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Sanofi H1N1 + TIV - Adults and Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00943878
First received: July 21, 2009
Last updated: July 26, 2012
Last verified: April 2010
Results First Received: April 14, 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: Trivalent inactivated influenza vaccine
Biological: Inactivated H1N1 Vaccine
Drug: Placebo

  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 adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 7AUG2009 and 28AUG2009.

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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Participant Flow:   Overall Study
    Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1
STARTED   202   200   203   200 
COMPLETED   200   198   197   198 
NOT COMPLETED   2   2   6   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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Total Total of all reporting groups

Baseline Measures
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1   Total 
Overall Participants Analyzed 
[Units: Participants]
 202   200   203   200   805 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   101   103   102   102   408 
>=65 years   101   97   101   98   397 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.2  (16.2)   58.4  (16.7)   58.5  (16.6)   59.1  (15.3)   58.8  (16.2) 
Gender 
[Units: Participants]
         
Female   99   118   104   123   444 
Male   103   82   99   77   361 
Region of Enrollment 
[Units: Participants]
         
United States   202   200   203   200   805 


  Outcome Measures
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1.  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 first H1N1 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. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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 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 at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 98   101   99   94 
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]
 90   87   91   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 21 Days Following the First Dose of H1N1 Vaccine



2.  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 first H1N1 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. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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 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 at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 101   97   101   95 
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]
 81   79   88   75 

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



3.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 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 180 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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   200   203   200 
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) 
[Units: Participants]
 0   0   0   0 

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



4.  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. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.
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 at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 98   101   99   94 
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]
 84   83   89   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 First Dose of H1N1 Vaccine



5.  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. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.
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 at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 101   97   101   95 
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]
 78   72   78   68 

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



6.  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, and nausea 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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   200   203   200 
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination 
[Units: Participants]
       
Feverishness   12   12   7   13 
Malaise   30   41   27   33 
Myalgia   23   24   16   23 
Headache   43   44   35   44 
Nausea   12   11   11   12 

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



7.  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, and nausea 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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 193   190   189   192 
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination 
[Units: Participants]
       
Feverishness   14   8   12   10 
Malaise   29   29   35   23 
Myalgia   18   14   19   14 
Headache   28   26   29   21 
Nausea   6   6   4   8 

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea 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 third 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 third vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 190   185   183   188 
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination 
[Units: Participants]
       
Feverishness   6   8   5   5 
Malaise   17   15   18   14 
Myalgia   10   12   11   6 
Headache   16   19   17   15 
Nausea   4   5   5   7 

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



9.  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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   200   202   200 
Number of Participants Reporting Fever After the First Vaccination 
[Units: Participants]
 0   1   0   0 

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



10.  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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 193   190   188   192 
Number of Participants Reporting Fever After the Second Vaccination 
[Units: Participants]
 0   2   0   3 

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Fever After the Third 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 third 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 third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 190   184   183   188 
Number of Participants Reporting Fever After the Third Vaccination 
[Units: Participants]
 0   0   1   0 

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



12.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.
Time Frame Within 8 days (Day 0-7) post first H1N1 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 H1N1 vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   200   203   192 
Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination 
[Units: Participants]
       
Pain   26   32   26   11 
Tenderness   45   46   47   29 
Swelling   18   14   16   20 

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination



13.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.
Time Frame Within 8 days (Day 0-7) post second H1N1 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 H1N1 vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 194   190   189   188 
Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination 
[Units: Participants]
       
Pain   28   22   30   19 
Tenderness   51   44   58   37 
Swelling   28   17   20   25 

No statistical analysis provided for Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the TIV 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.
Time Frame Within 8 days (Day 0-7) post TIV 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 TIV vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 190   200   189   200 
Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination 
[Units: Participants]
       
Pain   32   57   46   48 
Tenderness   71   93   80   84 
Swelling   27   27   22   28 

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo 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. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.
Time Frame Within 8 days (Day 0-7) post first placebo 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 placebo vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   190   203   200 
Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination 
[Units: Participants]
       
Pain   12   14   13   11 
Tenderness   21   14   21   21 
Swelling   12   18   12   14 

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo 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. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.
Time Frame Within 8 days (Day 0-7) post second placebo 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 placebo vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 194   185   183   192 
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination 
[Units: Participants]
       
Pain   11   9   5   8 
Tenderness   15   7   9   17 
Swelling   25   13   14   13 

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



17.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness 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 H1N1 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 H1N1 vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   200   203   192 
Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination 
[Units: Participants]
       
Redness   32   33   27   31 
Swelling   19   16   19   21 

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination



18.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness 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 H1N1 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 H1N1 vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 194   190   189   188 
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination 
[Units: Participants]
       
Redness   29   27   29   35 
Swelling   29   18   19   27 

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness 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 TIV 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 TIV vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 190   200   189   200 
Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination 
[Units: Participants]
       
Redness   31   40   30   37 
Swelling   28   27   21   28 

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness 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 placebo 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 placebo vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 202   190   203   200 
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination 
[Units: Participants]
       
Redness   34   19   21   37 
Swelling   12   20   12   28 

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness 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 placebo 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 placebo vaccination are included. Analyses are as treated.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 194   185   183   192 
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination 
[Units: Participants]
       
Redness   30   25   26   30 
Swelling   27   17   14   14 

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



22.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Measure Description Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.
Time Frame Day 63  
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 all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 91   89   88   90 
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination 
[Units: Participants]
       
TIV H1 antigen   46   40   38   39 
TIV H3 antigen   52   48   46   47 
TIV B antigen   34   31   36   39 

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination



23.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Measure Description Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.
Time Frame Day 63  
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 all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 92   87   90   91 
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination 
[Units: Participants]
       
TIV H1 antigen   66   62   53   57 
TIV H3 antigen   37   27   34   31 
TIV B antigen   14   14   20   18 

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination



24.  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. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.
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 at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 94   92   90   90 
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]
 85   77   85   75 

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



25.  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. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.
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 at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 96   92   93   91 
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]
 80   73   72   65 

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



26.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Measure Description Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.
Time Frame Day 63  
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 all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 91   89   88   90 
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination 
[Units: Participants]
       
TIV H1 antigen   79   77   78   81 
TIV H3 antigen   84   80   77   84 
TIV B antigen   81   75   78   81 

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination



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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Measure Description Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.
Time Frame Day 63  
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 all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 92   87   90   91 
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination 
[Units: Participants]
       
TIV H1 antigen   85   82   81   87 
TIV H3 antigen   86   80   83   77 
TIV B antigen   71   69   68   62 

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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination



28.  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 second H1N1 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 vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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 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 at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 94   92   90   90 
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]
 89   82   87   80 

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



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 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after second H1N1 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 vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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 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 at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
   Group 1: H1N1+Placebo; H1N1+Placebo; TIV   Group 2: H1N1+TIV; H1N1+Placebo; Placebo   Group 3: H1N1+Placebo; H1N1+TIV; Placebo   Group 4: TIV+Placebo; H1N1+Placebo; H1N1 
Participants Analyzed 
[Units: Participants]
 96   92   93   91 
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]
 83   78   81   71 

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




  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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