (0.01%)  7/21802 (0.03%) 
Clostridial infection *  2/21893 (0.01%)  6/21802 (0.03%) 
Clostridium difficile colitis *  5/21893 (0.02%)  3/21802 (0.01%) 
Infection *  2/21893 (0.01%)  6/21802 (0.03%) 
Candidiasis *  5/21893 (0.02%)  2/21802 (0.01%) 
Cholecystitis infective *  4/21893 (0.02%)  3/21802 (0.01%) 
Gastroenteritis norovirus *  3/21893 (0.01%)  4/21802 (0.02%) 
Gastroenteritis viral *  3/21893 (0.01%)  4/21802 (0.02%) 
Escherichia urinary tract infection *  6/21893 (0.03%)  0/21802 (0.00%) 
Infected skin ulcer *  2/21893 (0.01%)  4/21802 (0.02%) 
Infective exacerbation of chronic obstructive airways diseas *  3/21893 (0.01%)  3/21802 (0.01%) 
Localised infection *  3/21893 (0.01%)  3/21802 (0.01%) 
Lower respiratory tract infection *  2/21893 (0.01%)  4/21802 (0.02%) 
Lung infection *  1/21893 (0.00%)  5/21802 (0.02%) 
Pharyngitis *  2/21893 (0.01%)  4/21802 (0.02%) 
Postoperative wound infection *  2/21893 (0.01%)  4/21802 (0.02%) 
Pyelonephritis acute *  4/21893 (0.02%)  2/21802 (0.01%) 
Injury, poisoning and procedural complications     
Femoral neck fracture *  35/21893 (0.16%)  53/21802 (0.24%) 
Femur fracture *  34/21893 (0.16%)  45/21802 (0.21%) 
Hip fracture *  23/21893 (0.11%)  34/21802 (0.16%) 
Humerus fracture *  19/21893 (0.09%)  35/21802 (0.16%) 
Rib fracture *  21/21893 (0.10%)  14/21802 (0.06%) 
Toxicity to various agents *  17/21893 (0.08%)  18/21802 (0.08%) 
Radius fracture *  13/21893 (0.06%)  20/21802 (0.09%) 
Contusion *  20/21893 (0.09%)  12/21802 (0.06%) 
Ankle fracture *  14/21893 (0.06%)  15/21802 (0.07%) 
Concussion *  10/21893 (0.05%)  16/21802 (0.07%) 
Upper limb fracture *  9/21893 (0.04%)  17/21802 (0.08%) 
Spinal compression fracture *  14/21893 (0.06%)  11/21802 (0.05%) 
Wrist fracture *  15/21893 (0.07%)  10/21802 (0.05%) 
Pelvic fracture *  9/21893 (0.04%)  11/21802 (0.05%) 
Subdural haematoma *  5/21893 (0.02%)  15/21802 (0.07%) 
Lumbar vertebral fracture *  9/21893 (0.04%)  10/21802 (0.05%) 
Road traffic accident *  9/21893 (0.04%)  9/21802 (0.04%) 
Facial bones fracture *  9/21893 (0.04%)  8/21802 (0.04%) 
Head injury *  9/21893 (0.04%)  8/21802 (0.04%) 
Joint dislocation *  5/21893 (0.02%)  11/21802 (0.05%) 
Spinal fracture *  6/21893 (0.03%)  9/21802 (0.04%) 
Laceration *  8/21893 (0.04%)  6/21802 (0.03%) 
Lower limb fracture *  8/21893 (0.04%)  6/21802 (0.03%) 
Fall *  4/21893 (0.02%)  9/21802 (0.04%) 
Tendon rupture *  10/21893 (0.05%)  3/21802 (0.01%) 
Fibula fracture *  7/21893 (0.03%)  4/21802 (0.02%) 
Tibia fracture *  3/21893 (0.01%)  8/21802 (0.04%) 
Traumatic brain injury *  5/21893 (0.02%)  5/21802 (0.02%) 
Cervical vertebral fracture *  5/21893 (0.02%)  4/21802 (0.02%) 
Hand fracture *  4/21893 (0.02%)  5/21802 (0.02%) 
Meniscus lesion *  1/21893 (0.00%)  8/21802 (0.04%) 
Foot fracture *  5/21893 (0.02%)  3/21802 (0.01%) 
Forearm fracture *  7/21893 (0.03%)  1/21802 (0.00%) 
Brain contusion *  2/21893 (0.01%)  5/21802 (0.02%) 
Multiple injuries *  3/21893 (0.01%)  4/21802 (0.02%) 
Overdose *  3/21893 (0.01%)  4/21802 (0.02%) 
Pubis fracture *  1/21893 (0.00%)  6/21802 (0.03%) 
Thoracic vertebral fracture *  3/21893 (0.01%)  4/21802 (0.02%) 
Ulna fracture *  3/21893 (0.01%)  4/21802 (0.02%) 
Injury *  3/21893 (0.01%)  3/21802 (0.01%) 
Multiple fractures *  2/21893 (0.01%)  4/21802 (0.02%) 
Post procedural haemorrhage *  1/21893 (0.00%)  5/21802 (0.02%) 
Metabolism and nutrition disorders     
Dehydration *  24/21893 (0.11%)  25/21802 (0.11%) 
Diabetes mellitus inadequate control *  22/21893 (0.10%)  20/21802 (0.09%) 
Hypoglycaemia *  23/21893 (0.11%)  18/21802 (0.08%) 
Diabetes mellitus *  18/21893 (0.08%)  18/21802 (0.08%) 
Type 2 diabetes mellitus *  16/21893 (0.07%)  12/21802 (0.06%) 
Hyponatraemia *  9/21893 (0.04%)  11/21802 (0.05%) 
Hypokalaemia *  8/21893 (0.04%)  9/21802 (0.04%) 
Diabetic foot *  5/21893 (0.02%)  7/21802 (0.03%) 
Hyperkalaemia *  3/21893 (0.01%)  5/21802 (0.02%) 
Hypercholesterolaemia *  3/21893 (0.01%)  4/21802 (0.02%) 
Hyperglycaemia *  5/21893 (0.02%)  2/21802 (0.01%) 
Cachexia *  3/21893 (0.01%)  3/21802 (0.01%) 
Electrolyte imbalance *  3/21893 (0.01%)  3/21802 (0.01%) 
Gout *  6/21893 (0.03%)  0/21802 (0.00%) 
Hypomagnesaemia *  1/21893 (0.00%)  5/21802 (0.02%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis *  87/21893 (0.40%)  108/21802 (0.50%) 
Intervertebral disc protrusion *  18/21893 (0.08%)  26/21802 (0.12%) 
Back pain *  15/21893 (0.07%)  20/21802 (0.09%) 
Spinal column stenosis *  19/21893 (0.09%)  14/21802 (0.06%) 
Rotator cuff syndrome *  8/21893 (0.04%)  12/21802 (0.06%) 
Arthralgia *  6/21893 (0.03%)  12/21802 (0.06%) 
Polymyalgia rheumatica *  12/21893 (0.05%)  5/21802 (0.02%) 
Intervertebral disc degeneration *  6/21893 (0.03%)  10/21802 (0.05%) 
Lumbar spinal stenosis *  7/21893 (0.03%)  9/21802 (0.04%) 
Rheumatoid arthritis *  8/21893 (0.04%)  8/21802 (0.04%) 
Spinal osteoarthritis *  8/21893 (0.04%)  8/21802 (0.04%) 
Arthritis *  5/21893 (0.02%)  4/21802 (0.02%) 
Bone pain *  5/21893 (0.02%)  2/21802 (0.01%) 
Osteonecrosis *  4/21893 (0.02%)  3/21802 (0.01%) 
Foot deformity *  2/21893 (0.01%)  4/21802 (0.02%) 
Intervertebral disc disorder *  4/21893 (0.02%)  2/21802 (0.01%) 
Musculoskeletal pain *  6/21893 (0.03%)  0/21802 (0.00%) 
Pain in extremity *  4/21893 (0.02%)  2/21802 (0.01%) 
Spondylolisthesis *  2/21893 (0.01%)  4/21802 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer *  57/21893 (0.26%)  60/21802 (0.28%) 
Breast cancer *  48/21893 (0.22%)  46/21802 (0.21%) 
Colon cancer *  44/21893 (0.20%)  35/21802 (0.16%) 
Lung neoplasm malignant *  24/21893 (0.11%)  38/21802 (0.17%) 
Bladder cancer *  20/21893 (0.09%)  19/21802 (0.09%) 
Basal cell carcinoma *  12/21893 (0.05%)  21/21802 (0.10%) 
Gastric cancer *  15/21893 (0.07%)  13/21802 (0.06%) 
Pancreatic carcinoma *  15/21893 (0.07%)  12/21802 (0.06%) 
Rectal cancer *  10/21893 (0.05%)  13/21802 (0.06%) 
Bladder neoplasm *  13/21893 (0.06%)  9/21802 (0.04%) 
Squamous cell carcinoma *  8/21893 (0.04%)  9/21802 (0.04%) 
Malignant melanoma *  9/21893 (0.04%)  7/21802 (0.03%) 
Renal cancer *  10/21893 (0.05%)  6/21802 (0.03%) 
Hepatic neoplasm malignant *  8/21893 (0.04%)  7/21802 (0.03%) 
Pancreatic carcinoma metastatic *  7/21893 (0.03%)  8/21802 (0.04%) 
Lung adenocarcinoma *  7/21893 (0.03%)  7/21802 (0.03%) 
Neoplasm malignant *  9/21893 (0.04%)  5/21802 (0.02%) 
Lymphoma *  9/21893 (0.04%)  4/21802 (0.02%) 
Thyroid cancer *  8/21893 (0.04%)  5/21802 (0.02%) 
Metastases to liver *  6/21893 (0.03%)  6/21802 (0.03%) 
Prostatic adenoma *  7/21893 (0.03%)  5/21802 (0.02%) 
Colon cancer metastatic *  6/21893 (0.03%)  5/21802 (0.02%) 
Brain neoplasm *  5/21893 (0.02%)  5/21802 (0.02%) 
Lung neoplasm *  4/21893 (0.02%)  6/21802 (0.03%) 
Transitional cell carcinoma *  6/21893 (0.03%)  4/21802 (0.02%) 
Uterine cancer *  6/21893 (0.03%)  4/21802 (0.02%) 
Bronchial carcinoma *  4/21893 (0.02%)  5/21802 (0.02%) 
Non-hodgkin’s lymphoma *  6/21893 (0.03%)  3/21802 (0.01%) 
Breast cancer metastatic *  4/21893 (0.02%)  4/21802 (0.02%) 
Chronic lymphocytic leukaemia *  3/21893 (0.01%)  5/21802 (0.02%) 
Colon neoplasm *  3/21893 (0.01%)  5/21802 (0.02%) 
Lung cancer metastatic *  4/21893 (0.02%)  4/21802 (0.02%) 
Oesophageal carcinoma *  5/21893 (0.02%)  3/21802 (0.01%) 
Renal neoplasm *  6/21893 (0.03%)  2/21802 (0.01%) 
Acute myeloid leukaemia *  2/21893 (0.01%)  5/21802 (0.02%) 
Adenocarcinoma *  4/21893 (0.02%)  3/21802 (0.01%) 
Colon adenoma *  2/21893 (0.01%)  5/21802 (0.02%) 
Endometrial cancer *  4/21893 (0.02%)  3/21802 (0.01%) 
Hepatic neoplasm *  5/21893 (0.02%)  2/21802 (0.01%) 
Metastatic malignant melanoma *  4/21893 (0.02%)  3/21802 (0.01%) 
Metastatic neoplasm *  3/21893 (0.01%)  4/21802 (0.02%) 
Multiple myeloma *  3/21893 (0.01%)  4/21802 (0.02%) 
Prostate cancer metastatic *  1/21893 (0.00%)  6/21802 (0.03%) 
Renal cancer metastatic *  1/21893 (0.00%)  6/21802 (0.03%) 
Breast cancer recurrent *  4/21893 (0.02%)  2/21802 (0.01%) 
Meningioma *  2/21893 (0.01%)  4/21802 (0.02%) 
Metastases to lung *  1/21893 (0.00%)  5/21802 (0.02%) 
Ovarian neoplasm *  3/21893 (0.01%)  3/21802 (0.01%) 
Renal cell carcinoma *  1/21893 (0.00%)  5/21802 (0.02%) 
Nervous system disorders     
Cerebrovascular accident *  196/21893 (0.90%)  180/21802 (0.83%) 
Transient ischaemic attack *  69/21893 (0.32%)  57/21802 (0.26%) 
Syncope *  54/21893 (0.25%)  43/21802 (0.20%) 
Cerebrovascular disorder *  24/21893 (0.11%)  21/21802 (0.10%) 
Ischaemic stroke *  17/21893 (0.08%)  28/21802 (0.13%) 
Cerebral infarction *  23/21893 (0.11%)  11/21802 (0.05%) 
Epilepsy *  14/21893 (0.06%)  11/21802 (0.05%) 
Carotid artery stenosis *  13/21893 (0.06%)  10/21802 (0.05%) 
Vascular dementia *  12/21893 (0.05%)  7/21802 (0.03%) 
Cerebral ischaemia *  9/21893 (0.04%)  9/21802 (0.04%) 
Cerebral haemorrhage *  9/21893 (0.04%)  4/21802 (0.02%) 
Dementia *  4/21893 (0.02%)  9/21802 (0.04%) 
Dementia alzheimer’s type *  9/21893 (0.04%)  4/21802 (0.02%) 
Dizziness *  5/21893 (0.02%)  8/21802 (0.04%) 
Parkinson’s disease *  8/21893 (0.04%)  5/21802 (0.02%) 
Presyncope *  9/21893 (0.04%)  4/21802 (0.02%) 
Grand mal convulsion *  4/21893 (0.02%)  8/21802 (0.04%) 
Sciatica *  7/21893 (0.03%)  5/21802 (0.02%) 
Cerebral arteriosclerosis *  7/21893 (0.03%)  4/21802 (0.02%) 
Subarachnoid haemorrhage *  7/21893 (0.03%)  4/21802 (0.02%) 
Brain oedema *  3/21893 (0.01%)  7/21802 (0.03%) 
Haemorrhagic stroke *  5/21893 (0.02%)  4/21802 (0.02%) 
Vertebrobasilar insufficiency *  4/21893 (0.02%)  5/21802 (0.02%) 
Convulsion *  3/21893 (0.01%)  5/21802 (0.02%) 
Encephalopathy *  6/21893 (0.03%)  2/21802 (0.01%) 
Parkinsonism *  6/21893 (0.03%)  1/21802 (0.00%) 
Brain stem infarction *  3/21893 (0.01%)  3/21802 (0.01%) 
Embolic stroke *  3/21893 (0.01%)  3/21802 (0.01%) 
Vascular encephalopathy *  2/21893 (0.01%)  4/21802 (0.02%) 
Psychiatric disorders     
Depression *  24/21893 (0.11%)  20/21802 (0.09%) 
Completed suicide *  5/21893 (0.02%)  7/21802 (0.03%) 
Delirium *  6/21893 (0.03%)  4/21802 (0.02%) 
Confusional state *  4/21893 (0.02%)  4/21802 (0.02%) 
Renal and urinary disorders     
Renal failure acute *  60/21893 (0.27%)  45/21802 (0.21%) 
Renal failure chronic *  27/21893 (0.12%)  30/21802 (0.14%) 
Renal failure *  26/21893 (0.12%)  27/21802 (0.12%) 
Nephrolithiasis *  14/21893 (0.06%)  20/21802 (0.09%) 
Urinary retention *  13/21893 (0.06%)  15/21802 (0.07%) 
Haematuria *  8/21893 (0.04%)  8/21802 (0.04%) 
Calculus ureteric *  10/21893 (0.05%)  4/21802 (0.02%) 
Urethral stenosis *  3/21893 (0.01%)  10/21802 (0.05%) 
Calculus bladder *  6/21893 (0.03%)  5/21802 (0.02%) 
Hydronephrosis *  8/21893 (0.04%)  3/21802 (0.01%) 
Urinary bladder polyp *  3/21893 (0.01%)  6/21802 (0.03%) 
Calculus urinary *  2/21893 (0.01%)  6/21802 (0.03%) 
Cystitis haemorrhagic *  5/21893 (0.02%)  3/21802 (0.01%) 
Bladder neck obstruction *  1/21893 (0.00%)  5/21802 (0.02%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia *  27/21893 (0.12%)  31/21802 (0.14%) 
Uterine prolapse *  7/21893 (0.03%)  3/21802 (0.01%) 
Ovarian cyst *  4/21893 (0.02%)  5/21802 (0.02%) 
Prostatitis *  3/21893 (0.01%)  4/21802 (0.02%) 
Uterine polyp *  4/21893 (0.02%)  3/21802 (0.01%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease *  141/21893 (0.64%)  128/21802 (0.59%) 
Pulmonary embolism *  47/21893 (0.21%)  61/21802 (0.28%) 
Bronchitis *  61/21893 (0.28%)  43/21802 (0.20%) 
Respiratory failure *  32/21893 (0.15%)  37/21802 (0.17%) 
Asthma *  33/21893 (0.15%)  17/21802 (0.08%) 
Pulmonary oedema *  19/21893 (0.09%)  24/21802 (0.11%) 
Acute respiratory failure *  22/21893 (0.10%)  15/21802 (0.07%) 
Pleural effusion *  15/21893 (0.07%)  19/21802 (0.09%) 
Bronchitis chronic *  14/21893 (0.06%)  14/21802 (0.06%) 
Pneumonia aspiration *  10/21893 (0.05%)  14/21802 (0.06%) 
Dyspnoea *  13/21893 (0.06%)  10/21802 (0.05%) 
Epistaxis *  13/21893 (0.06%)  9/21802 (0.04%) 
Pneumothorax *  7/21893 (0.03%)  4/21802 (0.02%) 
Acute pulmonary oedema *  2/21893 (0.01%)  8/21802 (0.04%) 
Emphysema *  2/21893 (0.01%)  7/21802 (0.03%) 
Pleurisy *  6/21893 (0.03%)  3/21802 (0.01%) 
Pulmonary fibrosis *  2/21893 (0.01%)  6/21802 (0.03%) 
Sleep apnoea syndrome *  3/21893 (0.01%)  5/21802 (0.02%) 
Pulmonary hypertension *  4/21893 (0.02%)  3/21802 (0.01%) 
Bronchiectasis *  5/21893 (0.02%)  1/21802 (0.00%) 
Interstitial lung disease *  3/21893 (0.01%)  3/21802 (0.01%) 
Respiratory arrest *  3/21893 (0.01%)  3/21802 (0.01%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer *  6/21893 (0.03%)  7/21802 (0.03%) 
Skin ulcer *  5/21893 (0.02%)  6/21802 (0.03%) 
Angioedema *  4/21893 (0.02%)  5/21802 (0.02%) 
Vascular disorders     
Hypertension *  82/21893 (0.37%)  83/21802 (0.38%) 
Arteriosclerosis *  22/21893 (0.10%)  30/21802 (0.14%) 
Hypertensive crisis *  26/21893 (0.12%)  21/21802 (0.10%) 
Circulatory collapse *  23/21893 (0.11%)  18/21802 (0.08%) 
Deep vein thrombosis *  13/21893 (0.06%)  24/21802 (0.11%) 
Peripheral arterial occlusive disease *  19/21893 (0.09%)  13/21802 (0.06%) 
Aortic aneurysm *  13/21893 (0.06%)  15/21802 (0.07%) 
Hypotension *  14/21893 (0.06%)  13/21802 (0.06%) 
Haematoma *  15/21893 (0.07%)  8/21802 (0.04%) 
Peripheral vascular disorder *  11/21893 (0.05%)  11/21802 (0.05%) 
Aortic stenosis *  11/21893 (0.05%)  7/21802 (0.03%) 
Venous thrombosis *  9/21893 (0.04%)  8/21802 (0.04%) 
Thrombophlebitis *  7/21893 (0.03%)  5/21802 (0.02%) 
Thrombosis *  4/21893 (0.02%)  8/21802 (0.04%) 
Orthostatic hypotension *  5/21893 (0.02%)  6/21802 (0.03%) 
Arterial occlusive disease *  4/21893 (0.02%)  6/21802 (0.03%) 
Intermittent claudication *  4/21893 (0.02%)  6/21802 (0.03%) 
Peripheral ischaemia *  5/21893 (0.02%)  4/21802 (0.02%) 
Arterial thrombosis limb *  4/21893 (0.02%)  4/21802 (0.02%) 
Hypovolaemic shock *  5/21893 (0.02%)  2/21802 (0.01%) 
Varicose vein *  6/21893 (0.03%)  1/21802 (0.00%) 
Venous thrombosis limb *  3/21893 (0.01%)  3/21802 (0.01%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.5%
FluNG Group Fluarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1999/3015 (66.30%)   1360/3002 (45.30%) 
General disorders     
Pain  [1]  1225/3015 (40.63%)  477/3002 (15.89%) 
Redness  [1]  240/3015 (7.96%)  66/3002 (2.20%) 
Swelling  [1]  189/3015 (6.27%)  40/3002 (1.33%) 
Pain  [2]  998/3015 (33.10%)  440/3002 (14.66%) 
Redness  [2]  212/3015 (7.03%)  54/3002 (1.80%) 
Swelling  [2]  173/3015 (5.74%)  38/3002 (1.27%) 
Arthralgia  [1]  391/3015 (12.97%)  239/3002 (7.96%) 
Fatigue  [1]  646/3015 (21.43%)  417/3002 (13.89%) 
Gastrointestinal  [1]  197/3015 (6.53%)  165/3002 (5.50%) 
Headache  [1]  474/3015 (15.72%)  333/3002 (11.09%) 
Myalgia  [1]  547/3015 (18.14%)  302/3002 (10.06%) 
Shivering  [1]  245/3015 (8.13%)  80/3002 (2.66%) 
Arthralgia  [2]  258/3015 (8.56%)  176/3002 (5.86%) 
Fatigue  [2]  457/3015 (15.16%)  318/3002 (10.59%) 
Gastrointestinal  [2]  137/3015 (4.54%)  124/3002 (4.13%) 
Headache  [2]  342/3015 (11.34%)  237/3002 (7.89%) 
Myalgia  [2]  380/3015 (12.60%)  209/3002 (6.96%) 
Shivering  [2]  189/3015 (6.27%)  88/3002 (2.93%) 
Indicates events were collected by systematic assessment
[1]
During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
[2]
During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00753272     History of Changes
Other Study ID Numbers: 106372
First Submitted: September 12, 2008
First Posted: September 16, 2008
Results First Submitted: April 26, 2012
Results First Posted: June 19, 2012
Last Update Posted: June 8, 2018