Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00963157
First received: August 20, 2009
Last updated: April 11, 2013
Last verified: January 2011
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Inactivated H1N1 Vaccine
Biological: AS03

  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
Participants were healthy adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Participant Flow:   Overall Study
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
STARTED     156     163     160     157     153  
COMPLETED     151     159     155     150     151  
NOT COMPLETED     5     4     5     7     2  



  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
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted     Total  
Number of Participants  
[units: participants]
  156     163     160     157     153     789  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     107     111     110     109     107     544  
>=65 years     49     52     50     48     46     245  
Age  
[units: years]
Mean ± Standard Deviation
  51.3  ± 17.6     51.7  ± 18.0     51.6  ± 17.8     50.1  ± 18.3     52.1  ± 18.6     51.4  ± 18.0  
Gender  
[units: participants]
           
Female     89     84     93     85     72     423  
Male     67     79     67     72     81     366  
Region of Enrollment  
[units: participants]
           
United States     156     163     160     157     153     789  



  Outcome Measures
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1.  Primary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 8 days after the first H1N1 vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to an eligibility deviation. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  106     110     110     107     107  
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  84     95     62     94     80  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine



2.  Primary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the first H1N1 vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  105     109     105     104     105  
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  90     96     72     96     86  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine



3.  Primary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 8 days after the first H1N1 vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to influenza-like illness. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  49     52     50     47     46  
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  24     30     17     34     21  

No statistical analysis provided for Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine



4.  Primary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the first H1N1 vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  48     52     48     45     44  
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  32     37     19     37     24  

No statistical analysis provided for Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine



5.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 365 after the last vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Measure Description Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Time Frame Day 0 through Day 365 after the last vaccination  
Safety Issue Yes  

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.
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  156     163     160     157     153  
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)  
[units: Participants]
  0     0     0     0     0  

No statistical analysis provided for Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)



6.  Primary:   Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination   [ Time Frame: 8-10 days after first vaccination ]

Measure Type Primary
Measure Title Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination
Measure Description Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.
Time Frame 8-10 days after first vaccination  
Safety Issue Yes  

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.
Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  151     159     159     151     149  
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination  
[units: Participants]
         
Prothrombin time     2     1     0     1     1  
Partial thromboplastin time     3     1     1     1     1  
Platelets     1     3     2     2     6  
White blood cells     3     6     8     7     12  
Neutrophils     2     3     5     3     8  
Lymphocytes     3     1     5     2     1  

No statistical analysis provided for Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination



7.  Primary:   Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination   [ Time Frame: 8-10 days after second vaccination ]

Measure Type Primary
Measure Title Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination
Measure Description Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.
Time Frame 8-10 days after second vaccination  
Safety Issue Yes  

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.
Participants who received at least the first vaccination and had blood collection at the timepoint are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  150     158     155     155     147  
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination  
[units: Participants]
         
Prothrombin time     1     2     0     1     1  
Partial thromboplastin time     4     3     0     3     3  
Platelets     3     2     2     3     2  
White blood cells     8     5     9     8     9  
Neutrophils     8     5     2     5     7  
Lymphocytes     4     0     3     1     4  

No statistical analysis provided for Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination



8.  Primary:   Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination   [ Time Frame: 8-10 days after first vaccination ]

Measure Type Primary
Measure Title Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination
Measure Description Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.
Time Frame 8-10 days after first vaccination  
Safety Issue Yes  

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.
Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  155     161     160     156     153  
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination  
[units: Participants]
         
Sodium     0     1     1     2     3  
Potassium     2     1     2     1     1  
Creatinine     5     6     4     2     3  
Alanine transaminase     0     1     3     1     2  
Albumin     0     0     0     0     0  
Total protein     2     0     0     0     0  

No statistical analysis provided for Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination



9.  Primary:   Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination   [ Time Frame: 8-10 days after second vaccination ]

Measure Type Primary
Measure Title Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination
Measure Description Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.
Time Frame 8-10 days after second vaccination  
Safety Issue Yes  

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.
Participants who received at least the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  150     158     154     153     147  
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination  
[units: Participants]
         
Sodium     1     0     2     2     0  
Potassium     0     1     1     0     0  
Creatinine     2     3     3     0     3  
Alanine transaminase     1     1     1     2     0  
Albumin     0     0     0     0     0  
Total protein     1     0     0     0     1  

No statistical analysis provided for Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination



10.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post first vaccination  
Safety Issue Yes  

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.
Participants who received the first vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  156     163     160     157     153  
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination  
[units: Participants]
         
Feverishness     15     18     5     22     10  
Malaise     42     41     29     44     32  
Myalgia     32     43     13     45     24  
Headache     40     38     35     35     38  
Nausea     12     9     7     12     10  
Chills     17     15     5     12     12  
Arthralgia     13     11     4     18     9  
Shivering     7     9     3     7     5  

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination



11.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post second vaccination  
Safety Issue Yes  

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.
Participants who received the second vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  147     151     151     147     140  
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination  
[units: Participants]
         
Feverishness     27     25     6     32     8  
Malaise     47     41     17     40     19  
Myalgia     38     39     10     35     14  
Headache     35     47     27     31     21  
Nausea     16     10     5     10     5  
Chills     19     18     3     20     5  
Arthralgia     11     17     6     13     9  
Shivering     14     10     3     16     2  

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination



12.  Primary:   Number of Participants Reporting Fever After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Fever After the First Vaccination
Measure Description Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post first vaccination  
Safety Issue Yes  

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.
Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  156     163     159     156     153  
Number of Participants Reporting Fever After the First Vaccination  
[units: Participants]
  2     4     0     3     0  

No statistical analysis provided for Number of Participants Reporting Fever After the First Vaccination



13.  Primary:   Number of Participants Reporting Fever After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Fever After the Second Vaccination
Measure Description Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post second vaccination  
Safety Issue Yes  

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.
Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  147     151     151     147     140  
Number of Participants Reporting Fever After the Second Vaccination  
[units: Participants]
  8     4     0     6     0  

No statistical analysis provided for Number of Participants Reporting Fever After the Second Vaccination



14.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post first vaccination  
Safety Issue Yes  

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.
Participants who received the first vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  156     163     160     157     153  
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination  
[units: Participants]
         
Pain     90     96     25     90     35  
Tenderness     122     130     37     115     55  
Swelling     33     28     20     31     27  

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination



15.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post second vaccination  
Safety Issue Yes  

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.
Participants who received the second vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  147     151     151     147     140  
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination  
[units: Participants]
         
Pain     73     82     16     66     28  
Tenderness     104     112     37     100     51  
Swelling     26     19     24     27     20  

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination



16.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post first vaccination  
Safety Issue Yes  

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.
Participants who received the first vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  156     163     160     157     153  
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination  
[units: Participants]
         
Redness     41     36     33     44     40  
Swelling     36     30     22     32     28  

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination



17.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post second vaccination  
Safety Issue Yes  

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.
Participants who received the second vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  147     151     151     147     140  
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination  
[units: Participants]
         
Redness     28     29     30     40     30  
Swelling     27     17     25     30     23  

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination



18.  Primary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8 after the first vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to eligibility deviation. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  106     110     110     107     107  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  91     96     67     98     82  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine



19.  Primary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the first vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  105     109     105     104     105  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  95     97     78     99     87  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine



20.  Primary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8 after the first vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  49     52     50     47     46  
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  26     36     25     38     25  

No statistical analysis provided for Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine



21.  Primary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the first vaccination  
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.
Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  48     52     48     45     44  
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  34     42     27     40     27  

No statistical analysis provided for Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine



22.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  101     103     101     99     99  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  98     100     83     96     82  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine



23.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  100     103     101     99     96  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  98     100     80     97     79  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine



24.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 180 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  98     103     99     96     97  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  90     87     66     83     69  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



25.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 270 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 270 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  90     100     98     92     96  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  71     71     58     71     62  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine



26.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 8 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  44     47     46     41     37  
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  37     43     29     39     23  

No statistical analysis provided for Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine



27.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  44     47     46     40     37  
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  36     44     29     38     25  

No statistical analysis provided for Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine



28.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 180 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  44     47     46     40     36  
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  29     36     26     36     18  

No statistical analysis provided for Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



29.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 270 after the second vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 270 after the second vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  43     47     42     40     36  
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  21     30     16     30     13  

No statistical analysis provided for Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine



30.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 8 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  101     103     101     99     99  
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  95     98     79     93     80  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine



31.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  100     103     101     99     96  
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  95     99     76     95     78  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine



32.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 180 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  98     103     99     96     97  
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  82     83     56     79     65  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



33.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 270 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  90     100     98     92     96  
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  65     69     49     66     55  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine



34.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 8 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  44     47     46     41     37  
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  34     39     23     35     21  

No statistical analysis provided for Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine



35.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  44     47     46     40     37  
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  33     41     23     36     23  

No statistical analysis provided for Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine



36.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 180 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  44     47     46     40     36  
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  25     31     21     29     15  

No statistical analysis provided for Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



37.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]

Measure Type Secondary
Measure Title Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 270 days after the second H1N1 vaccination  
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.
Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
3.75 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 Mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 Mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 Mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine + AS03 Adjuvant     7.5 Mcg H1N1 Vaccine Unadjuvanted     15 Mcg H1N1 Vaccine + AS03 Adjuvant     15 Mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  43     47     42     40     36  
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  19     23     12     22     11  

No statistical analysis provided for Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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