Trial Outcomes & Findings for Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths (NCT NCT00107042)

Last Updated: 2017-03-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

Week (Wk) 28 (One month after the second immunization)

Results posted on

2017-03-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	60	63
Overall Study COMPLETED	38	47
Overall Study NOT COMPLETED	22	16

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	9	7
Overall Study Withdrawal by Subject	6	1
Overall Study Moved out of area	5	3
Overall Study Pregnancy	1	1
Overall Study Inadvertent enrollment	0	1
Overall Study vaccinated outside window	1	1
Overall Study Disallowed medications	0	2

Baseline Characteristics

Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombivax n=60 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=63 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Total n=123 Participants Total of all reporting groups
Age, Continuous	15.02 years STANDARD_DEVIATION 1.43 • n=5 Participants	15.22 years STANDARD_DEVIATION 1.71 • n=7 Participants	15.12 years STANDARD_DEVIATION 1.58 • n=5 Participants
Age, Customized 12 - 14 years	18 participants n=5 Participants	23 participants n=7 Participants	41 participants n=5 Participants
Age, Customized 15 - 17 years	42 participants n=5 Participants	40 participants n=7 Participants	82 participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	37 Participants n=5 Participants	43 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week (Wk) 28 (One month after the second immunization)

Population: Participants were included if they were vaccinated at least once (Intent-to-Treat)

Outcome measures

Outcome measures
Measure	Recombivax n=47 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=55 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Qualitative Seroresponsiveness to Hepatitis B Surface Antigen Responder	41 Participants	52 Participants	—
Qualitative Seroresponsiveness to Hepatitis B Surface Antigen Non-responder	6 Participants	3 Participants	—

PRIMARY outcome

Timeframe: Week 12, Week 24, Week 28, Week 76

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=60 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=63 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))	6 participants	4 participants	—

PRIMARY outcome

Timeframe: Week 12, Week 24, Week 28, Week 76

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=60 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=63 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) Asthenia	1 participants	0 participants	—
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) Forearm fracture	1 participants	0 participants	—
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) Anxiety	0 participants	1 participants	—
Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE) Road traffic accident	0 participants	1 participants	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

The Log10 titer was used as the quantitative vaccine response.

Outcome measures

Outcome measures
Measure	Recombivax n=47 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=54 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Quantitative Vaccine Response	2.29 Log10 titer (mIU/ml) Standard Deviation 0.82	2.58 Log10 titer (mIU/ml) Standard Deviation 0.65	—

SECONDARY outcome

Timeframe: Week 28

Population: 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).

The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.

Outcome measures

Outcome measures
Measure	Recombivax n=75 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
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. Study Arm: Recombivax	34 Participant	—	—
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. Study Arm: Twinrix	41 Participant	—	—
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. Site Effect: Other Site	43 Participant	—	—
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. Site Effect: Baltimore	32 Participant	—	—
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. Age: 15 - 17 years	51 Participant	—	—
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. Age: 12 - 14 years	24 Participant	—	—
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. Gender: Female	29 Participant	—	—
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. Gender: Male	46 Participant	—	—
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. Hispanic Ethnicity: No	23 Participant	—	—
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. Hispanic Ethnicity: Yes	52 Participant	—	—
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. Racial Background: White	6 Participant	—	—
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. Racial Background: Other/Mixed Race	47 Participant	—	—
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. Racial Background: Black/African American	22 Participant	—	—
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. Tanner Stage for Females: Stage 5	17 Participant	—	—
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. Tanner Stage for Females: Stages 1 - 4	12 Participant	—	—
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. Tanner Stage for Males: Stage 5	15 Participant	—	—
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. Tanner Stage for Males: Stages 1 - 4	31 Participant	—	—
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. BMI at Baseline: Normal and Underweight (<25.0)	49 Participant	—	—
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. BMI at Baseline: Overweight and Obese (>=25.0)	26 Participant	—	—
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. Ever Smoked Cigarettes: Yes	16 Participant	—	—
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. Sexual Identity: Straight (Heterosexual)	67 Participant	—	—
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. Sexual Identity: Gay, Bi, Not Sure or Undecided	8 Participant	—	—
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. Age First Sex Not Forced: Never	44 Participant	—	—
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. Age First Sex Not Forced: <=14 Years	8 Participant	—	—
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. Age First Sex Not Forced: 15-17 Years	17 Participant	—	—
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. Total Lifetime Sex Partners: 0 Partners	44 Participant	—	—
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. Total Lifetime Sex Partners: 1-5 Partners	19 Participant	—	—
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. Total Lifetime Sex Partners: >= 6 Partners	10 Participant	—	—
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. Total Lifetime Male Sex Partners: 0 Partners	58 Participant	—	—
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. Total Lifetime Male Sex Partners: 1-5 Partners	10 Participant	—	—
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. Total Lifetime Male Sex Partners: >= 6 Partners	5 Participant	—	—
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. Total Lifetime Female Sex Partners: 0 Partners	57 Participant	—	—
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. Total Lifetime Female Sex Partners: 1-5 Partners	11 Participant	—	—
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. Total Lifetime Female Sex Partners: >= 6 Partners	5 Participant	—	—
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. Ever Drank Alcohol: No	45 Participant	—	—
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. Ever Drank Alcohol: Yes	30 Participant	—	—
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. Ever Smoked Marijuana: No	58 Participant	—	—
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. Ever Smoked Marijuana: Yes	17 Participant	—	—
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. Ever Used Drugs not Prescribed: No	71 Participant	—	—
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. Ever Used Drugs not Prescribed: Yes	4 Participant	—	—
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. Ever Smoked Cigarettes: No	59 Participant	—	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=47 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=55 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. Responder	41 Participants	52 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM. Non-Responder	6 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=47 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=55 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT Responder	42 Participants	51 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT Non-Responder	5 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=68 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=34 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE Responder	61 Participants	32 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE Non-Responder	7 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=38 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=64 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER Responder	36 Participants	57 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER Non-Responder	2 Participants	7 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=27 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=75 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY Responder	21 Participants	72 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY Non-Responder	6 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=9 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=68 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American n=25 Participants Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE Responder	8 Participants	66 Participants	19 Participants
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE Non-Responder	1 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=20 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=18 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES Responder	19 Participants	17 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES Non-responder	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=22 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=42 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES Responder	19 Participants	38 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES Non-responder	3 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=66 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=36 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline Responder	62 Participants	31 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline Non-responder	4 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=82 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=19 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES Responder	76 Participants	16 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES Non-responder	6 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=93 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=9 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY Responder	87 Participants	6 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY Non-responder	6 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=62 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=10 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American n=24 Participants Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) Responder	59 Participants	7 Participants	23 Participants
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED) Non-responder	3 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=62 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=26 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American n=12 Participants Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS Responder	59 Participants	26 Participants	7 Participants
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS Non-responder	3 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=82 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=13 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American n=5 Participants Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS Responder	78 Participants	13 Participants	1 Participants
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS Non-responder	4 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=78 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=15 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American n=7 Participants Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS Responder	72 Participants	14 Participants	6 Participants
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS Non-responder	6 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=62 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=40 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL Responder	58 Participants	35 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL Non-responder	4 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=83 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=19 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA Responder	78 Participants	15 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA Non-responder	5 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Week 28

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.

Outcome measures

Outcome measures
Measure	Recombivax n=97 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=5 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE Responder	89 Participants	4 Participants	—
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE Non-responder	8 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Week 76

Population: 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.

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

Outcome measures

Outcome measures
Measure	Recombivax n=37 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=50 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Immunogenicity to Hep B 18 Months After First Immunization Responded (>= 10mIU/ml)	30 Participants	44 Participants	—
Immunogenicity to Hep B 18 Months After First Immunization Not responded (< 10mIU/ml)	7 Participants	6 Participants	—

SECONDARY outcome

Timeframe: Week 28

Population: The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=52 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination POSITIVE (1 month post 2nd vaccination)	98.08 percentage of participants	—	—
Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination NEGATIVE (1 month post 2nd vaccination)	1.92 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 76

Population: Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=47 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination Positive (12 months post 2nd vaccination)	91.49 percentage of participants	—	—
Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination Negative (12 months post 2nd vaccination)	8.51 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 28 and Week 76

Population: 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".

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.

Outcome measures

Outcome measures
Measure	Recombivax n=53 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination) Positive: overall	98.11 percentage of participants	—	—
Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination) Negative: overall	1.89 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 28

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Recombivax n=41 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=47 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen Responded (>=10mIU/ml)	85.4 percentage of participants	93.6 percentage of participants	—
As Treated Analysis - Adequate Antibody Response to Hep B Surface Antigen Not responded (< 10mIU/ml)	14.6 percentage of participants	6.4 percentage of participants	—

SECONDARY outcome

Timeframe: Screening

Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.

Outcome measures

Outcome measures
Measure	Recombivax n=60 Participants Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=63 Participants Experimental: 1st dose at Week 0, 2nd dose at Week 24	Black/African American Subjects who reported their race to be black or African American
Assessment of Youth Understanding of Vaccine Trial and Informed Consent	5.18 Number of correct answers Standard Deviation 1.24	5.1 Number of correct answers Standard Deviation 1.32	—

Adverse Events

Recombivax

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Twinrix

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Recombivax n=60 participants at risk Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=63 participants at risk Experimental: 1st dose at Week 0, 2nd dose at Week 24
General disorders Asthenia	1.7% 1/60 • Number of events 1	0.00% 0/63
Injury, poisoning and procedural complications Forearm Fracture	1.7% 1/60 • Number of events 1	0.00% 0/63
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/60	1.6% 1/63 • Number of events 1
Psychiatric disorders Anxiety	0.00% 0/60	1.6% 1/63 • Number of events 1

Other adverse events

Other adverse events
Measure	Recombivax n=60 participants at risk Active Comparator: 1st dose at Week 0, 2nd dose at Week 24	Twinrix n=63 participants at risk Experimental: 1st dose at Week 0, 2nd dose at Week 24
Gastrointestinal disorders Nausea	1.7% 1/60 • Number of events 3	0.00% 0/63
General disorders Asthenia	1.7% 1/60 • Number of events 3	0.00% 0/63
General disorders Chest Pain	0.00% 0/60	1.6% 1/63 • Number of events 1
General disorders Fatigue	1.7% 1/60 • Number of events 3	0.00% 0/63
General disorders Malaise	1.7% 1/60 • Number of events 3	0.00% 0/63
General disorders Pain NOS	1.7% 1/60 • Number of events 2	0.00% 0/63
Infections and infestations Dengue Fever	0.00% 0/60	1.6% 1/63 • Number of events 1
Infections and infestations Upper Respiratory Tract Infection NOS	0.00% 0/60	1.6% 1/63 • Number of events 1
Injury, poisoning and procedural complications Femure Fracture	0.00% 0/60	1.6% 1/63 • Number of events 1
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/60	1.6% 1/63 • Number of events 1
Injury, poisoning and procedural complications Forearm Fracture	1.7% 1/60 • Number of events 1	0.00% 0/63
Injury, poisoning and procedural complications Laceration	0.00% 0/60	1.6% 1/63 • Number of events 1
Metabolism and nutrition disorders Appetite Decreased N OS	1.7% 1/60 • Number of events 3	0.00% 0/63
Nervous system disorders Dizziness	0.00% 0/60	3.2% 2/63 • Number of events 2
Nervous system disorders Headache	8.3% 5/60 • Number of events 7	1.6% 1/63 • Number of events 1
Nervous system disorders Tremor	0.00% 0/60	1.6% 1/63 • Number of events 1
Psychiatric disorders Anxiety	0.00% 0/60	1.6% 1/63 • Number of events 1
Psychiatric disorders Panic Attack	0.00% 0/60	1.6% 1/63 • Number of events 1
Surgical and medical procedures Appendectomy	1.7% 1/60 • Number of events 1	0.00% 0/63
Surgical and medical procedures Internal Fixation of Fracture	1.7% 1/60 • Number of events 1	0.00% 0/63

Additional Information

Dr. Bob Harris

Westat

Phone: 301-251-1500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
Publication restrictions are in place

Restriction type: OTHER