Trial Outcomes & Findings for Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts (NCT NCT02750202)
NCT ID: NCT02750202
Last Updated: 2026-01-23
Results Overview
The number of participants in whom the size of the genital wart lesion(s) measured smaller at Week8, Week24 and Week60 as compared to their baseline measurement (all measured in mm).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Baseline, week 8, 24, 60
Results posted on
2026-01-23
Participant Flow
Participants were recruited based on referral at two academic medical centers in South Africa between July 2018 and June 2021. First participant was enrolled on 20 July 2018 and the last participant was enrolled in June 2021
A total of 52 participants met the inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Quadrivalent HPV Vaccine
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
24
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Quadrivalent HPV Vaccine
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Quadrivalent HPV Vaccine
n=28 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=24 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 9.96 • n=28 Participants
|
32.9 years
STANDARD_DEVIATION 10.27 • n=24 Participants
|
35.0 years
STANDARD_DEVIATION 10.3 • n=52 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=28 Participants
|
24 Participants
n=24 Participants
|
52 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Self-reported tobacco smoking
|
2 Participants
n=28 Participants
|
5 Participants
n=24 Participants
|
7 Participants
n=52 Participants
|
|
Self-reported medical diseases
|
7 Participants
n=28 Participants
|
10 Participants
n=24 Participants
|
17 Participants
n=52 Participants
|
|
HIV-positivity
|
25 Participants
n=28 Participants
|
21 Participants
n=24 Participants
|
46 Participants
n=52 Participants
|
|
White cell count
|
6.1 cells x 10^9/l
STANDARD_DEVIATION 1.95 • n=28 Participants
|
6.8 cells x 10^9/l
STANDARD_DEVIATION 2.38 • n=24 Participants
|
6.4 cells x 10^9/l
STANDARD_DEVIATION 2.18 • n=52 Participants
|
|
Haemoglobin
|
11.7 g/dl
STANDARD_DEVIATION 1.58 • n=28 Participants
|
12.1 g/dl
STANDARD_DEVIATION 1.31 • n=24 Participants
|
11.9 g/dl
STANDARD_DEVIATION 1.48 • n=52 Participants
|
|
Platelet count
|
323 cells x 10^9 /l
STANDARD_DEVIATION 99.2 • n=28 Participants
|
331 cells x 10^9 /l
STANDARD_DEVIATION 73.0 • n=24 Participants
|
327 cells x 10^9 /l
STANDARD_DEVIATION 88.4 • n=52 Participants
|
|
Alkaline phosphatase (blood test)
|
94 U/l
STANDARD_DEVIATION 21.1 • n=28 Participants
|
88 U/l
STANDARD_DEVIATION 26.5 • n=24 Participants
|
91 U/l
STANDARD_DEVIATION 23.9 • n=52 Participants
|
|
Alanine transaminase (blood test)
|
23 U/l
STANDARD_DEVIATION 14.6 • n=28 Participants
|
20 U/l
STANDARD_DEVIATION 7.8 • n=24 Participants
|
21 U/l
STANDARD_DEVIATION 12.0 • n=52 Participants
|
|
Bilirubin total
|
6.5 µmol/l
STANDARD_DEVIATION 4.2 • n=28 Participants
|
6.1 µmol/l
STANDARD_DEVIATION 4.4 • n=24 Participants
|
6.3 µmol/l
STANDARD_DEVIATION 4.3 • n=52 Participants
|
|
Total protein (blood test)
|
79 g/l
STANDARD_DEVIATION 6.6 • n=28 Participants
|
80 g/l
STANDARD_DEVIATION 6.9 • n=24 Participants
|
79 g/l
STANDARD_DEVIATION 6.7 • n=52 Participants
|
|
Serum sodium
|
138 mmol/l
STANDARD_DEVIATION 1.9 • n=28 Participants
|
138 mmol/l
STANDARD_DEVIATION 2.6 • n=24 Participants
|
138 mmol/l
STANDARD_DEVIATION 2.3 • n=52 Participants
|
|
Serum potassium
|
4.4 mmol/l
STANDARD_DEVIATION 0.77 • n=28 Participants
|
4.4 mmol/l
STANDARD_DEVIATION 0.95 • n=24 Participants
|
4.4 mmol/l
STANDARD_DEVIATION 0.86 • n=52 Participants
|
|
Serum chloride
|
106 mmol/l
STANDARD_DEVIATION 2.3 • n=28 Participants
|
105 mmol/l
STANDARD_DEVIATION 2.9 • n=24 Participants
|
106 mmol/l
STANDARD_DEVIATION 2.6 • n=52 Participants
|
|
Total serum carbon dioxide
|
22 mmol/l
STANDARD_DEVIATION 2.1 • n=28 Participants
|
23 mmol/l
STANDARD_DEVIATION 3.6 • n=24 Participants
|
23 mmol/l
STANDARD_DEVIATION 2.9 • n=52 Participants
|
|
Serum urea
|
3.2 mmol/l
STANDARD_DEVIATION 0.8 • n=28 Participants
|
3.7 mmol/l
STANDARD_DEVIATION 1.5 • n=24 Participants
|
3.4 mmol/l
STANDARD_DEVIATION 1.2 • n=52 Participants
|
|
Number of vulva lesions
1-5 lesions
|
7 Participants
n=28 Participants
|
5 Participants
n=24 Participants
|
12 Participants
n=52 Participants
|
|
Number of vulva lesions
6-10 lesions
|
6 Participants
n=28 Participants
|
7 Participants
n=24 Participants
|
13 Participants
n=52 Participants
|
|
Number of vulva lesions
11-15 lesions
|
7 Participants
n=28 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=52 Participants
|
|
Number of vulva lesions
15+ lesions
|
8 Participants
n=28 Participants
|
9 Participants
n=24 Participants
|
17 Participants
n=52 Participants
|
|
Diameter of largest vulva lesion
|
61 mm
STANDARD_DEVIATION 62 • n=28 Participants
|
81 mm
STANDARD_DEVIATION 184 • n=24 Participants
|
70 mm
STANDARD_DEVIATION 133 • n=52 Participants
|
|
Number of cervico-vaginal lesions (per category)
No visible lesion
|
10 Participants
n=28 Participants
|
12 Participants
n=24 Participants
|
22 Participants
n=52 Participants
|
|
Number of cervico-vaginal lesions (per category)
1-5 lesions
|
14 Participants
n=28 Participants
|
6 Participants
n=24 Participants
|
20 Participants
n=52 Participants
|
|
Number of cervico-vaginal lesions (per category)
6-10 lesions
|
1 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=52 Participants
|
|
Number of cervico-vaginal lesions (per category)
11-15 lesions
|
0 Participants
n=28 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=52 Participants
|
|
Number of cervico-vaginal lesions (per category)
15+ lesions
|
3 Participants
n=28 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=52 Participants
|
|
Diameter of largest cervico-vaginal lesion - estimated
|
15 mm
STANDARD_DEVIATION 10 • n=28 Participants
|
12 mm
STANDARD_DEVIATION 8 • n=24 Participants
|
14 mm
STANDARD_DEVIATION 9 • n=52 Participants
|
|
Cytology results (baseline)
Normal
|
9 Participants
n=28 Participants
|
5 Participants
n=24 Participants
|
14 Participants
n=52 Participants
|
|
Cytology results (baseline)
Atypical Squamous Cells of Undetermined Significance (ASCUS) [slightly abnormal]
|
0 Participants
n=28 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=52 Participants
|
|
Cytology results (baseline)
Low-Grade Squamous Intraepithelial Lesion (LSIL) [monitor for progression]
|
9 Participants
n=28 Participants
|
7 Participants
n=24 Participants
|
16 Participants
n=52 Participants
|
|
Cytology results (baseline)
High-Grade Squamous Intraepithelial Lesion (HSIL) [needs treatment]
|
10 Participants
n=28 Participants
|
10 Participants
n=24 Participants
|
20 Participants
n=52 Participants
|
|
Cervix HPV prevalence
High-risk HPV positive
|
23 Participants
n=28 Participants
|
16 Participants
n=24 Participants
|
39 Participants
n=52 Participants
|
|
Cervix HPV prevalence
Low-risk HPV positive
|
24 Participants
n=28 Participants
|
19 Participants
n=24 Participants
|
43 Participants
n=52 Participants
|
|
Vulvar HPV prevalence (baseline)
High-risk HPV positive
|
18 Participants
n=28 Participants
|
17 Participants
n=24 Participants
|
35 Participants
n=52 Participants
|
|
Vulvar HPV prevalence (baseline)
Low-risk HPV positive
|
25 Participants
n=28 Participants
|
21 Participants
n=24 Participants
|
46 Participants
n=52 Participants
|
|
Cervical histopathology (LLETZ biopsies)
Normal
|
0 Participants
n=8 Participants • Not all participants required LLETZ treatment
|
2 Participants
n=9 Participants • Not all participants required LLETZ treatment
|
2 Participants
n=17 Participants • Not all participants required LLETZ treatment
|
|
Cervical histopathology (LLETZ biopsies)
Cervical Intraepithelial Neoplasia Grade 2 (CIN2) [moderately abnormal cells, needs treatment]
|
0 Participants
n=8 Participants • Not all participants required LLETZ treatment
|
4 Participants
n=9 Participants • Not all participants required LLETZ treatment
|
4 Participants
n=17 Participants • Not all participants required LLETZ treatment
|
|
Cervical histopathology (LLETZ biopsies)
Cervical Intraepithelial Neoplasia Grade 3 (CIN3) [severely abnormal cells, needs treatment]
|
8 Participants
n=8 Participants • Not all participants required LLETZ treatment
|
3 Participants
n=9 Participants • Not all participants required LLETZ treatment
|
11 Participants
n=17 Participants • Not all participants required LLETZ treatment
|
|
Vulvar histopathology
Condylomata acuminata (genital warts - benign, better outcome)
|
14 Participants
n=28 Participants
|
12 Participants
n=24 Participants
|
26 Participants
n=52 Participants
|
|
Vulvar histopathology
Vulvar Intraepithelial Neoplasia Grade 1 (VIN1, better outcome) [needs monitoring]
|
2 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=52 Participants
|
|
Vulvar histopathology
Vulvar Intraepithelial Neoplasia grade 2 (VIN2, worse outcome) [needs treatment]
|
0 Participants
n=28 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=52 Participants
|
|
Vulvar histopathology
Vulvar Intraepithelial Neoplasia 3 (VIN3, worse outcome) [needs treatment]
|
10 Participants
n=28 Participants
|
8 Participants
n=24 Participants
|
18 Participants
n=52 Participants
|
|
Vulvar histopathology
Vulvar squamous cell carcinoma (worst outcome) [needs treatment]
|
4 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=52 Participants
|
|
Treatment type for vulvar lesions
Surgery and or cautery
|
19 Participants
n=28 Participants
|
20 Participants
n=24 Participants
|
39 Participants
n=52 Participants
|
|
Treatment type for vulvar lesions
Cryotherapy
|
1 Participants
n=28 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=52 Participants
|
|
Treatment type for vulvar lesions
Surgery followed by imiquimod
|
1 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=52 Participants
|
|
Treatment type for vulvar lesions
Imiquimod only
|
3 Participants
n=28 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=52 Participants
|
|
Treatment type for vulvar lesions
No treatment during trial
|
4 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 8, 24, 60Population: Some participants were lost to follow up after Week 28
The number of participants in whom the size of the genital wart lesion(s) measured smaller at Week8, Week24 and Week60 as compared to their baseline measurement (all measured in mm).
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=28 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=24 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
Week0 vs Week24
|
11 Participants
|
7 Participants
|
|
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
Week0 vs Week60
|
19 Participants
|
22 Participants
|
|
Change in the Maximum Size of the Genital Wart Lesion Over the Trial Period (as Measured in mm)
Week0 vs Week8
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 36+Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 72Population: Only participants who were positive for HPV6 at baseline were assessed for possible conversion to HPV6-negative at Week 72
The number of participants who change from HPV 6 DNA positive in warts to HPV 6 DNA negative at week 72
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=20 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=21 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72
Number of participants HPV6 positive at W0 (wart lesion)
|
10 Participants
|
9 Participants
|
|
Number of Participants Who Change From HPV 6 DNA Positive in Warts to Negative at Week 72
Number of participants who changed from HPV6 positive at W0 to HPV6 negative at Week72 (wart lesion)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 72Population: Only participants who were positive for HPV11 at baseline were assessed for possible conversion to HPV11-negative at Week 72
The number of participants who change from HPV 11 DNA positive in warts to negative at week 72
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=20 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=21 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72
Number of participants HPV11 positive at W0 (wart lesion)
|
7 Participants
|
11 Participants
|
|
Number of Participants Who Change From HPV 11 DNA Positive in Warts to Negative at Week 72
Number of participants who changed from HPV11 positive at W0 to HPV11 negative at W72 (wart lesion)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 60Population: Only participants who were positive for HPV16 at baseline were assessed for possible conversion to HPV16-negative at Week 60
The number of participants who change from HPV 16 DNA positive at baseline to negative at week 60
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=20 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=21 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60
Number of participants HPV16 positive at W0 (wart lesion)
|
8 Participants
|
7 Participants
|
|
Number of Participants Who Change From HPV 16 DNA Positive at Baseline to Negative at Week 60
Number of participants who changed from HPV16 positive at W0 to HPV16 negative at W60 (wart lesion)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 60Population: Only participants who were positive for HPV18 at baseline were assessed for possible conversion to HPV18-negative at Week 60
The number of participants who change from HPV 18 DNA positive at baseline to negative at week 60
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=20 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=21 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60
Number of participants HPV18 positive at W0 (wart lesion)
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Change From HPV 18 DNA Positive at Baseline to Negative at Week 60
Number of participants who changed from HPV18 positive at W0 to HPV18 negative at W60 (wart lesion)
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 48Population: Number of participants who change from HIV negative at baseline to positive at week 48. Only HIV-negative participants were assessed at Week 48.
The number of participants who change from HIV negative at baseline to positive at week 48
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=28 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=24 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Change From HIV Negative at Baseline to Positive at Week 48
Number of participants who were HIV-negative at baseline
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Change From HIV Negative at Baseline to Positive at Week 48
The number of participants who changed from HIV negative at baseline to HIV-positive at week 48
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24, 72The number of participants who require surgical treatment of warts at any of the clinical assessments during the trial, as judged by the attending clinician.
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=28 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=24 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Require Surgical Treatment of Warts at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.
Require surgical treatment of warts at W28
|
21 Participants
|
18 Participants
|
|
Number of Participants Who Require Surgical Treatment of Warts at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.
Require surgical treatment of warts at W72
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24, 72The number of participants who require surgical treatment of cervical disease at any of the clinical assessments during the trial, as judged by the attending clinician.
Outcome measures
| Measure |
Quadrivalent HPV Vaccine
n=28 Participants
Three doses of 4 HPV vaccine is given at registered intervals.
Quadrivalent HPV vaccine: Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
Hepatitis B Vaccine
n=24 Participants
Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.
Hepatitis B vaccine: Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
|
|---|---|---|
|
Number of Participants Who Require Surgical Treatment of Cervical Disease at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.
Need Large Loop Excision of the Transformation Zone (LLETZ) at Week24
|
10 Participants
|
10 Participants
|
|
Number of Participants Who Require Surgical Treatment of Cervical Disease at Any of the Clinical Assessments During the Trial, as Judged by the Attending Clinician.
Need Large Loop Excision of the Transformation Zone (LLETZ) at Week72
|
2 Participants
|
1 Participants
|
Adverse Events
Quadrivalent HPV Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hepatitis B Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60