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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00753272
First received: September 12, 2008
Last updated: September 20, 2016
Last verified: September 2016
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: GSK Bio's influenza vaccine GSK2186877A
Biological: Fluarix TM

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).
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).

Participant Flow:   Overall Study
    FluNG Group   Fluarix Group
STARTED   21893   21802 
COMPLETED   16911   16895 
NOT COMPLETED   4982   4907 
Adverse Event                878                869 
Protocol Violation                28                46 
Withdrawal by Subject                2481                2407 
Lost to Follow-up                491                497 
Unspecified                1104                1088 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
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).
Total Total of all reporting groups

Baseline Measures
   FluNG Group   Fluarix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 21893   21802   43695 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Years   73.5  (6.09)   73.5  (6.16)   73.5  (6.13) 
Gender 
[Units: Subjects]
     
Female   12549   12422   24971 
Male   9344   9380   18724 


  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.   [ 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)) ]

Measure Type Primary
Measure Title Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
Measure 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))  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21573   21482 
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. 
[Units: Subjects]
 274   310 

No statistical analysis provided for Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.



2.  Primary:   Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.   [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ]

Measure Type Primary
Measure Title Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).
FluNG Lot 1 Group 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.
FluNG Lot 2 Group 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.
FluNG Lot 3 Group 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.

Measured Values
   FluNG Group   Fluarix Group   FluNG Lot 1 Group   FluNG Lot 2 Group   FluNG Lot 3 Group 
Participants Analyzed 
[Units: Participants]
 0   0   540   538   534 
Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
         
A/Brisbane [Day 0] (N=539,536,532)         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] (N=540,538,534)         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] (N=539,536,532)         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] (N=540,538,534)         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] (N=539,536,532)         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] (N=540,538,534)         652.4 
 (602.0 to 707.1) 
 596.9 
 (552.2 to 645.3) 
 601.7 
 (555.0 to 652.4) 

No statistical analysis provided for Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.



3.  Secondary:   Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 20579   20458 
Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. 
[Units: Subjects]
 262   296 

No statistical analysis provided for Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.



4.  Secondary:   Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 20579   20458 
Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection. 
[Units: Subjects]
 144   145 

No statistical analysis provided for Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.



5.  Secondary:   Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21394   21337 
Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. 
[Units: Subjects]
 202   225 

No statistical analysis provided for Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.



6.  Secondary:   Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21394   21337 
Number of Subjects Reporting All-cause Death After the First Dose of Vaccine. 
[Units: Subjects]
 63   88 

No statistical analysis provided for Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.



7.  Secondary:   Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21394   21337 
Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine 
[Units: Subjects]
 84   89 

No statistical analysis provided for Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine



8.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).   [ Time Frame: Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21893   21802 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). 
[Units: Subjects]
   
Any AEs   70   60 
Grade 3 AEs   13   8 
Related AEs   11   7 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).



9.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).   [ Time Frame: Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 17070   17071 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). 
[Units: Subjects]
   
Any AEs   35   40 
Grade 3 AEs   9   6 
Related AEs   2   0 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).



10.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21893   21802 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). 
[Units: Subjects]
   
Any AEs   103   99 
Grade 3 AEs   22   14 
Related AEs   13   7 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).



11.  Secondary:   Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).   [ 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) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 21893   21802 
Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs). 
[Units: Subjects]
   
Any SAEs   4071   4066 
Related SAEs   9   6 

No statistical analysis provided for Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).



12.  Secondary:   Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2988   2968 
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms. 
[Units: Subjects]
   
Any ecchymosis   40   18 
Ecchymosis > 100 mm   0   0 
Any pain   1225   477 
Grade 3 pain   4   3 
Any redness   240   66 
Redness > 100 mm   6   3 
Any swelling   189   40 
Swelling > 100 mm   4   0 

No statistical analysis provided for Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.



13.  Secondary:   Number of Days With Any Grade of Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

Measure Type Secondary
Measure Title Number of Days With Any Grade of Solicited Local Symptoms
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 1221   476 
Number of Days With Any Grade of Solicited Local Symptoms 
[Units: Days]
Mean (Full Range)
   
Ecchymosis (N=39,18)   3.6 
 (1.0 to 7.0) 
 4.0 
 (1.0 to 7.0) 
Pain (N=1221,476)   2.5 
 (1.0 to 7.0) 
 2.1 
 (1.0 to 7.0) 
Redness (N=237,63)   2.9 
 (1.0 to 7.0) 
 2.5 
 (1.0 to 7.0) 
Swelling (N=186,40)   2.9 
 (1.0 to 7.0) 
 2.0 
 (1.0 to 7.0) 

No statistical analysis provided for Number of Days With Any Grade of Solicited Local Symptoms



14.  Secondary:   Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2441   2488 
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms 
[Units: Subjects]
   
Any ecchymosis   39   31 
Ecchymosis > 100 mm   1   0 
Any pain   998   440 
Grade 3 pain   13   7 
Any redness   212   54 
Redness > 100 mm   4   2 
Any swelling   173   38 
Swelling > 100 mm   3   0 

No statistical analysis provided for Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms



15.  Secondary:   Number of Days With Any Grade of Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

Measure Type Secondary
Measure Title Number of Days With Any Grade of Solicited Local Symptoms.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 995   431 
Number of Days With Any Grade of Solicited Local Symptoms. 
[Units: Days]
Mean (Full Range)
   
Ecchymosis (N=28,22)   2.8 
 (1.0 to 7.0) 
 3.6 
 (1.0 to 7.0) 
Pain (N=995,431)   2.5 
 (1.0 to 7.0) 
 2.0 
 (1.0 to 7.0) 
Redness (N=202,46)   2.8 
 (1.0 to 7.0) 
 2.6 
 (1.0 to 7.0) 
Swelling (N=162,25)   2.5 
 (1.0 to 7.0) 
 2.7 
 (1.0 to 7.0) 

No statistical analysis provided for Number of Days With Any Grade of Solicited Local Symptoms.



16.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2986   2968 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms 
[Units: Subjects]
   
Any arthralgia   391   239 
Grade 3 arthralgia   11   5 
Related arthralgia   285   163 
Any fatigue   646   417 
Grade 3 fatigue   20   15 
Related fatigue   494   295 
Any gastrointestinal   197   165 
Grade 3 gastrointestinal   6   4 
Related gastrointestinal   132   82 
Any headache   474   333 
Grade 3 headache   8   4 
Related headache   341   213 
Any myalgia   547   302 
Grade 3 myalgia   14   11 
Related myalgia   412   203 
Any shivering   245   80 
Grade 3 shivering   12   2 
Related shivering   185   49 
Temperature >= 38.0°C   72   20 
Temperature >= 39.0°C - <=40.0°C   5   2 
Related temperature   51   14 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms



17.  Secondary:   Number of Days With Any Grade of Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

Measure Type Secondary
Measure Title Number of Days With Any Grade of Solicited General Symptoms
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 642   417 
Number of Days With Any Grade of Solicited General Symptoms 
[Units: Days]
Mean (Full Range)
   
Arthralgia (N=388,239)   2.8 
 (1.0 to 7.0) 
 2.9 
 (1.0 to 7.0) 
Fatigue (N=642,417)   2.5 
 (1.0 to 7.0) 
 2.7 
 (1.0 to 7.0) 
Gastrointestinal (N=195,164)   2.2 
 (1.0 to 7.0) 
 2.2 
 (1.0 to 7.0) 
Headache (N=472,332)   2.2 
 (1.0 to 7.0) 
 2.3 
 (1.0 to 7.0) 
Myalgia (N=544,301)   2.3 
 (1.0 to 7.0) 
 2.3 
 (1.0 to 7.0) 
Shivering (N=244,80)   1.6 
 (1.0 to 7.0) 
 2.1 
 (1.0 to 7.0) 
Temperature (N=59,16)   1.4 
 (1.0 to 7.0) 
 1.3 
 (1.0 to 4.0) 

No statistical analysis provided for Number of Days With Any Grade of Solicited General Symptoms



18.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2436   2489 
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms. 
[Units: Subjects]
   
Any arthralgia   258   176 
Grade 3 arthralgia   10   4 
Related arthralgia   169   90 
Any fatigue   457   318 
Grade 3 fatigue   8   6 
Related fatigue   307   169 
Any gastrointestinal   137   124 
Grade 3 gastrointestinal   5   8 
Related gastrointestinal   71   46 
Any headache   342   237 
Grade 3 headache   10   4 
Related headache   219   119 
Any myalgia   380   209 
Grade 3 myalgia   11   6 
Related myalgia   261   117 
Any shivering   189   88 
Grade 3 shivering   11   6 
Related shivering   127   44 
Temperature >= 38.0°C   52   25 
Temperature >= 39.0°C - <= 40.0°C   5   2 
Related temperature   33   7 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.



19.  Secondary:   Number of Days With Any Grade of Solicited General Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

Measure Type Secondary
Measure Title Number of Days With Any Grade of Solicited General Symptoms.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 446   313 
Number of Days With Any Grade of Solicited General Symptoms. 
[Units: Days]
Mean (Full Range)
   
Arthralgia (N=247,169)   2.7 
 (1.0 to 7.0) 
 3.0 
 (1.0 to 7.0) 
Fatigue (N=446,313)   2.6 
 (1.0 to 7.0) 
 2.7 
 (1.0 to 7.0) 
Gastrointestinal (N=125,115)   2.3 
 (1.0 to 7.0) 
 2.6 
 (1.0 to 7.0) 
Headache (N=331,229)   2.2 
 (1.0 to 7.0) 
 2.4 
 (1.0 to 7.0) 
Myalgia (N=370,200)   2.4 
 (1.0 to 7.0) 
 2.6 
 (1.0 to 7.0) 
Shivering (N=177,80)   1.6 
 (1.0 to 7.0) 
 2.3 
 (1.0 to 7.0) 
Temperature (N=38,13)   1.2 
 (1.0 to 4.0) 
 1.5 
 (1.0 to 4.0) 

No statistical analysis provided for Number of Days With Any Grade of Solicited General Symptoms.



20.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).   [ Time Frame: Within 21 days (Days 0-20) after the first dose (Year 2008/2009) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 3015   3002 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). 
[Units: Subjects]
   
Any AEs   428   427 
Grade 3 AEs   48   52 
Related AEs   83   58 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).



21.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).   [ Time Frame: Within 21 days (Days 0-20) after the second dose (Year 2009/2010) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2462   2520 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). 
[Units: Subjects]
   
Any AEs   320   306 
Grade 3 AEs   36   26 
Related AEs   42   20 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).



22.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit   [ Time Frame: Within 180 days (Days 0-179) after the first dose (Year 2008/2009) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 3015   3002 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit 
[Units: Subjects]
   
Any AEs   1018   996 
Grade 3 AEs   223   211 
Related AEs   16   7 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit



23.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.   [ Time Frame: Within 180 days (Days 0-179) after the second dose (Year 2009/2010) ]

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2462   2520 
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit. 
[Units: Subjects]
   
Any AEs   849   864 
Grade 3 AEs   158   154 
Related AEs   7   5 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.



24.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.   [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ]

Measure Type Secondary
Measure Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 2422   2408 
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
A/Brisbane [Day 0] (N=2417,2397)   15.5 
 (14.9 to 16.1) 
 15.3 
 (14.7 to 16.0) 
A/Brisbane [Day 21] (N=2422,2408)   89.1 
 (85.2 to 93.2) 
 69.9 
 (66.5 to 73.4) 
A/Uruguay [Day 0] (N=2417,2397)   17.4 
 (16.6 to 18.3) 
 17.4 
 (16.5 to 18.2) 
A/Uruguay [Day 21] (N=2422,2408)   285.6 
 (270.6 to 301.4) 
 172.3 
 (162.7 to 182.5) 
B/Brisbane [Day 0] (N=2416,2397)   85.3 
 (81.2 to 89.7) 
 82.4 
 (78.3 to 86.7) 
B/Brisbane [Day 21] (N=2422,2408)   633.5 
 (609.9 to 658.0) 
 484.8 
 (465.1 to 505.4) 

No statistical analysis provided for Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.



25.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains   [ Time Frame: At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study ]

Measure Type Secondary
Measure Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 1938   1953 
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
A/Brisbane [Day 0] (N=1932,1942)   23.9 
 (22.9 to 25.0) 
 24.3 
 (23.2 to 25.5) 
A/Brisbane [Day 21] (N=1936,1952)   76.9 
 (73.6 to 80.4) 
 70.5 
 (67.1 to 74.0) 
A/Uruguay [Day 0] (N=1932,1942)   57.8 
 (54.5 to 61.3) 
 46.5 
 (43.9 to 49.4) 
A/Uruguay [Day 21] (N=1937,1953)   256.8 
 (245.3 to 268.9) 
 162.0 
 (153.9 to 170.4) 
B/Brisbane [Day 0] (N=1933,1942)   58.6 
 (55.6 to 61.8) 
 56.6 
 (53.6 to 59.7) 
B/Brisbane [Day 21] (N=1938,1953)   199.2 
 (190.8 to 207.9) 
 171.3 
 (163.6 to 179.4) 

No statistical analysis provided for Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains



26.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.   [ 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 ]

Measure Type Secondary
Measure Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 268   267 
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
A/Brisbane [Day 0] (N=268,265)   15.4 
 (13.7 to 17.4) 
 13.9 
 (12.4 to 15.6) 
A/Brisbane [Day 21] (N=268,267)   75.4 
 (66.3 to 85.9) 
 64.5 
 (55.7 to 74.7) 
A/Brisbane [Day 180] (N=268,267)   30.4 
 (26.8 to 34.4) 
 28.1 
 (24.8 to 31.8) 
A/Uruguay [Day 0] (N=268,265)   19.3 
 (16.5 to 22.6) 
 17.8 
 (15.3 to 20.7) 
A/Uruguay [Day 21] (N=268,267)   275.0 
 (233.1 to 324.5) 
 165.0 
 (139.0 to 195.9) 
A/Uruguay [Day 180] (N=268,267)   97.7 
 (82.3 to 116.0) 
 64.0 
 (53.7 to 76.3) 
B/Brisbane [Day 0] (N=268,265)   89.3 
 (76.6 to 104.2) 
 83.8 
 (72.3 to 97.1) 
B/Brisbane [Day 21] (N=268,267)   573.4 
 (517.5 to 635.3) 
 478.5 
 (422.4 to 541.9) 
A/Brisbane [Day 180] (N=268,267)   274.6 
 (246.5 to 305.9) 
 262.3 
 (234.7 to 293.1) 

No statistical analysis provided for Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.



27.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.   [ 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 ]

Measure Type Secondary
Measure Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).

Measured Values
   FluNG Group   Fluarix Group 
Participants Analyzed 
[Units: Participants]
 189   177 
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. 
[Units: Titers]
Geometric Mean (95% Confidence Interval)
   
A/Brisbane [Day 0] (N=188,177)   23.4 
 (20.3 to 27.1) 
 25.0 
 (21.3 to 29.3) 
A/Brisbane [Day 21] (N=188,176)   80.0 
 (69.4 to 92.2) 
 75.0 
 (63.4 to 88.6) 
A/Brisbane [Day 180] (N=189,177)   28.5 
 (24.7 to 32.8) 
 27.3 
 (23.5 to 31.7) 
A/Uruguay [Day 0] (N=188,177)   68.9 
 (56.2 to 84.5) 
 54.2 
 (44.1 to 66.5) 
A/Uruguay [Day 21] (N=188,176)   300.6 
 (254.0 to 355.7) 
 195.6 
 (165.5 to 231.2) 
A/Uruguay [Day 180] (N=189,177)   105.7 
 (87.9 to 127.2) 
 63.6 
 (53.0 to 76.3) 
B/Brisbane [Day 0] (N=189,177)   58.5 
 (48.8 to 70.1) 
 56.1 
 (47.0 to 67.0) 
B/Brisbane [Day 21] (N=189,176)   225.1 
 (195.5 to 259.1) 
 191.0 
 (161.3 to 226.3) 
B/Brisbane [Day 180] (N=189,177)   122.9 
 (106.5 to 141.7) 
 111.6 
 (95.8 to 130.0) 

No statistical analysis provided for Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.



28.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains   [ Time Frame: At Day 21 of the first year (2008/2009) of the study. ]

Measure Type Secondary
Measure Title Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains
Measure 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.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).
FluNG Lot 1 Group 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.
FluNG Lot 2 Group 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.
FluNG Lot 3 Group 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.

Measured Values
   FluNG Group   Fluarix Group   FluNG Lot 1 Group   FluNG Lot 2 Group   FluNG Lot 3 Group 
Participants Analyzed 
[Units: Participants]
 0   0   539   536   532 
Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains 
[Units: Subjects]
         
A/Brisbane (N=539,536,532)         307   298   310 
A/Uruguay (N=539,536,532)         471   461   455 
B/Brisbane (N=539,536,532)         389   350   363 

No statistical analysis provided for Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains




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