Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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  
Number of Participants  
[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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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  
Number of 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




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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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