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Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00107042
First received: April 4, 2005
Last updated: June 23, 2014
Last verified: April 2014
Results First Received: September 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Hepatitis B
Interventions: Biological: Recombivax
Biological: Twinrix

  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
The study was started in February 2004 and was completed in July 2008. A total of 11 sites, all in the United States and Puerto Rico, participated in the study.

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
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Participant Flow:   Overall Study
    Recombivax     Twinrix  
STARTED     60     63  
COMPLETED     38     47  
NOT COMPLETED     22     16  
Lost to Follow-up                 9                 7  
Withdrawal by Subject                 6                 1  
Moved out of area                 5                 3  
Pregnancy                 1                 1  
Inadvertent enrollment                 0                 1  
vaccinated outside window                 1                 1  
Disallowed medications                 0                 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
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24
Total Total of all reporting groups

Baseline Measures
    Recombivax     Twinrix     Total  
Number of Participants  
[units: participants]
  60     63     123  
Age  
[units: years]
Mean ± Standard Deviation
  15.02  ± 1.43     15.22  ± 1.71     15.12  ± 1.58  
Age, Customized  
[units: participants]
     
12 - 14 years     18     23     41  
15 - 17 years     42     40     82  
Gender  
[units: participants]
     
Female     19     27     46  
Male     41     36     77  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     20     14     34  
White     3     6     9  
More than one race     37     43     80  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Qualitative Seroresponsiveness to Hepatitis B Surface Antigen   [ Time Frame: Week (Wk) 28 (One month after the second immunization) ]

Measure Type Primary
Measure Title Qualitative Seroresponsiveness to Hepatitis B Surface Antigen
Measure Description

Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows:

Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL.

Time Frame Week (Wk) 28 (One month after the second immunization)  
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 were included if they were vaccinated at least once (Intent-to-Treat)

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  47     55  
Qualitative Seroresponsiveness to Hepatitis B Surface Antigen  
[units: Participants]
   
Responder     41     52  
Non-responder     6     3  


Statistical Analysis 1 for Qualitative Seroresponsiveness to Hepatitis B Surface Antigen
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.2954
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Qualitative Seroresponsiveness to Hepatitis B Surface Antigen
Groups [1] Recombivax
Method [2] 95% confidence interval
Response Rate [3] 87.23
95% Confidence Interval ( 74.26 to 95.17 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "Recombivax" arm is presented here.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Qualitative Seroresponsiveness to Hepatitis B Surface Antigen
Groups [1] Twinrix
Method [2] 95% confidence interval
Response Rate [3] 94.55
95% Confidence Interval ( 84.88 to 98.86 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "'Twinrix" arm is presented here.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



2.  Primary:   Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))   [ Time Frame: Week 12, Week 24, Week 28, Week 76 ]

Measure Type Primary
Measure Title Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))
Measure Description Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.
Time Frame Week 12, Week 24, Week 28, Week 76  
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.
The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  60     63  
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))  
[units: participants]
  6     4  

No statistical analysis provided for Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))



3.  Primary:   Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)   [ Time Frame: Week 12, Week 24, Week 28, Week 76 ]

Measure Type Primary
Measure Title Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)
Measure Description Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. The number of participants with at least one SAE is reported.
Time Frame Week 12, Week 24, Week 28, Week 76  
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.
The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  60     63  
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)  
[units: participants]
   
Asthenia     1     0  
Forearm fracture     1     0  
Road traffic accident     0     1  
Anxiety     0     1  

No statistical analysis provided for Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)



4.  Secondary:   Quantitative Vaccine Response   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Quantitative Vaccine Response
Measure Description The Log10 titer was used as the quantitative vaccine response.
Time Frame Week 28  
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.
Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  47     54  
Quantitative Vaccine Response  
[units: Log10 titer (mIU/ml)]
Mean ± Standard Deviation
  2.29  ± 0.82     2.58  ± 0.65  


Statistical Analysis 1 for Quantitative Vaccine Response
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.0608
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Quantitative Vaccine Response
Groups [1] Recombivax
Method [2] 95% confidence interval
Mean response [3] 2.29
95% Confidence Interval ( 2.05 to 2.53 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "Recombivax" arm is presented here.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Quantitative Vaccine Response
Groups [1] Twinrix
Method [2] 95% confidence interval
Response rate [3] 2.58
95% Confidence Interval ( 2.40 to 2.76 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Two-sided confidence intervals (CI) were calculated for both the "Recombivax" and "Twinrix" arms. The CI for the "Twinrix" arm is presented here.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



5.  Secondary:   Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Measure Description The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.
Time Frame Week 28  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).

Reporting Groups
  Description
All Participants All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  75  
Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.  
[units: Participant]
 
Study Arm: Recombivax     34  
Study Arm: Twinrix     41  
Site Effect: Other Site     43  
Site Effect: Baltimore     32  
Age: 15 - 17 years     51  
Age: 12 - 14 years     24  
Gender: Female     29  
Gender: Male     46  
Hispanic Ethnicity: No     23  
Hispanic Ethnicity: Yes     52  
Racial Background: White     6  
Racial Background: Other/Mixed Race     47  
Racial Background: Black/African American     22  
Tanner Stage for Females: Stage 5     17  
Tanner Stage for Females: Stages 1 - 4     12  
Tanner Stage for Males: Stage 5     15  
Tanner Stage for Males: Stages 1 - 4     31  
BMI at Baseline: Normal and Underweight (<25.0)     49  
BMI at Baseline: Overweight and Obese (>=25.0)     26  
Ever Smoked Cigarettes: No     59  
Ever Smoked Cigarettes: Yes     16  
Sexual Identity: Straight (Heterosexual)     67  
Sexual Identity: Gay, Bi, Not Sure or Undecided     8  
Age First Sex Not Forced: Never     44  
Age First Sex Not Forced: <=14 Years     8  
Age First Sex Not Forced: 15-17 Years     17  
Total Lifetime Sex Partners: 0 Partners     44  
Total Lifetime Sex Partners: 1-5 Partners     19  
Total Lifetime Sex Partners: >= 6 Partners     10  
Total Lifetime Male Sex Partners: 0 Partners     58  
Total Lifetime Male Sex Partners: 1-5 Partners     10  
Total Lifetime Male Sex Partners: >= 6 Partners     5  
Total Lifetime Female Sex Partners: 0 Partners     57  
Total Lifetime Female Sex Partners: 1-5 Partners     11  
Total Lifetime Female Sex Partners: >= 6 Partners     5  
Ever Drank Alcohol: No     45  
Ever Drank Alcohol: Yes     30  
Ever Smoked Marijuana: No     58  
Ever Smoked Marijuana: Yes     17  
Ever Used Drugs not Prescribed: No     71  
Ever Used Drugs not Prescribed: Yes     4  


Statistical Analysis 1 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.1667
Regression coefficient [4] 0.2455
Standard Error of the mean ± 0.1757
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.9890
Regression coefficent [4] -0.0025
Standard Error of the mean ± 0.1792
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.2796
Regression coeffcient [4] 0.2053
Standard Error of the mean ± 0.1885
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0080
Regresssion coeffcient [4] -0.4726
Standard Error of the mean ± 0.1734
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.2543
Regression coefficient [4] 0.2189
Standard Error of the mean ± 0.1905
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.3661
Regression coefficient [4] 0.2994
Standard Error of the mean ± 0.3292
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.9812
Regression coefficient [4] 0.0083
Standard Error of the mean ± 0.3497
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.7766
Regression coefficient [4] -0.0663
Standard Error of the mean ± 0.2314
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.2492
Regression coefficient [4] -0.2929
Standard Error of the mean ± 0.2508
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0877
Regression coeffcient [4] -0.3160
Standard Error of the mean ± 0.1826
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (<25.0) vs. Overweight and Obsese (>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0117
Regression coefficient [4] -0.0292
Standard Error of the mean ± 0.0113
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 12 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.7899
Regression coefficient [4] -0.0578
Standard Error of the mean ± 0.2163
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 13 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0607
Regression coefficient [4] -0.5339
Standard Error of the mean ± 0.2803
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 14 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.1670
Regression coefficient [4] -0.3883
Standard Error of the mean ± 0.2779
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. <= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between "never" vs. "<= 14 year olds" is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 15 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.8682
Regression coefficient [4] 0.0344
Standard Error of the mean ± 0.2065
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. <= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between "never" vs. "15-17 year olds" is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 16 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.4219
Regression coefficient [4] 0.1532
Standard Error of the mean ± 0.1896
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 17 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0020
Regression coefficient [4] -0.7752
Standard Error of the mean ± 0.2420
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 18 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.1659
Regression coefficient [4] 0.2921
Standard Error of the mean ± 0.2086
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 19 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0000
Regression coefficient [4] -1.6163
Standard Error of the mean ± 0.2839
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 20 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.4701
Regression coefficient [4] -0.1788
Standard Error of the mean ± 0.2463
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 21 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.7572
Regression coefficient [4] 0.1083
Standard Error of the mean ± 0.3488
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 22 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.8657
Regression coefficient [4] -0.0307
Standard Error of the mean ± 0.1809
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 23 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0917
Regression coefficient [4] -0.3548
Standard Error of the mean ± 0.2076
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 24 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.3788
Regression coefficient [4] -0.3474
Standard Error of the mean ± 0.3924
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.
Measure Description Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  47     55  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.  
[units: Participants]
   
Responder     41     52  
Non-Responder     6     3  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.2068
Odds Ratio (OR) [4] 2.54
95% Confidence Interval ( 0.60 to 10.76 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'Recombivax' group.



7.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT
Measure Description Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum antibody level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Other Sites All other clinical sites (besides the Baltimore site) where subjects were enrolled.
Baltimore Clinical site where subjects were enrolled.

Measured Values
    Other Sites     Baltimore  
Number of Participants Analyzed  
[units: participants]
  47     55  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT  
[units: Participants]
   
Responder     42     51  
Non-Responder     5     4  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.5524
Odds Ratio (OR) [4] 1.52
95% Confidence Interval ( 0.38 to 6.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'Other Sites' group.



8.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
15-17 Years of Age Subjects between the ages of 15 and 17 years, inclusive
12-14 Years of Age Subjects between the ages of 12 and 14 years, inclusive

Measured Values
    15-17 Years of Age     12-14 Years of Age  
Number of Participants Analyzed  
[units: participants]
  68     34  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE  
[units: Participants]
   
Responder     61     32  
Non-Responder     7     2  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.4646
Odds Ratio (OR) [4] 1.84
95% Confidence Interval ( 0.36 to 9.36 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the '15-17 year' age group



9.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Female Female Subjects
Male Male Subjects

Measured Values
    Female     Male  
Number of Participants Analyzed  
[units: participants]
  38     64  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER  
[units: Participants]
   
Responder     36     57  
Non-Responder     2     7  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.3390
Odds Ratio (OR) [4] 0.45
95% Confidence Interval ( 0.09 to 2.30 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'Female' group.



10.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Not Hispanic Subjects who reported they were not of Hispanic ethnicity.
Hispanic Subjects who reported they were of Hispanic ethnicity.

Measured Values
    Not Hispanic     Hispanic  
Number of Participants Analyzed  
[units: participants]
  27     75  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY  
[units: Participants]
   
Responder     21     72  
Non-Responder     6     3  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.0102
Odds Ratio (OR) [4] 6.86
95% Confidence Interval ( 1.58 to 29.78 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'Hispanic: NO' group.

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY
Groups [1] All groups
Method [2] Multivariate regression, logistic
P Value [3] 0.0118
Odds Ratio (OR) [4] 7.38
95% Confidence Interval ( 1.56 to 34.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Since Hispanic (no, yes) was a factor with a p-value of < 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.
[4] Other relevant estimation information:
  The reference group is the "Hispanic: NO" group.



11.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.

Reporting Groups
  Description
White Subjects who reported their race to be white.
Other/Mixed Race Subjects who reported their race to be other than white, black, or of mixed race.
Black/African American Subjects who reported their race to be black or African American

Measured Values
    White     Other/Mixed Race     Black/African American  
Number of Participants Analyzed  
[units: participants]
  9     68     25  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE  
[units: Participants]
     
Responder     8     66     19  
Non-Responder     1     2     6  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE
Groups [1] White vs. Black/African American
Method [2] Univariate regression, logistic
P Value [3] 0.4241
Odds Ratio (OR) [4] 0.40
95% Confidence Interval ( 0.04 to 3.84 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'White' group.

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE
Groups [1] White vs. Other/Mixed Race
Method [2] Univariate regression, logistic
P Value [3] 0.2685
Odds Ratio (OR) [4] 4.12
95% Confidence Interval ( 0.34 to 50.76 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'White' group.



12.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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.
Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Tanner Stage 5 (Females) Females who were self-assessed and categorized to Tanner Stage 5.
Tanner Stages 1-4 (Females) Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.

Measured Values
    Tanner Stage 5 (Females)     Tanner Stages 1-4 (Females)  
Number of Participants Analyzed  
[units: participants]
  20     18  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES  
[units: Participants]
   
Responder     19     17  
Non-responder     1     1  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.9390
Odds Ratio (OR) [4] 0.89
95% Confidence Interval ( 0.05 to 15.44 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the 'Stage 5' group.



13.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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.
Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.

Reporting Groups
  Description
Tanner Stage 5 (Males) Males who were self-assessed and categorized to Tanner Stage 5.
Tanner Stages 1-4 (Males) Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.

Measured Values
    Tanner Stage 5 (Males)     Tanner Stages 1-4 (Males)  
Number of Participants Analyzed  
[units: participants]
  22     42  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES  
[units: Participants]
   
Responder     19     38  
Non-responder     3     4  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.6181
Odds Ratio (OR) [4] 1.50
95% Confidence Interval ( 0.30 to 7.39 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Stage 5" group.



14.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Normal and Underweight (< 25.0) Subjects whose BMIs were normal to < 25.0
Overweight and Obese (>=25.0) Subjects whose BMIs were >= 25.0

Measured Values
    Normal and Underweight (< 25.0)     Overweight and Obese (>=25.0)  
Number of Participants Analyzed  
[units: participants]
  66     36  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline  
[units: Participants]
   
Responder     62     31  
Non-responder     4     5  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.1943
Odds Ratio (OR) [4] 0.40
95% Confidence Interval ( 0.10 to 1.60 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Normal and Underweight (<25.0)" group.



15.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Ever Smoked Cigarettes: NO Subjects who have never smoked cigarettes
Ever Smoked Cigarettes: YES Subjects who have smoked cigarettes

Measured Values
    Ever Smoked Cigarettes: NO     Ever Smoked Cigarettes: YES  
Number of Participants Analyzed  
[units: participants]
  82     19  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES  
[units: Participants]
   
Responder     76     16  
Non-responder     6     3  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.2542
Odds Ratio (OR) [4] 0.42
95% Confidence Interval ( 0.10 to 1.86 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Ever smoked cigarettes: NO" group.



16.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Straight (Heterosexual) Subjects who were straight (heterosexual)
Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided Subjects who were either gay (homosexual), bisexual, not sure or undecided.

Measured Values
    Straight (Heterosexual)     Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided  
Number of Participants Analyzed  
[units: participants]
  93     9  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY  
[units: Participants]
   
Responder     87     6  
Non-responder     6     3  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.0161
Odds Ratio (OR) [4] 0.14
95% Confidence Interval ( 0.03 to 0.69 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Straight (heterosexual)" group.

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY
Groups [1] All groups
Method [2] Multivariate regression, logistic
P Value [3] 0.0222
Odds Ratio (OR) [4] 0.12
95% Confidence Interval ( 0.02 to 0.74 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Since sexual identity was a factor with a p-value of < 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.
[4] Other relevant estimation information:
  The reference group is the "Straight (heterosexual)" group.



17.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age of participants’ first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Never Subjects who reported they never had anal or vaginal sex because they wanted to.
12-14 Years of Age Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
15-17 Years of Age Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive

Measured Values
    Never     12-14 Years of Age     15-17 Years of Age  
Number of Participants Analyzed  
[units: participants]
  62     10     24  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)  
[units: Participants]
     
Responder     59     7     23  
Non-responder     3     3     1  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)
Groups [1] Never vs. 15-17 Years of Age
Method [2] Univariate regression, logistic
P Value [3] 0.8945
Odds Ratio (OR) [4] 1.17
95% Confidence Interval ( 0.12 to 11.83 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Never" (had sex)group.

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)
Groups [1] Never vs. 12-14 Years of Age
Method [2] Univariate regression, logistic
P Value [3] 0.0190
Odds Ratio (OR) [4] 0.12
95% Confidence Interval ( 0.02 to 0.70 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Never" (had sex) group.



18.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
0 Sex Partners Subjects who have never had a sex partner
1 - 5 Sex Partners Subjects who have had 1 - 5 lifetime sex partners
>= 6 Sex Partners Subjects who have had 6 or more lifetime sex partners

Measured Values
    0 Sex Partners     1 - 5 Sex Partners     >= 6 Sex Partners  
Number of Participants Analyzed  
[units: participants]
  62     26     12  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS  
[units: Participants]
     
Responder     59     26     7  
Non-responder     3     0     5  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS
Groups [1] 0 Sex Partners vs. >= 6 Sex Partners
Method [2] Univariate regression, logistic
P Value [3] 0.0042
Odds Ratio (OR) [4] 0.08
95% Confidence Interval ( 0.01 to 0.48 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "0 partners" group

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS
Groups [1] 0 Sex Partners vs. 1 - 5 Sex Partners
Method [2] Univariate regression, Logistic
P Value [3] 0.6893
Odds Ratio (OR) [4] 1.65
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
 

The reference group is the "0 partners" group.

Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity




19.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
0 Male Sex Partners Male and female subjects who have never had a male sex partner
1-5 Male Sex Partners Male and female subjects who have had 1 - 5 lifetime male sex partners
>= 6 Male Sex Partners Male and female subjects who have had 6 or more lifetime male sex partners

Measured Values
    0 Male Sex Partners     1-5 Male Sex Partners     >= 6 Male Sex Partners  
Number of Participants Analyzed  
[units: participants]
  82     13     5  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS  
[units: Participants]
     
Responder     78     13     1  
Non-responder     4     0     4  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS
Groups [1] 0 Male Sex Partners vs. >= 6 Male Sex Partners
Method [2] Univariate regression, logistic
P Value [3] 0.0003
Odds Ratio (OR) [4] 0.015
95% Confidence Interval ( 0.00 to 0.19 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is hte "0 Partners" group.

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS
Groups [1] 0 Male Sex Partners vs. 1-5 Male Sex Partners
Method [2] Univariate regression, Logistic
P Value [3] 1.0000
Odds Ratio (OR) [4] 1.18
95% Confidence Interval ( 0.00 to 10.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "0 Partners" group



20.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
0 Female Sex Partners Male and female subjects who have never had a female sex partner
1-5 Female Sex Partners Male and female Subjects who have had 1 - 5 lifetime female sex partners
>= 6 Female Sex Partners Male and female subjects who have had 6 or more lifetime female sex partners

Measured Values
    0 Female Sex Partners     1-5 Female Sex Partners     >= 6 Female Sex Partners  
Number of Participants Analyzed  
[units: participants]
  78     15     7  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS  
[units: Participants]
     
Responder     72     14     6  
Non-responder     6     1     1  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS
Groups [1] 0 Female Sex Partners vs. >= 6 Female Sex Partners
Method [2] Univariate regression, logistic
P Value [3] 0.5503
Odds Ratio (OR) [4] 0.50
95% Confidence Interval ( 0.05 to 4.86 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "0 Partners" group

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS
Groups [1] 0 Female Sex Partners vs. 1-5 Female Sex Partners
Method [2] Univariate Regression, Logistic
P Value [3] 0.8904
Odds Ratio (OR) [4] 1.17
95% Confidence Interval ( 0.13 to 10.46 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "0 Partners" group.



21.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Ever Drank Alcohol: NO Subjects who have never drank alcohol
Ever Drank Alcohol: YES Subjects who have drank alcohol

Measured Values
    Ever Drank Alcohol: NO     Ever Drank Alcohol: YES  
Number of Participants Analyzed  
[units: participants]
  62     40  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL  
[units: Participants]
   
Responder     58     35  
Non-responder     4     5  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.3010
Odds Ratio (OR) [4] 0.48
95% Confidence Interval ( 0.12 to 1.92 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Ever drank alcohol: NO" group.



22.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Ever Smoked Marijuana: NO Subjects who have never smoked marijuana
Ever Smoked Marijuana: YES Subjects who have smoked marijuana

Measured Values
    Ever Smoked Marijuana: NO     Ever Smoked Marijuana: YES  
Number of Participants Analyzed  
[units: participants]
  83     19  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA  
[units: Participants]
   
Responder     78     15  
Non-responder     5     4  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.0501
Odds Ratio (OR) [4] 0.24
95% Confidence Interval ( 0.06 to 1.00 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Ever smoked marijuana: NO" group.



23.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
Time Frame Week 28  
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 had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
Ever Used Drugs Not Prescribed: NO Subjects who have never used drugs that were not prescribed.
Ever Used Drugs Not Prescribed: YES Subjects who have used drugs that were not prescribed.

Measured Values
    Ever Used Drugs Not Prescribed: NO     Ever Used Drugs Not Prescribed: YES  
Number of Participants Analyzed  
[units: participants]
  97     5  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE  
[units: Participants]
   
Responder     89     4  
Non-responder     8     1  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.3846
Odds Ratio (OR) [4] 0.36
95% Confidence Interval ( 0.04 to 3.61 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  The reference group is the "Ever used drugs not prescribed: NO" group.



24.  Secondary:   Immunogenicity to Hep B 18 Months After First Immunization   [ Time Frame: Week 76 ]

Measure Type Secondary
Measure Title Immunogenicity to Hep B 18 Months After First Immunization
Measure Description Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76
Time Frame Week 76  
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 had a week 76 Hepatitis B antibody titer were included in this analysis.

One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer.


Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  37     50  
Immunogenicity to Hep B 18 Months After First Immunization  
[units: Participants]
   
Responded (>= 10mIU/ml)     30     44  
Not responded (< 10mIU/ml)     7     6  


Statistical Analysis 1 for Immunogenicity to Hep B 18 Months After First Immunization
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.3827
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Immunogenicity to Hep B 18 Months After First Immunization
Groups [1] Recombivax
Responding Rate [2] 81.08
95% Confidence Interval ( 68.84 to 92.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Response rate=Total number subjects responded/Total number subjects in arm

Statistical Analysis 3 for Immunogenicity to Hep B 18 Months After First Immunization
Groups [1] Twinrix
Responding Rate [2] 88.0
95% Confidence Interval ( 75.69 to 95.47 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Response rate=Total number subjects responded/Total number subjects in arm



25.  Secondary:   Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination
Measure Description Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.
Time Frame Week 28  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.

Reporting Groups
  Description
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Twinrix  
Number of Participants Analyzed  
[units: participants]
  52  
Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination  
[units: percentage of participants]
 
POSITIVE (1 month post 2nd vaccination)     98.08  
NEGATIVE (1 month post 2nd vaccination)     1.92  


Statistical Analysis 1 for Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination
Groups [1] Twinrix
Method [2] Exact 95% CI
Responding rate [3] 98.08
95% Confidence Interval ( 89.74 to 99.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



26.  Secondary:   Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination   [ Time Frame: Week 76 ]

Measure Type Secondary
Measure Title Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination
Measure Description Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.
Time Frame Week 76  
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.
Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.

Reporting Groups
  Description
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Twinrix  
Number of Participants Analyzed  
[units: participants]
  47  
Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination  
[units: percentage of participants]
 
Positive (12 months post 2nd vaccination)     91.49  
Negative (12 months post 2nd vaccination)     8.51  


Statistical Analysis 1 for Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination
Groups [1] Twinrix
Method [2] Exact 95 % confidence interval
Responding Rate [3] 91.49
95% Confidence Interval ( 79.62 to 97.63 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



27.  Secondary:   Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)   [ Time Frame: Week 28 and Week 76 ]

Measure Type Secondary
Measure Title Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)
Measure Description Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.
Time Frame Week 28 and Week 76  
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.
Subjects in the Twinrix arm who had week 28 &/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered “Positive”. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was “Negative”.

Reporting Groups
  Description
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Twinrix  
Number of Participants Analyzed  
[units: participants]
  53  
Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)  
[units: percentage of participants]
 
Positive: overall     98.11  
Negative: overall     1.89  


Statistical Analysis 1 for Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)
Groups [1] Twinrix
Method [2] Exact 95% confidence interval
Responding Rate % [3] 98.11
95% Confidence Interval ( 89.93 to 99.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered “Positive”. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is “Negative”.



28.  Secondary:   As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen   [ Time Frame: Week 28 ]

Measure Type Secondary
Measure Title As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen
Measure Description The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.
Time Frame Week 28  
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.
Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  41     47  
As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen  
[units: percentage of participants]
   
Responded (>=10mIU/ml)     85.4     93.6  
Not responded (< 10mIU/ml)     14.6     6.4  


Statistical Analysis 1 for As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.2938
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen
Groups [1] Recombivax
Method [2] 95 % confidence interval
Responding Rate % [3] 85.37
95% Confidence Interval ( 70.83 to 94.43 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen
Groups [1] Twinrix
Method [2] 95% confidence interval
Responding Rate % [3] 93.62
95% Confidence Interval ( 82.46 to 98.66 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



29.  Secondary:   Assessment of Youth Understanding of Vaccine Trial and Informed Consent   [ Time Frame: Screening ]

Measure Type Secondary
Measure Title Assessment of Youth Understanding of Vaccine Trial and Informed Consent
Measure Description Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.
Time Frame Screening  
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.
No text entered.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Measured Values
    Recombivax     Twinrix  
Number of Participants Analyzed  
[units: participants]
  60     63  
Assessment of Youth Understanding of Vaccine Trial and Informed Consent  
[units: Number of correct answers]
Mean ± Standard Deviation
  5.18  ± 1.24     5.1  ± 1.32  

No statistical analysis provided for Assessment of Youth Understanding of Vaccine Trial and Informed Consent




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  Other Adverse Events


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