Trial Outcomes & Findings for Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth (NCT NCT00459316)

Last Updated: 2021-11-03

Results Overview

Serum bactericidal antibody titers were measured at study entry and Week 28 for each of the four serogroups in the MCV-4 vaccine. Response was defined as a 4-fold or greater increase from entry at Week 28.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

384 participants

Primary outcome timeframe

Study entry and Week 28

Results posted on

2021-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: CD4%≥15, Age ≤11 to <25 Participants ≤11 to \<25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years. Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.	Group 2: CD4%<15, Age ≤11 to <25 Participants ≤11 to \<25 years of age with CD4% at screening \<15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24. Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.	Group 3: Age ≥2 to <11, CD4%≥25 Participants ≥2 to \<11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years. Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.
Steps 1 & 2 STARTED	280	39	59
Steps 1 & 2 COMPLETED	259	32	57
Steps 1 & 2 NOT COMPLETED	21	7	2
Step 3 STARTED	152	0	40
Step 3 COMPLETED	149	0	39
Step 3 NOT COMPLETED	3	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: CD4%≥15, Age ≤11 to <25 Participants ≤11 to \<25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years. Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.	Group 2: CD4%<15, Age ≤11 to <25 Participants ≤11 to \<25 years of age with CD4% at screening \<15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24. Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.	Group 3: Age ≥2 to <11, CD4%≥25 Participants ≥2 to \<11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years. Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.
Steps 1 & 2 Other eligibility failure	1	1	0
Steps 1 & 2 Death	1	1	0
Steps 1 & 2 Not able to get to clinic	7	4	0
Steps 1 & 2 Withdrawal by Subject	6	1	0
Steps 1 & 2 Not willing to adhere to regulations	1	0	0
Steps 1 & 2 Lost to Follow-up	5	0	2
Step 3 Withdrawal by Subject	3	0	1

Baseline Characteristics

Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (15<CD4%<25) n=127 Participants Participants ≥11 to \<25 years with 15\<CD4%\<25	Group 1 (CD4%≥25) n=153 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=39 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=59 Participants Participants ≥ 2 to \<11 years with CD4% ≥25	Total n=378 Participants Total of all reporting groups
Age, Continuous	18 years n=5 Participants	16 years n=7 Participants	20 years n=5 Participants	6 years n=4 Participants	16 years n=21 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	70 Participants n=7 Participants	16 Participants n=5 Participants	31 Participants n=4 Participants	161 Participants n=21 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	83 Participants n=7 Participants	23 Participants n=5 Participants	28 Participants n=4 Participants	217 Participants n=21 Participants
Race Asian	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Race Native Hawaiian or other Pacific islander	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Race Black or African American	72 participants n=5 Participants	69 participants n=7 Participants	22 participants n=5 Participants	34 participants n=4 Participants	197 participants n=21 Participants
Race White	47 participants n=5 Participants	75 participants n=7 Participants	14 participants n=5 Participants	21 participants n=4 Participants	157 participants n=21 Participants
Race American Indian	2 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Race More than One race	0 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Race Unknown	4 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	8 participants n=21 Participants
Ethnicity Hispanic or Latino	44 participants n=5 Participants	61 participants n=7 Participants	16 participants n=5 Participants	18 participants n=4 Participants	139 participants n=21 Participants
Ethnicity Not Hispanic or Latino	83 participants n=5 Participants	89 participants n=7 Participants	23 participants n=5 Participants	40 participants n=4 Participants	235 participants n=21 Participants
Ethnicity Unknown	0 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants
Screening CD4%	20.0 percent n=5 Participants	33.0 percent n=7 Participants	8.5 percent n=5 Participants	36.0 percent n=4 Participants	27.9 percent n=21 Participants
Entry plasma HIV RNA viral load, copies/mL <400 copies/mL	35 participants n=5 Participants	83 participants n=7 Participants	3 participants n=5 Participants	43 participants n=4 Participants	164 participants n=21 Participants
Entry plasma HIV RNA viral load, copies/mL ≥ 400 copies/mL	92 participants n=5 Participants	70 participants n=7 Participants	36 participants n=5 Participants	16 participants n=4 Participants	214 participants n=21 Participants
CDC Classification at Study Entry C	28 participants n=5 Participants	37 participants n=7 Participants	11 participants n=5 Participants	8 participants n=4 Participants	84 participants n=21 Participants
CDC Classification at Study Entry Not C	99 participants n=5 Participants	116 participants n=7 Participants	28 participants n=5 Participants	51 participants n=4 Participants	294 participants n=21 Participants
Antiretroviral (ARV) Treatment at Entry HAART with PI	70 participants n=5 Participants	81 participants n=7 Participants	22 participants n=5 Participants	38 participants n=4 Participants	211 participants n=21 Participants
Antiretroviral (ARV) Treatment at Entry HAART with NNRTI (no PI)	14 participants n=5 Participants	34 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants	65 participants n=21 Participants
Antiretroviral (ARV) Treatment at Entry Other ARV	6 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	16 participants n=21 Participants
Antiretroviral (ARV) Treatment at Entry No ARV	37 participants n=5 Participants	30 participants n=7 Participants	13 participants n=5 Participants	6 participants n=4 Participants	86 participants n=21 Participants

PRIMARY outcome

Timeframe: Study entry and Week 28

Population: This outcome only includes participants who received 2 doses and had antibody data from both entry and Week 28.The number of participants analyzed for Group 1 (15\<CD4%\<25), Group 1 (CD4%≥25), Group 2, Group 3 are respectively: serogroup A: 49, 63, 20, 49 serogroup C: 47, 65, 18, 49 serogroup W-135: 47, 66, 19, 49 serogroup Y: 49, 66, 19, 49

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=49 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=66 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=20 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=49 Participants Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4. Week 28 reponders, serogroup W-135	36 participants Interval 0.5 to 0.78	61 participants Interval 0.7 to 0.9	0 participants Interval 0.0 to 0.18	49 participants Interval 0.93 to 1.0
Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4. Week 28 reponders, serogroup A	27 participants Interval 0.87 to 0.99	60 participants Interval 0.4 to 0.69	8 participants Interval 0.19 to 0.64	43 participants Interval 0.75 to 0.95
Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4. Week 28 reponders, serogroup C	28 participants Interval 0.44 to 0.74	49 participants Interval 0.63 to 0.85	1 participants Interval 0.001 to 0.27	39 participants Interval 0.66 to 0.9
Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4. Week 28 reponders, serogroup Y	32 participants Interval 0.62 to 0.88	54 participants Interval 0.83 to 0.97	1 participants Interval 0.001 to 0.25	41 participants Interval 0.7 to 0.93

PRIMARY outcome

Timeframe: At Study entry, Week 4

Population: This outcome only includes participants who had antibody data from both entry and Week 4.The number of participants analyzed for Group 1 (15\<CD4%\<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are: serogroup A are 93, 129, 20, 49 serogroup C are 90, 130, 18, 49 serogroup W-135 are 91, 131, 19, 49 serogroup Y are 93, 131, 20, 49

Serum bactericidal antibody titers were measured at study entry and Week 4 for each of the four serogroups in the MCV-4 vaccine. Response (seroconversion) was defined as a 4-fold or greater increase from entry at Week 4.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=93 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=131 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=20 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=49 Participants Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline) Week 4 Seroconverters, serogroup C	44 participants	89 participants	3 participants	21 participants
Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline) Week 4 Seroconverters, serogroup A	61 participants	107 participants	5 participants	45 participants
Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline) Week 4 Seroconverters, serogroup W-135	66 participants	118 participants	6 participants	48 participants
Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline) Week 4 Seroconverters, serogroup Y	49 participants	100 participants	8 participants	37 participants

PRIMARY outcome

Timeframe: Week 72

Population: Participants with antibody data at Week 72. The number of Participants analyzed for Group 1 (15\<CD4%\<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are: serogroup A are 82, 108, 18, 44 serogroup C are 78, 110, 16, 44 serogroup W-135 are 80, 110, 17, 44 serogroup Y are 82, 110, 18, 44

Protective levels of antibody are titers ≥1:128.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=82 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=110 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=18 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=44 Participants Participants ≥ 2 to \<11 years with CD4% ≥25
Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72 Week 72 Responders, serogroup Y	49 participants	80 participants	5 participants	40 participants
Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72 Week 72 Responders, serogroup A	39 participants	82 participants	4 participants	35 participants
Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72 Week 72 Responders, serogroup C	17 participants	36 participants	1 participants	20 participants
Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72 Week 72 Responders, serogroup W-135	36 participants	83 participants	6 participants	42 participants

PRIMARY outcome

Timeframe: From administration of Dose 1 at week 0 to 42 days post-vaccination

Population: All participants who received Dose 1.

Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=127 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=153 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=39 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=59 Participants Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.	3 participants	1 participants	3 participants	0 participants

PRIMARY outcome

Timeframe: From administration of Dose 2 at week 24 to 6 weeks post-vaccination

Population: All participants who entered Step 2

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=111 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=144 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=31 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=58 Participants Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.	0 participants	0 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: At 3.5 years (Step 3 entry)

Population: All participants who had antibody data for Step 3 Week 0

Immunogenicity was assessed for each serogroup by the number of participants with protective antibody levels (titers greater than or equal to 1:128)

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=77 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=39 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Immunogenicity at Step 3 Entry Immunogenicity, Serogroup A	47 participants Interval 0.52 to 0.75	48 participants Interval 0.51 to 0.73	34 participants Interval 0.73 to 0.96	—
Number of Participants With Immunogenicity at Step 3 Entry Immunogenicity, Serogroup C	19 participants Interval 0.16 to 0.38	20 participants Interval 0.17 to 0.37	9 participants Interval 0.11 to 0.39	—
Number of Participants With Immunogenicity at Step 3 Entry Immunogenicity, Serogroup W-135	30 participants Interval 0.3 to 0.53	35 participants Interval 0.34 to 0.57	23 participants Interval 0.42 to 0.74	—
Number of Participants With Immunogenicity at Step 3 Entry Immunogenicity, Serogroup Y	39 participants Interval 0.41 to 0.65	33 participants Interval 0.32 to 0.55	24 participants Interval 0.45 to 0.77	—

PRIMARY outcome

Timeframe: Step 3 entry and Week 1 post-booster vaccine

Population: Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.

Defined for each serogroup as a four-fold rise in antibody titers between booster dose (week 0) and week 1.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=65 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=36 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With 4-fold Memory Response in Step 3 4-fold memory responders, serogroup A	54 participants Interval 0.62 to 0.84	49 participants Interval 0.61 to 0.83	33 participants Interval 0.78 to 1.0	—
Number of Participants With 4-fold Memory Response in Step 3 4-fold memory responders, serogroup C	56 participants Interval 0.65 to 0.86	50 participants Interval 0.63 to 0.84	34 participants Interval 0.81 to 0.99	—
Number of Participants With 4-fold Memory Response in Step 3 4-fold memory responders, serogroup W-135	63 participants Interval 0.76 to 0.93	55 participants Interval 0.73 to 0.92	33 participants Interval 0.78 to 0.98	—
Number of Participants With 4-fold Memory Response in Step 3 4-fold memory responders, serogroup Y	54 participants Interval 0.62 to 0.84	51 participants Interval 0.67 to 0.88	33 participants Interval 0.78 to 0.98	—

PRIMARY outcome

Timeframe: Step 3 entry and Week 1 post-booster vaccine

Population: Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.

Seropositive memory response was defined for each serogroup by having protective antibody levels (titer \>= 1:128) on Day 0 or change from seronegative to seropositive between booster dose (Day 0) and Day 7.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=65 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=36 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Seropositive Memory Response (in Step 3) Seropositive memory responder, serogroup A	65 participants Interval 0.8 to 0.95	61 participants Interval 0.83 to 0.98	35 participants Interval 0.85 to 1.0	—
Number of Participants With Seropositive Memory Response (in Step 3) Seropositive memory responder, serogroup C	62 participants Interval 0.75 to 0.92	55 participants Interval 0.71 to 0.9	34 participants Interval 0.81 to 0.99	—
Number of Participants With Seropositive Memory Response (in Step 3) Seropositive memory responder, serogroup W-135	65 participants Interval 0.8 to 0.95	60 participants Interval 0.8 to 0.96	34 participants Interval 0.81 to 0.99	—
Number of Participants With Seropositive Memory Response (in Step 3) Seropositive memory responder, serogroup Y	67 participants Interval 0.83 to 0.97	57 participants Interval 0.74 to 0.93	33 participants Interval 0.78 to 0.98	—

PRIMARY outcome

Timeframe: Step 3 entry and Week 4 post-booster vaccine

Population: Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.

Primary response was defined for each serogroup as a four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; OR a change from seronegative on day 0 to seropositive on day 28, but not between day 0 and day 7. Note: a primary response can only occur in the absence of any memory response.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=65 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=36 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Primary Response (in Step 3) Primary responder, serogroup A	2 participants Interval 0.0 to 0.1	2 participants Interval 0.0 to 0.1	0 participants Interval 0.0 to 0.1	—
Number of Participants With Primary Response (in Step 3) Primary responder, serogroup C	1 participants Interval 0.0 to 0.07	1 participants Interval 0.0 to 0.08	1 participants Interval 0.0 to 0.15	—
Number of Participants With Primary Response (in Step 3) Primary responder, serogroup W-135	1 participants Interval 0.0 to 0.07	0 participants Interval 0.0 to 0.05	2 participants Interval 0.01 to 0.19	—
Number of Participants With Primary Response (in Step 3) Primary responder, serogroup Y	1 participants Interval 0.0 to 0.07	2 participants Interval 0.0 to 0.11	2 participants Interval 0.01 to 0.19	—

PRIMARY outcome

Timeframe: At Step 3 Weeks 4 and 24 post-booster vaccine

Population: Participants with data for Step 3 weeks 4 and 24. The numbers for Group 1 (1-dose), Group 1 (2-dose), and Group 3 respectively are: Week 4: 73, 71, 37 Week 24: 73, 70, 33

Immunogenicity was assessed by the number of participants with protective levels of antibody (titers greater than or equal to 1:128)

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=79 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=38 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 24 immunogenicity, serogroup Y	58 participants Interval 0.68 to 0.88	52 participants Interval 0.61 to 0.84	31 participants Interval 0.79 to 0.99	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 4 immunogenicity, serogroup A	66 participants Interval 0.81 to 0.96	67 participants Interval 0.86 to 0.98	37 participants Interval 0.86 to 1.0	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 4 immunogenicity, serogroup C	61 participants Interval 0.73 to 0.91	60 participants Interval 0.77 to 0.94	35 participants Interval 0.78 to 0.98	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 4 immunogenicity, serogroup W-135	67 participants Interval 0.83 to 0.97	64 participants Interval 0.82 to 0.97	37 participants Interval 0.86 to 1.0	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 4 immunogenicity, serogroup Y	67 participants Interval 0.83 to 0.97	62 participants Interval 0.78 to 0.95	35 participants Interval 0.78 to 0.98	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 24 immunogenicity, serogroup A	58 participants Interval 0.7 to 0.89	59 participants Interval 0.73 to 0.92	30 participants Interval 0.75 to 0.98	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 24 immunogenicity, serogroup C	41 participants Interval 0.44 to 0.68	46 participants Interval 0.52 to 0.76	24 participants Interval 0.53 to 0.86	—
Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24 Week 24 immunogenicity, serogroup W-135	57 participants Interval 0.67 to 0.87	53 participants Interval 0.63 to 0.85	32 participants Interval 0.84 to 1.0	—

SECONDARY outcome

Timeframe: At Weeks 4, 28, and 72

Population: Group 2 participants with response data for weeks 4, 28 and 72

Immunogenic response as assessed by number of participants with protective antibody titers (\>= 1:128) to serogroup C in Group 2 (entry CD4%\<15)

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=18 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=18 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=16 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Immunogenic Response to Serogroup C in Group 2	4 participants	4 participants	1 participants	—

SECONDARY outcome

Timeframe: At 3.5 years

Population: Group 1 and 3 participants at entry to Step 3

Number of participants with protective antibody titers (rSBA\>=1:128) for serogroup C by treatment arm (1 vs. 2 doses) of Group 1 (entry CD4% \>= 15) at Step 3 entry

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=65 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=20 Participants Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=16 Participants Participants ≥ 2 to \<11 years with CD4% ≥25
Number of Participants With Protective Antibody Titers for Serogroup C at Step 3 Entry	19 participants	17 participants	3 participants	6 participants

SECONDARY outcome

Timeframe: At Week 1 post-booster vaccination

Population: Participants in Group 1 who entered Step 3

Evidence of immunologic memory according to each of the following definitions: 1. Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or 2. Seroprotection on day 0 or change from titer \<1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=65 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Immunologic Memory for Serogroup C by Treatment Arm (1 vs. 2 Doses)	65 participants	61 participants	—	—

SECONDARY outcome

Timeframe: At Week 4 post-booster vaccination

Population: Group 1 participants who entered Step 3

Immunologic Memory defined as: 1. Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or 2. Seroprotection on day 0 or change from titer \<1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7. Primary Response defined as: 1. A four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; or 2. A change from titer \<1:128 on day 0 to titer ≥1:128on day 28, but not between day 0 and day 7.

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=73 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=65 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Immunologic Memory or Primary Response for Serogroup C by Treatment Arm	64 participants	57 participants	—	—

SECONDARY outcome

Timeframe: From administration of vaccination at Step 3 entry through 6 weeks post-vaccination

Population: All participants who were vaccinated at Step 3 entry

Outcome measures

Outcome measures
Measure	Group 1 (15<CD4%<25) n=152 Participants Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=40 Participants Participants ≥11 to \<25 years with CD4%≥25	Group 2 Participants ≥11 to \<25 years with CD4%\<15	Group 3 Participants ≥ 2 to \<11 years with CD4% ≥25
Safety, as Assessed by Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Step 3 Dose of the Vaccine.	2 participants	0 participants	—	—

Adverse Events

Group 1 (15<CD4%≤25)

Serious events: 4 serious events

Other events: 94 other events

Deaths: 0 deaths

Group 1 (CD4%≥25)

Serious events: 5 serious events

Other events: 113 other events

Deaths: 0 deaths

Group 2

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Group 3

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 (15<CD4%≤25) n=127 participants at risk Participants ≥11 to \<25 years with 15\<CD4%≤25	Group 1 (CD4%≥25) n=153 participants at risk Participants ≥11 to \<25 years with CD4%≥25	Group 2 n=39 participants at risk Participants ≥11 to \<25 years with CD4%\<15	Group 3 n=59 participants at risk Participants ≥ 2 to \<11 years with CD4% ≥25
Hepatobiliary disorders Hepatitis	0.79% 1/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Infections and infestations Candida sepsis	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	2.6% 1/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Infections and infestations Pelvic inflammatory disease	0.79% 1/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Infections and infestations Pneumonia	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	1.7% 1/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Injury, poisoning and procedural complications Overdose	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.65% 1/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.65% 1/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	1.7% 1/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Nervous system disorders Headache	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.65% 1/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Nervous system disorders Migraine	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	2.6% 1/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Nervous system disorders Neuropathy peripheral	0.79% 1/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.79% 1/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	1.3% 2/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	2.6% 1/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Renal and urinary disorders Nephrolithiasis	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	2.6% 1/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.
Skin and subcutaneous tissue disorders Rash	0.00% 0/127 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/153 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	2.6% 1/39 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.	0.00% 0/59 • From study entry through Step 3, week 24 (4 years ) All vaccine-related Grade ≥ 3 toxicities, and any new Grade 2 or higher neuromuscular weakness occurring within 42 days of vaccination were reported. Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009.

Other adverse events

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Publication restrictions are in place

Restriction type: OTHER