H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992433
First received: October 8, 2009
Last updated: May 10, 2012
Last verified: February 2011
Results First Received: October 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Inactivated Influenza H1N1 vaccine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were HIV-positive adult males and females recruited from existing patient populations and from the communities at large around the clinical sites. Participants were enrolled between 19Nov2009 and 23Apr2010.

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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Participant Flow:   Overall Study
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
STARTED     95     97  
COMPLETED     91     90  
NOT COMPLETED     4     7  



  Baseline Characteristics
  Hide Baseline Characteristics

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

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine     Total  
Number of Participants  
[units: participants]
  95     97     192  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     95     97     192  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.7  ± 9.9     45.3  ± 9.3     45.5  ± 9.6  
Gender  
[units: participants]
     
Female     19     22     41  
Male     76     75     151  
Region of Enrollment  
[units: participants]
     
United States     95     97     192  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 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 10 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 10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 10 days after the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     34  
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  14     23  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine



2.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum 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 vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the first 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 not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     32  
Number of Participants in the CD4 Less Than 200/mL Stratum 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]
  14     21  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine



3.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 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 10 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 10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 10 days after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     33  
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  15     23  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine



4.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum 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 vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the second 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 in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     32  
Number of Participants in the CD4 Less Than 200/mL Stratum 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]
  18     19  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum 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



5.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 180 days after the second 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 in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  33     32  
Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  9     13  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



6.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 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 10 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 10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 10 days after the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  60     58  
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  32     42  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine



7.  Primary:   Number of Participants in the CD4 CD4 200/mL or Greater Stratum 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 vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the first 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. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  58     60  
Number of Participants in the CD4 CD4 200/mL or Greater Stratum 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]
  30     42  

No statistical analysis provided for Number of Participants in the CD4 CD4 200/mL or Greater Stratum 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



8.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 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 10 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 10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 10 days after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  55     57  
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  32     41  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine



9.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum 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 vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 21 days after the second 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 in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  55     57  
Number of Participants in the CD4 200/mL or Greater Stratum 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]
  30     40  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum 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



10.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 180 days after the second 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 in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  54     55  
Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  16     27  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



11.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 0 prior to vaccination and 10 days after the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     34  
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
   
Day 0     7     8  
Day 10     16     24  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine



12.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum 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 the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     32  
Number of Participants in the CD4 Less Than 200/mL Stratum 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]
  16     22  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum 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



13.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 10 after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 10 after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     33  
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  17     24  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine



14.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum 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 the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  34     32  
Number of Participants in the CD4 Less Than 200/mL Stratum 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]
  20     22  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum 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



15.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 180 after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  33     32  
Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  12     19  

No statistical analysis provided for Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



16.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 0 prior to the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  60     61  
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine  
[units: Participants]
  11     11  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine



17.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 10 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 10 after the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  60     58  
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine  
[units: Participants]
  40     45  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine



18.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum 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 the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after the first vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  58     60  
Number of Participants in the CD4 200/mL or Greater Stratum 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]
  37     45  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum 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



19.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 10 and Day 21 after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 10 and Day 21 after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  55     57  
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
   
Day 10 Post Second Dose     38     43  
Day 21 Post Second Dose     36     42  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine



20.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

Measure Type Primary
Measure Title Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 180 after the second vaccination  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  54     55  
Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  25     32  

No statistical analysis provided for Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine



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

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 post first vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  95     97  
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination  
[units: Participants]
   
Feverishness     11     6  
Malaise     22     20  
Myalgia     14     20  
Headache     24     26  
Nausea     12     9  

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



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

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 post second vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  89     94  
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination  
[units: Participants]
   
Feverishness     8     10  
Malaise     14     14  
Myalgia     14     14  
Headache     11     20  
Nausea     7     9  

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



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

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 post first vaccination (Day 0-7).  
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. One participant did not record temperatures. Analyses are as treated.

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  95     96  
Number of Participants Reporting Fever After the First Vaccination  
[units: Participants]
  0     1  

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



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

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 post second vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  89     94  
Number of Participants Reporting Fever After the Second Vaccination  
[units: Participants]
  1     2  

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days post first vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  95     97  
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination  
[units: Participants]
   
Pain     14     22  
Tenderness     19     31  
Swelling     9     7  

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time Frame Within 8 days post second vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  89     94  
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination  
[units: Participants]
   
Pain     8     16  
Tenderness     11     25  
Swelling     8     6  

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of 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 post first vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  95     97  
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination  
[units: Participants]
   
Redness     12     13  
Swelling     9     7  

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



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

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of 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 post second vaccination (Day 0-7).  
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  89     94  
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination  
[units: Participants]
   
Redness     12     8  
Swelling     9     6  

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



29.  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 diagnosis.
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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  95     97  
Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)  
[units: Participants]
  0     0  

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




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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