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Trial record 2 of 2 for:    anal cancer | Rhode Island, United States

Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01461096
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : February 7, 2017
Last Update Posted : March 21, 2017
Sponsor:
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Biological: Quadrivalent HPV Vaccine
Biological: Placebo Vaccine for Male Participants Only
Biological: Placebo Vaccine for Female Participants Only
Enrollment 575
Recruitment Details In less than 18 months, the full study cohort of 575 participants (472 males and 103 females) were enrolled and randomized in A5298. The first participant was randomized on March 8, 2012 and the last was randomized on August 23, 2013.
Pre-assignment Details  
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine
Hide Arm/Group Description

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Period Title: Overall Study
Started 288 287
Did Not Start Treatment 0 1 [1]
Completed [2] 226 226
Not Completed 62 61
Reason Not Completed
Death             3             6
Severe debilitation, unable to continue             1             1
Subj not able to get to clinic             15             13
Site is closing             27             30
Withdrawal by Subject             5             3
Subj not willing to adhere to reqs             3             4
Lost to Follow-up             8             4
[1]
Randomized but never started treatment and was discontinued from the study
[2]
Unexpected closure of study. Completed study requirements up to the time of unexpected closure.
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine Total
Hide Arm/Group Description

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Total of all reporting groups
Overall Number of Baseline Participants 288 287 575
Hide Baseline Analysis Population Description
All participants randomized who had results for the respective baseline measure available. The numbers of participants for each measure are shown below.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 288 participants 287 participants 575 participants
47
(40 to 52)
48
(42 to 53)
47
(41 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 287 participants 575 participants
Female
52
  18.1%
51
  17.8%
103
  17.9%
Male
236
  81.9%
236
  82.2%
472
  82.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 287 participants 575 participants
White Non-Hispanic
125
  43.4%
136
  47.4%
261
  45.4%
Black Non-Hispanic
91
  31.6%
89
  31.0%
180
  31.3%
Hispanic (Regardless of Race)
63
  21.9%
54
  18.8%
117
  20.3%
Asian, Pacific Islander
5
   1.7%
7
   2.4%
12
   2.1%
American Indian, Alaskan Native
2
   0.7%
0
   0.0%
2
   0.3%
More than one race
2
   0.7%
1
   0.3%
3
   0.5%
Presence of HGAIN at entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 287 participants 575 participants
HGAIN
95
  33.0%
92
  32.1%
187
  32.5%
No HGAIN
193
  67.0%
195
  67.9%
388
  67.5%
IV drug history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 287 participants 575 participants
Never
270
  93.8%
259
  90.2%
529
  92.0%
Previously
18
   6.3%
28
   9.8%
46
   8.0%
HIV RNA results (copies/mL)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 287 participants 575 participants
<50
226
  78.5%
244
  85.0%
470
  81.7%
50-<200
23
   8.0%
15
   5.2%
38
   6.6%
200-<500
13
   4.5%
4
   1.4%
17
   3.0%
500-<1000
3
   1.0%
4
   1.4%
7
   1.2%
1000-<10000
10
   3.5%
6
   2.1%
16
   2.8%
>=10000
7
   2.4%
9
   3.1%
16
   2.8%
Missing
6
   2.1%
5
   1.7%
11
   1.9%
Lowest documented CD4 count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 260 participants 255 participants 515 participants
254
(105 to 373)
259
(119 to 419)
255
(110 to 403)
[1]
Measure Analysis Population Description: Row population differs from the overall due to Missing
Absolute CD4 count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 285 participants 284 participants 569 participants
598
(438 to 761)
614
(435 to 803)
602
(436 to 767)
[1]
Measure Analysis Population Description: Row population differs from the overall due to Missing
Percent CD4   [1] 
Median (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 285 participants 284 participants 569 participants
32
(25.00 to 38.80)
31
(23.90 to 37.90)
31.70
(25 to 38)
[1]
Measure Analysis Population Description: Row population differs from the overall due to Missing
1.Primary Outcome
Title Time to the First New Persistent Infection of HPV 6, 11, 16, or 18
Hide Description

The outcome for this evaluation was time to the first new persistent infection of any of HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive anal HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary outcome if they were PCR negative for at least one of the four vaccine HPV types at baseline.

NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure.

Time Frame From baseline to participant's last study visit, for up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis for persistent anal HPV employed a modified intent-to-treat (mITT) approach wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine
Hide Arm/Group Description:

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Overall Number of Participants Analyzed 286 283
Measure Type: Number
Number (95.1% Confidence Interval)
Unit of Measure: Years
5th percentile
1.90
(0.94 to 2.46)
1.04
(0.52 to 2.05)
10th percentile
2.92 [1] 
(2.46 to NA)
2.05
(1.94 to 2.95)
[1]
Not estimable as the upper limit for survival function at all years was above 90%.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quadrivalent HPV Vaccine, Placebo Vaccine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.350
Comments P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.
Method generalized log-rank test (Sun 1996)
Comments The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95.1%
0.47 to 1.31
Estimation Comments qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.
2.Secondary Outcome
Title Number of Participants With Biopsy-proven High-grade Anal Intraepithelial Neoplasia (HGAIN) Occurrences and Reoccurrences After Week 52
Hide Description HGAIN was defined as AIN2 (moderate dysplasia, with no mention of AIN grade III), AIN3 (severe dysplasia, carcinoma in-situ, or AIN grade II/III), high grade AIN not specified, or adenocarcinoma in situ found in the intra-anal or perianal region.
Time Frame From Week 52 to participant's last study visit, for up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population including all participants who received at least one dose of vaccine.
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine
Hide Arm/Group Description:

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Overall Number of Participants Analyzed 288 286
Measure Type: Count of Participants
Unit of Measure: Participants
46
  16.0%
45
  15.7%
3.Secondary Outcome
Title Number of Participants With Anal Cytological Abnormality Occurrences
Hide Description Anal cytologic abnormalities include: atypical squamous cells undetermined significance (ASCUS), atypical squamous cells favor high-grade SIL/squamous cell carcinoma (ASC-H), low-grade squamous intraepithelial lesion/mild dysplasia/HPV (LSIL), or high-grade SIL/moderate dysplasia to severe dysplasia/carcinoma in situ/features of invasion (HSIL).
Time Frame At baseline, Week 52, Week 104 and Week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population including all participants who received at least one dose of vaccine.
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine
Hide Arm/Group Description:

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Overall Number of Participants Analyzed 288 286
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal cytology at baseline Number Analyzed 285 participants 284 participants
182
  63.9%
188
  66.2%
Abnormal cytology at Week 52 visit Number Analyzed 231 participants 229 participants
123
  53.2%
121
  52.8%
Abnormal cytology at Week 104 visit Number Analyzed 199 participants 198 participants
98
  49.2%
108
  54.5%
Abnormal cytology at Week 156 visit Number Analyzed 130 participants 132 participants
58
  44.6%
72
  54.5%
4.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine, as Determined by the Local Investigator
Hide Description To grade diagnoses, signs and symptoms, and laboratory results, sites must refer to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, august 2009).
Time Frame From baseline to participant's last study visit, for up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population including all participants who received at least one dose of vaccine.
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine
Hide Arm/Group Description:

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Overall Number of Participants Analyzed 288 286
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.3%
0
   0.0%
5.Secondary Outcome
Title Time to First New Persistent Oral HPV Infection of Vaccine Types Detected From Oral Rinse
Hide Description

The outcome for this evaluation was time to the first new persistent infection of any of oral HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive oral HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary endpoint if they were PCR negative for at least one of the four vaccine HPV types at baseline.

NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure.

Time Frame From baseline to participant's last study visit, for up to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.
Arm/Group Title Quadrivalent HPV Vaccine Placebo Vaccine
Hide Arm/Group Description:

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Overall Number of Participants Analyzed 288 286
Measure Type: Number
Number (95.1% Confidence Interval)
Unit of Measure: Years
5th percentile
NA [1] 
(2.99 to NA)
NA [2] 
(1.90 to NA)
10th percentile
NA [3] 
(NA to NA)
NA [3] 
(NA to NA)
[1]
Not estimable as the estimate for survival function at all years was above 95%. (Note: A total of 7 events were observed, and the 3-year persistent infection free rate was about 0.97.)
[2]
Not estimable as the estimate for survival function at all years was above 95%. (Note: A total of 10 events were observed, and the 3-year persistent infection free rate was about 0.96.)
[3]
Not estimable as the estimate for survival function at all years was above 90%.
Time Frame From baseline to participant's last study visit, for up to 4 years
Adverse Event Reporting Description At entry, the protocol required reporting of signs/symptoms >=Grade 3 that occurred within 14 days before entry. After entry, the protocol required reporting of signs/symptoms >=Grade 3, laboratory results >=Grade 3 and events that led to a change in treatment, regardless of grade. HGB, PLT, ANC, AST, ALT, INR, total and direct bilirubin, creatinine were reported regardless of grade. The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.
 
Arm/Group Title qHPV Placebo
Hide Arm/Group Description

Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.

Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.

Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.

All-Cause Mortality
qHPV Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/288 (1.04%)   6/287 (2.09%) 
Show Serious Adverse Events Hide Serious Adverse Events
qHPV Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   33/288 (11.46%)   46/287 (16.03%) 
Cardiac disorders     
Acute myocardial infarction  1  0/288 (0.00%)  2/287 (0.70%) 
Coronary artery disease  1  0/288 (0.00%)  1/287 (0.35%) 
Myocardial infarction  1  0/288 (0.00%)  1/287 (0.35%) 
Pericardial effusion  1  1/288 (0.35%)  0/287 (0.00%) 
Gastrointestinal disorders     
Abdominal mass  1  1/288 (0.35%)  0/287 (0.00%) 
Abdominal pain  1  1/288 (0.35%)  1/287 (0.35%) 
Anal fistula  1  1/288 (0.35%)  0/287 (0.00%) 
Colitis  1  1/288 (0.35%)  0/287 (0.00%) 
Gastrointestinal haemorrhage  1  0/288 (0.00%)  1/287 (0.35%) 
Large intestine perforation  1  0/288 (0.00%)  1/287 (0.35%) 
Pancreatitis  1  0/288 (0.00%)  1/287 (0.35%) 
Pancreatitis acute  1  0/288 (0.00%)  2/287 (0.70%) 
Pancreatitis chronic  1  0/288 (0.00%)  1/287 (0.35%) 
Small intestinal obstruction  1  0/288 (0.00%)  3/287 (1.05%) 
General disorders     
Chest pain  1  2/288 (0.69%)  5/287 (1.74%) 
Death  1  1/288 (0.35%)  0/287 (0.00%) 
Pyrexia  1  0/288 (0.00%)  1/287 (0.35%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/288 (0.00%)  1/287 (0.35%) 
Infections and infestations     
Appendicitis  1  1/288 (0.35%)  0/287 (0.00%) 
Bronchitis  1  0/288 (0.00%)  2/287 (0.70%) 
Cellulitis  1  1/288 (0.35%)  0/287 (0.00%) 
Chlamydial infection  1  1/288 (0.35%)  0/287 (0.00%) 
Diverticulitis  1  0/288 (0.00%)  2/287 (0.70%) 
Gastroenteritis  1  0/288 (0.00%)  2/287 (0.70%) 
Gastroenteritis viral  1  1/288 (0.35%)  1/287 (0.35%) 
Influenza  1  2/288 (0.69%)  2/287 (0.70%) 
Meningitis viral  1  1/288 (0.35%)  0/287 (0.00%) 
Orchitis  1  0/288 (0.00%)  1/287 (0.35%) 
Perirectal abscess  1  0/288 (0.00%)  1/287 (0.35%) 
Peritonsillar abscess  1  1/288 (0.35%)  0/287 (0.00%) 
Pneumonia  1  2/288 (0.69%)  3/287 (1.05%) 
Pneumonia pneumococcal  1  1/288 (0.35%)  0/287 (0.00%) 
Pneumonia streptococcal  1  0/288 (0.00%)  1/287 (0.35%) 
Primary syphilis  1  0/288 (0.00%)  1/287 (0.35%) 
Pseudomembranous colitis  1  1/288 (0.35%)  0/287 (0.00%) 
Pyelonephritis  1  0/288 (0.00%)  1/287 (0.35%) 
Scrotal abscess  1  0/288 (0.00%)  1/287 (0.35%) 
Sepsis  1  1/288 (0.35%)  3/287 (1.05%) 
Viral infection  1  0/288 (0.00%)  1/287 (0.35%) 
Injury, poisoning and procedural complications     
Fall  1  0/288 (0.00%)  1/287 (0.35%) 
Foot fracture  1  0/288 (0.00%)  1/287 (0.35%) 
Lower limb fracture  1  1/288 (0.35%)  0/287 (0.00%) 
Multiple injuries  1  1/288 (0.35%)  0/287 (0.00%) 
Overdose  1  0/288 (0.00%)  1/287 (0.35%) 
Radius fracture  1  0/288 (0.00%)  1/287 (0.35%) 
Road traffic accident  1  0/288 (0.00%)  1/287 (0.35%) 
Stab wound  1  1/288 (0.35%)  0/287 (0.00%) 
Investigations     
Weight decreased  1  0/288 (0.00%)  1/287 (0.35%) 
Metabolism and nutrition disorders     
Dehydration  1  0/288 (0.00%)  1/287 (0.35%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/288 (0.00%)  1/287 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer  1  1/288 (0.35%)  1/287 (0.35%) 
Anal squamous cell carcinoma  1  0/288 (0.00%)  1/287 (0.35%) 
B-cell lymphoma  1  0/288 (0.00%)  1/287 (0.35%) 
Basal cell carcinoma  1  1/288 (0.35%)  1/287 (0.35%) 
Follicle centre lymphoma diffuse small cell lymphoma  1  0/288 (0.00%)  1/287 (0.35%) 
Hodgkin's disease  1  1/288 (0.35%)  0/287 (0.00%) 
Oesophageal adenocarcinoma  1  0/288 (0.00%)  1/287 (0.35%) 
Pancreatic carcinoma metastatic  1  0/288 (0.00%)  1/287 (0.35%) 
Prostate cancer  1  1/288 (0.35%)  1/287 (0.35%) 
Renal cell carcinoma  1  0/288 (0.00%)  1/287 (0.35%) 
Squamous cell carcinoma of head and neck  1  0/288 (0.00%)  1/287 (0.35%) 
Transitional cell carcinoma  1  1/288 (0.35%)  0/287 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/288 (0.35%)  0/287 (0.00%) 
Haemorrhagic stroke  1  0/288 (0.00%)  1/287 (0.35%) 
Seizure  1  1/288 (0.35%)  0/287 (0.00%) 
Syncope  1  0/288 (0.00%)  2/287 (0.70%) 
Psychiatric disorders     
Acute psychosis  1  1/288 (0.35%)  0/287 (0.00%) 
Alcohol withdrawal syndrome  1  1/288 (0.35%)  1/287 (0.35%) 
Completed suicide  1  0/288 (0.00%)  1/287 (0.35%) 
Depression  1  1/288 (0.35%)  0/287 (0.00%) 
Mental status changes  1  0/288 (0.00%)  1/287 (0.35%) 
Psychotic disorder  1  0/288 (0.00%)  1/287 (0.35%) 
Substance abuse  1  0/288 (0.00%)  1/287 (0.35%) 
Suicide attempt  1  1/288 (0.35%)  1/287 (0.35%) 
Reproductive system and breast disorders     
Genital ulceration  1  0/288 (0.00%)  1/287 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/288 (0.35%)  0/287 (0.00%) 
Alveolitis allergic  1  1/288 (0.35%)  0/287 (0.00%) 
Asthma  1  1/288 (0.35%)  0/287 (0.00%) 
Chronic obstructive pulmonary disease  1  0/288 (0.00%)  4/287 (1.39%) 
Dyspnoea  1  0/288 (0.00%)  1/287 (0.35%) 
Pleural effusion  1  1/288 (0.35%)  1/287 (0.35%) 
Pulmonary hypertension  1  0/288 (0.00%)  1/287 (0.35%) 
Surgical and medical procedures     
Intervertebral disc operation  1  1/288 (0.35%)  0/287 (0.00%) 
Vascular disorders     
Hypotension  1  0/288 (0.00%)  1/287 (0.35%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
qHPV Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   87/288 (30.21%)   95/287 (33.10%) 
Gastrointestinal disorders     
Abdominal pain  1  13/288 (4.51%)  16/287 (5.57%) 
Anogenital dysplasia  1  11/288 (3.82%)  20/287 (6.97%) 
Diarrhoea  1  16/288 (5.56%)  26/287 (9.06%) 
Nausea  1  16/288 (5.56%)  20/287 (6.97%) 
Vomiting  1  7/288 (2.43%)  20/287 (6.97%) 
General disorders     
Chills  1  21/288 (7.29%)  17/287 (5.92%) 
Fatigue  1  18/288 (6.25%)  19/287 (6.62%) 
Pyrexia  1  31/288 (10.76%)  30/287 (10.45%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  14/288 (4.86%)  18/287 (6.27%) 
Pain in extremity  1  22/288 (7.64%)  19/287 (6.62%) 
Nervous system disorders     
Headache  1  16/288 (5.56%)  17/287 (5.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  33/288 (11.46%)  22/287 (7.67%) 
Dyspnoea  1  19/288 (6.60%)  20/287 (6.97%) 
Nasal congestion  1  18/288 (6.25%)  14/287 (4.88%) 
Oropharyngeal pain  1  19/288 (6.60%)  10/287 (3.48%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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 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
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01461096     History of Changes
Other Study ID Numbers: A5298
11798 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: October 26, 2011
First Posted: October 27, 2011
Results First Submitted: December 14, 2016
Results First Posted: February 7, 2017
Last Update Posted: March 21, 2017