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: July 11, 2013
Last verified: November 2012
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 Disease
Interventions: Biological: GSK Bio's influenza vaccine GSK2186877A
Biological: Fluarix TM

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide All Outcome Measures

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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information