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Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

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ClinicalTrials.gov Identifier: NCT00339040
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : January 16, 2012
Last Update Posted : January 13, 2015
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions HIV Infections
Sexually Transmitted Diseases
Interventions Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
Other: Placebo/QHPV
Enrollment 130
Recruitment Details Between October 11, 2006 and November 22, 2006 130 participants were enrolled at 34 clinical sites from US & Puerto Rico.
Pre-assignment Details Participants were stratified by CD4% criteria. Four participants were randomized but did not receive the study treatment. The study analyses were based on 126 participants who received the study treatment.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96. Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Period Title: Stage I
Started 96 30
Vaccination 1 at Week 0 96 30
Vaccination 2 at Week 8 95 30
Vaccination 3 at Week 24 94 30
Completed 94 29
Not Completed 2 1
Reason Not Completed
Not able to attend clinic             1             0
Protocol Violation             1             1
Period Title: Stage II
Started 94 29
Vaccination 4 at Week 96 84 29
Vaccination 5 at Week 104 0 28
Vaccination 6 at Week 120 0 27
Completed 84 27
Not Completed 10 2
Reason Not Completed
Lost to Follow-up             3             0
Withdrawal by Subject             1             2
Protocol Violation             3             0
Not able to attend clinic             1             0
Site closing             2             0
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV Total
Hide Arm/Group Description Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96. Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120. Total of all reporting groups
Overall Number of Baseline Participants 96 30 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 30 participants 126 participants
10.0  (1.4) 9.9  (1.3) 9.9  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 30 participants 126 participants
Female
53
  55.2%
18
  60.0%
71
  56.3%
Male
43
  44.8%
12
  40.0%
55
  43.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 30 participants 126 participants
White, non-Hispanic 4 2 6
Black, non-Hispanic 54 11 65
Hispanic 37 14 51
Others 1 3 4
Stratification groups   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 30 participants 126 participants
Stratum A 31 10 41
Stratum B 32 11 43
Stratum C 33 9 42
[1]
Measure Description:

STRATIFICATION: Participant were stratified by CD4% criteria into three strata:

  • Stratum A: CD4% Nadir < 15 and CD4% ≥ 15 at screening
  • Stratum B: CD4% Nadir ≥ 15 and < 25 and CD4% ≥ 15 at screening
  • Stratum C: CD4% Nadir ≥ 25 and CD4% ≥ 25 at screening
CD4 count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 96 participants 30 participants 126 participants
868  (367) 1013  (455) 903  (393)
CD4%  
Mean (Standard Deviation)
Unit of measure:  Percentage of total lymphocytes
Number Analyzed 96 participants 30 participants 126 participants
33.9  (7.9) 35.8  (8.6) 34.3  (8.1)
Log10(RNA)  
Mean (Standard Deviation)
Unit of measure:  Log10(copies/mL)
Number Analyzed 96 participants 30 participants 126 participants
2.7  (0.9) 2.6  (0.8) 2.7  (0.9)
RNA group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 96 participants 30 participants 126 participants
≤400 copies/mL 65 22 87
401 to ≤5000 copies/mL 16 5 21
>5000 copies/mL 15 3 18
1.Primary Outcome
Title Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)
Hide Description Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1="Mild", Grade 2="Moderate", Grade 3="Severe", Grade 4="Potentially Life-Threatening". All grade 3 and higher signs, symptoms, and laboratory toxicities were included.
Time Frame Within 14 days of first three doses of vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any participant who received at least one study vaccine/placebo were included in the safety analysis.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
7.3
(3.0 to 14.5)
6.7
(0.8 to 22.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A QHPV, Arm B Placebo/QHPV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment
Hide Description Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, "Treatment related", "Non-treatment related", "Baseline", "Possibly treatment related".
Time Frame Within 14 days of first three doses of vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any participant who received at least one study vaccine/placebo were included in the safety analysis
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
0
(0 to 0)
0
(0 to 0)
3.Primary Outcome
Title Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion
Hide Description Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.
Time Frame At week 28 after beginning the vaccination series
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
Serotype 6 (n=87, 27)
100.0
(95.9 to 100.0)
0.0
(0.0 to 12.8)
Serotype 11 (n=90, 27)
100.0
(95.9 to 100.0)
0.0
(0.0 to 12.8)
Serotype 16 (n=90, 27)
100.0
(95.9 to 100.0)
3.7
(0.1 to 19.0)
Serotype 18 (n=90, 27)
96.7
(90.6 to 99.3)
0.0
(0.0 to 12.8)
4.Primary Outcome
Title Serum Anti-HPV Antibody Titers (cLIA)
Hide Description Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)
Time Frame Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline as well as any participants with any missing values at any time points.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli-Merck units [mMU]/mL
Serotype 6 study entry (n=69, 23)
3.8
(3.5 to 4.1)
4.1
(3.4 to 4.9)
Serotype 6 week 28 (n=69, 23)
544.2
(395.4 to 749.1)
4.5
(3.7 to 5.4)
Serotype 6 week 72 (n=69, 23)
256.4
(196.5 to 334.7)
4.3
(3.6 to 5.1)
Serotype 6 week 96 (n=69, 23)
227.9
(167.3 to 310.3)
4.5
(3.6 to 5.8)
Serotype 6 week 97 (n=69, 23)
1604.8
(1162.0 to 2216.1)
17.1
(7.1 to 41.5)
Serotype 6 week 100 (n=69, 23)
2473.6
(1770.2 to 3456.4)
79.7
(43.7 to 145.3)
Serotype 6 week 124 (n=0, 23)
NA [1] 
(NA to NA)
678.8
(396.4 to 1162.2)
Serotype 11 study entry (n=72, 23)
4.1
(3.9 to 4.2)
4.0
(4.0 to 4.0)
Serotype 11 week 28 (n=72, 23)
1396.6
(1103.8 to 1767.1)
4.2
(3.8 to 4.7)
Serotype 11 week 72 (n=72, 23)
313.1
(234.4 to 418.3)
4.1
(3.9 to 4.5)
Serotype 11 week 96 (n=72, 23)
286.5
(207.1 to 396.4)
4.0
(4.0 to 4.0)
Serotype 11 week 97 (n=72, 23)
1931.7
(1389.1 to 2686.3)
11.8
(5.5 to 25.6)
Serotype 11 week 100 (n=72, 23)
3611.2
(2746.8 to 4747.6)
86.4
(48.7 to 153.6)
Serotype 11 week 124 (n=0, 23)
NA [1] 
(NA to NA)
1023.0
(704.2 to 1486.0)
Serotype 16 study entry (n=71, 23)
5.5
(5.5 to 5.5)
5.5
(5.5 to 5.5)
Serotype 16 week 28 (n=71, 23)
5172.5
(3889.8 to 6878.2)
5.7
(5.3 to 6.2)
Serotype 16 week 72 (n=71, 23)
1126.4
(788.6 to 1609.0)
5.5
(5.5 to 5.5)
Serotype 16 week 96 (n=71, 23)
1034.5
(708.8 to 1509.7)
5.5
(5.5 to 5.5)
Serotype 16 week 97 (n=71, 23)
6167.8
(4391.8 to 8661.8)
12.1
(5.4 to 27.1)
Serotype 16 week 100 (n=71, 23)
11205.6
(8184.7 to 15341.5)
142.6
(74.1 to 274.5)
Serotype 16 week 124 (n=0, 23)
NA [1] 
(NA to NA)
4113.8
(2404.2 to 7039.3)
Serotype 18 study entry (n=71, 23)
5.1
(4.9 to 5.3)
5.0
(5.0 to 5.0)
Serotype 18 week 28 (n=71, 23)
931.2
(616.7 to 1406.0)
5.0
(5.0 to 5.0)
Serotype 18 week 72 (n=71, 23)
148.2
(92.5 to 237.4)
5.0
(5.0 to 5.0)
Serotype 18 week 96 (n=71, 23)
142.0
(86.6 to 232.8)
5.0
(5.0 to 5.0)
Serotype 18 week 97 (n=71, 23)
925.7
(567.6 to 1510.0)
7.1
(4.6 to 11.0)
Serotype 18 week 100 (n=71, 23)
1530.7
(991.7 to 2362.4)
18.7
(10.6 to 32.8)
Serotype 18 week 124 (n=0, 23)
NA [1] 
(NA to NA)
734.3
(357.3 to 1508.8)
[1]
Week 124 is not a designated time point for Arm A.
5.Secondary Outcome
Title CD4 Count Over Time
Hide Description [Not Specified]
Time Frame Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any participant who received at least one study vaccine/placebo and with non-missing CD4 counts.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Mean (95% Confidence Interval)
Unit of Measure: cells/µL
CD4 count at study entry (n=96, 30)
868
(794 to 942)
1013
(843 to 1183)
CD4 count at week 8 (n=93, 30)
907
(830 to 985)
1018
(851 to 1185)
CD4 count at week 12 (n=93, 30)
906
(828 to 983)
1056
(830 to 1282)
CD4 count at week 24 (n=94, 30)
864
(792 to 936)
993
(826 to 1160)
CD4 count at week 28 (n=95, 30)
875
(800 to 950)
959
(803 to 1115)
CD4 count at week 72 (n=88, 30)
823
(746 to 900)
933
(768 to 1098)
CD4 count at week 96 (n=88, 30)
781
(712 to 849)
874
(718 to 1031)
CD4 count at week 100 (n=85, 29)
831
(754 to 907)
924
(766 to 1083)
CD4 count at week 104 (n=0, 27)
NA [1] 
(NA to NA)
929
(776 to 1082)
CD4 count at week 108 (n=82, 28)
839
(757 to 921)
980
(786 to 1174)
CD4 count at week 120 (n=0, 28)
NA [2] 
(NA to NA)
931
(745 to 1117)
CD4 count at week 124 (n=0, 27)
NA [3] 
(NA to NA)
920
(728 to 1112)
[1]
Week 104 is not a designated time point for Arm A.
[2]
Week 120 is not a designated time point for Arm A.
[3]
Week 124 is not a designated time point for Arm A.
6.Secondary Outcome
Title CD4 Percent Over Time
Hide Description [Not Specified]
Time Frame Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any participant who received at least one study vaccine/placebo and with non-missing CD4%.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Mean (95% Confidence Interval)
Unit of Measure: percentage of total lymphocytes
CD4 percent at study entry (n=96, 30)
34
(32 to 35)
36
(33 to 39)
CD4 percent at week 8 (n=93, 30)
34
(32 to 35)
36
(33 to 39)
CD4 percent at week 12 (n=93, 30)
35
(33 to 37)
37
(33 to 41)
CD4 percent at week 24 (n=94, 30)
34
(33 to 36)
35
(31 to 39)
CD4 percent at week 28 (n=95, 30)
34
(33 to 36)
34
(31 to 38)
CD4 percent at week 72 (n=88, 30)
33
(32 to 35)
34
(30 to 38)
CD4 percent at week 96 (n=88, 30)
33
(32 to 35)
34
(30 to 38)
CD4 percent at week 100 (n=85, 29)
35
(33 to 37)
35
(32 to 39)
CD4 percent at week 104 (n=0, 27)
NA [1] 
(NA to NA)
36
(32 to 40)
CD4 percent at week 108 (n=82, 28)
35
(33 to 37)
34
(30 to 38)
CD4 percent at week 120 (n=0, 28)
NA [2] 
(NA to NA)
37
(32 to 42)
CD4 percent at week 124 (n=0, 27)
NA [3] 
(NA to NA)
35
(31 to 39)
[1]
Week 104 is not a designated time point for Arm A.
[2]
Week 120 is not a designated time point for Arm A.
[3]
Week 124 is not a designated time point for Arm A.
7.Secondary Outcome
Title HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time
Hide Description [Not Specified]
Time Frame Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any participant who received at least one study vaccine/placebo and with non-missing HIV-1 viral load.
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description:
Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
Overall Number of Participants Analyzed 96 30
Log Mean (95% Confidence Interval)
Unit of Measure: Log10(copies/mL)
Log10(RNA) at study entry (n=96, 30)
2.7
(2.5 to 2.9)
2.6
(2.3 to 2.9)
Log10(RNA) at week 8 (n=92, 30)
2.8
(2.6 to 3.0)
2.8
(2.5 to 3.1)
Log10(RNA) at week 12 (n=93, 30)
2.7
(2.6 to 2.9)
2.8
(2.5 to 3.2)
Log10(RNA) at week 24 (n=94, 29)
2.8
(2.6 to 2.9)
2.7
(2.4 to 3.1)
Log10(RNA) at week 28 (n=95, 30)
2.7
(2.6 to 2.9)
2.8
(2.4 to 3.1)
Log10(RNA) at week 72 (n=87, 30)
2.7
(2.5 to 2.8)
2.7
(2.4 to 3.1)
Log10(RNA) at week 96 (n=88, 28)
2.6
(2.4 to 2.8)
2.4
(2.1 to 2.6)
Log10(RNA) at week 100 (n=84, 29)
2.6
(2.4 to 2.8)
2.4
(2.1 to 2.6)
Log10(RNA) at week 104 (n=0, 27)
NA [1] 
(NA to NA)
2.4
(2.0 to 2.7)
Log10(RNA) at week 108 (n=87, 28)
2.6
(2.4 to 2.7)
2.5
(2.1 to 2.8)
Log10(RNA) at week 120 (n=0, 28)
NA [2] 
(NA to NA)
2.3
(2.0 to 2.6)
Log10(RNA) at week 124 (n=0, 27)
NA [3] 
(NA to NA)
2.3
(1.9 to 2.6)
[1]
Week 104 is not a designated time point for Arm A.
[2]
Week 120 is not a designated time point for Arm A.
[3]
Week 124 is not a designated time point for Arm A.
Time Frame Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date).
Adverse Event Reporting Description Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and >=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
 
Arm/Group Title Arm A QHPV Arm B Placebo/QHPV
Hide Arm/Group Description Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96. Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
All-Cause Mortality
Arm A QHPV Arm B Placebo/QHPV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A QHPV Arm B Placebo/QHPV
Affected / at Risk (%) Affected / at Risk (%)
Total   5/96 (5.21%)   2/30 (6.67%) 
Blood and lymphatic system disorders     
Neutropenia  1  2/96 (2.08%)  0/30 (0.00%) 
General disorders     
Oedema peripheral  1  0/96 (0.00%)  1/30 (3.33%) 
Investigations     
Blood amylase increased  1  1/96 (1.04%)  0/30 (0.00%) 
Blood bilirubin increased  1  1/96 (1.04%)  0/30 (0.00%) 
Blood bilirubin unconjugated increased  1  0/96 (0.00%)  1/30 (3.33%) 
Neutrophil count decreased  1  1/96 (1.04%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A QHPV Arm B Placebo/QHPV
Affected / at Risk (%) Affected / at Risk (%)
Total   93/96 (96.88%)   30/30 (100.00%) 
Ear and labyrinth disorders     
Ear pain  1  5/96 (5.21%)  3/30 (10.00%) 
Eye disorders     
Conjunctivitis  1  5/96 (5.21%)  0/30 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  7/96 (7.29%)  0/30 (0.00%) 
Abdominal pain upper  1  6/96 (6.25%)  0/30 (0.00%) 
Diarrhoea  1  7/96 (7.29%)  2/30 (6.67%) 
Vomiting  1  9/96 (9.38%)  4/30 (13.33%) 
General disorders     
Chest pain  1  5/96 (5.21%)  0/30 (0.00%) 
Gait disturbance  1  0/96 (0.00%)  2/30 (6.67%) 
Injection site pain  1  13/96 (13.54%)  2/30 (6.67%) 
Pyrexia  1  14/96 (14.58%)  10/30 (33.33%) 
Infections and infestations     
Acute sinusitis  1  4/96 (4.17%)  5/30 (16.67%) 
Gastroenteritis  1  7/96 (7.29%)  0/30 (0.00%) 
Otitis media acute  1  4/96 (4.17%)  3/30 (10.00%) 
Pharyngitis  1  5/96 (5.21%)  3/30 (10.00%) 
Pharyngitis streptococcal  1  3/96 (3.13%)  3/30 (10.00%) 
Pneumonia  1  2/96 (2.08%)  2/30 (6.67%) 
Purulent discharge  1  0/96 (0.00%)  2/30 (6.67%) 
Investigations     
Alanine aminotransferase increased  1  20/96 (20.83%)  6/30 (20.00%) 
Aspartate aminotransferase increased  1  15/96 (15.63%)  10/30 (33.33%) 
Blood albumin abnormal  1  3/96 (3.13%)  2/30 (6.67%) 
Blood alkaline phosphatase increased  1  14/96 (14.58%)  1/30 (3.33%) 
Blood bicarbonate abnormal  1  21/96 (21.88%)  5/30 (16.67%) 
Blood bilirubin increased  1  11/96 (11.46%)  6/30 (20.00%) 
Blood cholesterol increased  1  17/96 (17.71%)  4/30 (13.33%) 
Blood creatinine increased  1  5/96 (5.21%)  3/30 (10.00%) 
Blood glucose decreased  1  37/96 (38.54%)  10/30 (33.33%) 
Blood glucose increased  1  12/96 (12.50%)  7/30 (23.33%) 
Blood phosphorus decreased  1  7/96 (7.29%)  1/30 (3.33%) 
Blood potassium decreased  1  12/96 (12.50%)  3/30 (10.00%) 
Blood sodium decreased  1  28/96 (29.17%)  11/30 (36.67%) 
Blood triglycerides increased  1  7/96 (7.29%)  0/30 (0.00%) 
Haemoglobin decreased  1  5/96 (5.21%)  1/30 (3.33%) 
Neutrophil count decreased  1  36/96 (37.50%)  10/30 (33.33%) 
Platelet count decreased  1  2/96 (2.08%)  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  3/96 (3.13%)  2/30 (6.67%) 
Nervous system disorders     
Headache  1  6/96 (6.25%)  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  3/96 (3.13%)  4/30 (13.33%) 
Bronchial hyperreactivity  1  1/96 (1.04%)  2/30 (6.67%) 
Cough  1  13/96 (13.54%)  9/30 (30.00%) 
Nasal congestion  1  10/96 (10.42%)  6/30 (20.00%) 
Oropharyngeal pain  1  11/96 (11.46%)  6/30 (20.00%) 
Rhonchi  1  0/96 (0.00%)  2/30 (6.67%) 
Wheezing  1  5/96 (5.21%)  5/30 (16.67%) 
Skin and subcutaneous tissue disorders     
Rash  1  5/96 (5.21%)  2/30 (6.67%) 
Skin lesion  1  0/96 (0.00%)  2/30 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and Merck & Co., Inc., 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.
Results Point of Contact
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
Phone: (617) 432-2829
Publications of Results:
P1047 ORAL PRESENTATION at the 25th International Papillomavirus Conference May 8-14 2009, Malmö, Sweden given by Anna Barbara Moscicki. Safety and immunogenicity of Gardasil® in HIV-infected children. Moscicki AB, Weinberg A, Song LY, Handelsman E, Patterson J, Saah A, Radley D, Read JS, Sattler C and Levin MJ for IMPAACT P1047 team.
Weinberg A, Song LY, Handelsman E, Moscicki AB, Patterson J, Saah A, Radley D, Esser M, Read J, and Levin MJ for IMPAACT P1047 Team. The P1047 data up to week 28 have been analyzed and presented to 15th CROI as abstract and poster #619a: Safety and Immunogenicity of a Quadrivalent Vaccine to Prevent Human Papilloma Virus (HPV) in HIV-Infected Children: IMPAACT P1047.
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00339040     History of Changes
Other Study ID Numbers: P1047
10163 ( Registry Identifier: DAIDS ES Registry Number )
PACTG P1047
First Submitted: June 19, 2006
First Posted: June 20, 2006
Results First Submitted: September 7, 2011
Results First Posted: January 16, 2012
Last Update Posted: January 13, 2015