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Trial record 1 of 1 for:    NCT01984697
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A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

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ClinicalTrials.gov Identifier: NCT01984697
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : April 26, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Human Papillomavirus Infection
Intervention Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Enrollment 1518
Recruitment Details  
Pre-assignment Details A total of 1536 participants were screened and 1518 were randomized into the study.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Period Title: Overall Study
Started 301 301 301 301 314
Vaccination 1 301 301 300 300 314
Vaccination 2 293 296 291 298 313
Vaccination 3 0 0 0 293 311
Month 36 Vaccination 270 281 280 9 31
Completed 258 270 272 280 279
Not Completed 43 31 29 21 35
Reason Not Completed
Adverse Event             0             0             2             0             0
Lost to Follow-up             14             5             10             6             21
Physician Decision             3             0             0             1             0
Protocol Violation             8             5             3             2             0
Withdrawal by Subject             15             21             13             11             13
Missed last follow-up visit             1             0             0             0             0
Death             0             0             0             1             0
Pregnancy             2             0             1             0             1
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6 Total
Hide Arm/Group Description Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Total of all reporting groups
Overall Number of Baseline Participants 301 301 301 301 314 1518
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 301 participants 301 participants 301 participants 314 participants 1518 participants
11.4  (1.7) 11.5  (1.7) 11.4  (1.6) 11.4  (1.7) 21.0  (2.7) 13.4  (4.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 301 participants 301 participants 301 participants 314 participants 1518 participants
Between 9 and 10 years 100 98 100 101 0 399
Between 11 and 12 years 102 102 106 100 0 410
Between 13 and 14 years 99 101 95 100 0 395
Between 16 and 26 years 0 0 0 0 314 314
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 301 participants 301 participants 301 participants 314 participants 1518 participants
Female
301
 100.0%
0
   0.0%
151
  50.2%
301
 100.0%
314
 100.0%
1067
  70.3%
Male
0
   0.0%
301
 100.0%
150
  49.8%
0
   0.0%
0
   0.0%
451
  29.7%
1.Primary Outcome
Title Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 258 263 257 254 238
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
1657.9
(1479.6 to 1857.6)
1557.4
(1391.5 to 1743.1)
2678.8
(2390.2 to 3002.1)
1496.1
(1334.1 to 1677.8)
770.9
(684.8 to 867.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
1.83 to 2.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
1.73 to 2.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.47
Confidence Interval (2-Sided) 95%
2.93 to 4.11
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 258 264 257 254 238
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
1388.9
(1240.4 to 1555.3)
1423.9
(1273.2 to 1592.3)
2941.8
(2626.6 to 3294.9)
1306.3
(1165.5 to 1464.0)
580.5
(516.0 to 653.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.39
Confidence Interval (2-Sided) 95%
2.03 to 2.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.45
Confidence Interval (2-Sided) 95%
2.09 to 2.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 5.07
Confidence Interval (2-Sided) 95%
4.32 to 5.94
Estimation Comments [Not Specified]
3.Primary Outcome
Title Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 273 264 269 249
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
8004.9
(7160.5 to 8948.8)
8474.8
(7582.4 to 9472.3)
14329.3
(12796.4 to 16045.9)
6996.0
(6254.1 to 7825.8)
3154.0
(2807.1 to 3543.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.54
Confidence Interval (2-Sided) 95%
2.14 to 3.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.69
Confidence Interval (2-Sided) 95%
2.29 to 3.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 4.54
Confidence Interval (2-Sided) 95%
3.84 to 5.37
Estimation Comments [Not Specified]
4.Primary Outcome
Title Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 272 266 270 267
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
1872.8
(1651.6 to 2123.6)
1860.9
(1641.1 to 2110.2)
2810.4
(2474.9 to 3191.3)
2049.3
(1806.4 to 2324.8)
761.5
(670.8 to 864.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.46
Confidence Interval (2-Sided) 95%
2.05 to 2.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.44
Confidence Interval (2-Sided) 95%
2.04 to 2.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.69
Confidence Interval (2-Sided) 95%
3.06 to 4.45
Estimation Comments [Not Specified]
5.Primary Outcome
Title Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 271 268 271 264
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
1436.3
(1272.1 to 1621.8)
1498.2
(1326.5 to 1692.0)
2117.5
(1873.7 to 2393.1)
1748.3
(1548.1 to 1974.5)
572.1
(505.8 to 647.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.51
Confidence Interval (2-Sided) 95%
2.10 to 3.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.62
Confidence Interval (2-Sided) 95%
2.20 to 3.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.70
Confidence Interval (2-Sided) 95%
3.08 to 4.45
Estimation Comments [Not Specified]
6.Primary Outcome
Title Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 273 271 269 275 279
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
1030.0
(920.4 to 1152.7)
1040.0
(928.9 to 1164.3)
2197.5
(1961.9 to 2461.3)
796.4
(712.0 to 890.9)
348.1
(311.5 to 389.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.96
Confidence Interval (2-Sided) 95%
2.50 to 3.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.99
Confidence Interval (2-Sided) 95%
2.55 to 3.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 6.31
Confidence Interval (2-Sided) 95%
5.36 to 7.43
Estimation Comments [Not Specified]
7.Primary Outcome
Title Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 274 273 268 275 280
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
357.6
(313.7 to 407.6)
352.3
(309.0 to 401.7)
417.7
(365.9 to 476.9)
661.7
(580.6 to 754.1)
213.6
(187.7 to 243.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
1.38 to 2.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
1.37 to 1.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
1.61 to 2.37
Estimation Comments [Not Specified]
8.Primary Outcome
Title Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 273 268 275 271
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
581.1
(521.9 to 647.1)
640.4
(575.2 to 713.0)
1123.4
(1008.1 to 1251.9)
909.9
(817.6 to 1012.5)
364.2
(327.0 to 405.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.36 to 1.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.51 to 2.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.08
Confidence Interval (2-Sided) 95%
2.64 to 3.61
Estimation Comments [Not Specified]
9.Primary Outcome
Title Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 270 270 265 273 261
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
1251.2
(1119.6 to 1398.4)
1325.7
(1186.2 to 1481.6)
2444.6
(2185.2 to 2734.9)
1229.3
(1100.7 to 1373.0)
491.1
(438.6 to 549.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.55
Confidence Interval (2-Sided) 95%
2.15 to 3.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.70
Confidence Interval (2-Sided) 95%
2.30 to 3.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 4.98
Confidence Interval (2-Sided) 95%
4.23 to 5.86
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 258 263 257 254 238
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.6
(97.9 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
99.2
(97.2 to 99.9)
99.6
(97.7 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.8 to 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.1 to 2.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 258 264 257 254 238
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(98.6 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
99.6
(97.8 to 100)
99.6
(97.7 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.1 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.1 to 2.3
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 273 264 269 249
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(98.7 to 100)
100
(98.7 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
99.6
(97.8 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.2
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 272 266 270 267
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(98.7 to 100)
100
(98.7 to 100)
100
(98.6 to 100)
99.6
(98.0 to 100)
98.5
(96.2 to 99.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.1 to 3.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.1 to 3.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.1 to 3.8
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 271 268 271 264
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.6
(98.0 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
99.6
(97.9 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.7 to 1.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.1
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 273 271 269 275 279
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.6
(98.0 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
100
(98.7 to 100)
99.6
(98.0 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.7 to 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.1 to 2.0
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 274 273 268 275 280
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.3
(97.4 to 99.9)
99.3
(97.4 to 99.9)
100
(98.6 to 100)
99.3
(97.4 to 99.9)
97.9
(95.4 to 99.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-0.7 to 4.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-0.7 to 4.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
0.7 to 4.6
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 272 273 268 275 271
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.6
(98.0 to 100)
100
(98.7 to 100)
100
(98.6 to 100)
99.6
(98.0 to 100)
99.6
(98.0 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.7 to 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Hide Description Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.
Time Frame 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 270 270 265 273 261
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100
(98.6 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
99.6
(98.0 to 100)
99.6
(97.9 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Girls 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boys 9 to 14 Years V503 at Months 0 and 6, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.0 to 2.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments One-sided non-inferiority test at alpha=0.025 level
Method of Estimation Estimation Parameter Seroconversion percentage difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.1 to 2.1
Estimation Comments [Not Specified]
19.Other Pre-specified Outcome
Title Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Hide Description Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 301 301 300 300 314
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
Anti-HPV Type 6 Number Analyzed 253 participants 259 participants 252 participants 249 participants 232 participants
260.7
(231.5 to 293.6)
209.1
(185.9 to 235.1)
574.0
(509.6 to 646.5)
300.7
(266.8 to 339.0)
153.2
(135.4 to 173.5)
Anti-HPV Type 11 Number Analyzed 253 participants 260 participants 252 participants 249 participants 232 participants
169.8
(150.5 to 191.7)
150.6
(133.6 to 169.7)
443.7
(392.9 to 501.0)
201.9
(178.7 to 228.1)
98.3
(86.6 to 111.6)
Anti-HPV Type 16 Number Analyzed 266 participants 269 participants 259 participants 264 participants 241 participants
900.5
(788.0 to 1028.9)
801.0
(701.5 to 914.6)
2316.2
(2023.5 to 2651.4)
1041.3
(910.8 to 1190.4)
461.6
(401.2 to 531.0)
Anti-HPV Type 18 Number Analyzed 266 participants 268 participants 261 participants 265 participants 259 participants
196.8
(174.9 to 221.6)
169.6
(150.7 to 190.8)
380.8
(337.9 to 429.1)
255.8
(227.2 to 288.0)
122.2
(108.4 to 137.7)
Anti-HPV Type 31 Number Analyzed 266 participants 267 participants 263 participants 266 participants 258 participants
160.6
(140.8 to 183.3)
139.1
(122.0 to 158.7)
312.8
(273.9 to 357.1)
260.6
(228.4 to 297.3)
89.6
(78.4 to 102.5)
Anti-HPV Type 33 Number Analyzed 267 participants 267 participants 264 participants 270 participants 269 participants
131.2
(116.9 to 147.2)
121.5
(108.3 to 136.4)
341.7
(304.3 to 383.6)
120.8
(107.7 to 135.4)
61.3
(54.6 to 68.7)
Anti-HPV Type 45 Number Analyzed 268 participants 269 participants 263 participants 270 participants 271 participants
37.8
(33.2 to 43.0)
31.9
(28.0 to 36.3)
62.3
(54.7 to 71.1)
86.9
(76.4 to 98.9)
30.7
(27.0 to 34.9)
Anti-HPV Type 52 Number Analyzed 266 participants 269 participants 263 participants 270 participants 261 participants
85.1
(76.4 to 94.7)
80.9
(72.7 to 90.0)
199.4
(179.0 to 222.2)
150.4
(135.2 to 167.4)
73.7
(66.1 to 82.1)
Anti-HPV Type 58 Number Analyzed 264 participants 266 participants 260 participants 268 participants 253 participants
155.4
(138.0 to 175.1)
149.8
(133.1 to 168.6)
380.2
(337.3 to 428.6)
183.7
(163.3 to 206.7)
76.8
(68.0 to 86.7)
20.Other Pre-specified Outcome
Title Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24
Hide Description Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 301 301 300 300 314
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Anti-HPV Type 6 Number Analyzed 253 participants 259 participants 252 participants 249 participants 232 participants
98.4
(96.0 to 99.6)
96.9
(94.0 to 98.7)
99.2
(97.2 to 99.9)
99.6
(97.8 to 100)
94.0
(90.1 to 96.7)
Anti-HPV Type 11 Number Analyzed 253 participants 260 participants 252 participants 249 participants 232 participants
98.0
(95.4 to 99.4)
95.8
(92.6 to 97.9)
99.6
(97.8 to 100)
98.8
(96.5 to 99.8)
94.8
(91.1 to 97.3)
Anti-HPV Type 16 Number Analyzed 266 participants 269 participants 259 participants 264 participants 241 participants
98.9
(96.7 to 99.8)
99.6
(97.9 to 100)
100
(98.6 to 100)
99.6
(97.9 to 100)
99.6
(97.7 to 100)
Anti-HPV Type 18 Number Analyzed 266 participants 268 participants 261 participants 265 participants 259 participants
98.5
(96.2 to 99.6)
95.9
(92.8 to 97.9)
98.9
(96.7 to 99.8)
99.2
(97.3 to 99.9)
95.0
(91.6 to 97.3)
Anti-HPV Type 31 Number Analyzed 266 participants 267 participants 263 participants 266 participants 258 participants
97.0
(94.2 to 98.7)
94.8
(91.4 to 97.1)
98.5
(96.2 to 99.6)
97.7
(95.2 to 99.2)
91.5
(87.4 to 94.6)
Anti-HPV Type 33 Number Analyzed 267 participants 267 participants 264 participants 270 participants 269 participants
97.8
(95.2 to 99.2)
96.6
(93.7 to 98.4)
99.2
(97.3 to 99.9)
98.9
(96.8 to 99.8)
94.8
(91.4 to 97.1)
Anti-HPV Type 45 Number Analyzed 268 participants 269 participants 263 participants 270 participants 271 participants
88.4
(84.0 to 92.0)
85.9
(81.1 to 89.8)
93.9
(90.3 to 96.5)
96.7
(93.8 to 98.5)
82.7
(77.6 to 87.0)
Anti-HPV Type 52 Number Analyzed 266 participants 269 participants 263 participants 270 participants 261 participants
96.6
(93.7 to 98.4)
95.2
(91.9 to 97.4)
99.2
(97.3 to 99.9)
99.3
(97.3 to 99.9)
97.3
(94.6 to 98.9)
Anti-HPV Type 58 Number Analyzed 264 participants 266 participants 260 participants 268 participants 253 participants
98.9
(96.7 to 99.8)
99.6
(97.9 to 100)
100
(98.6 to 100)
100
(98.6 to 100)
96.0
(92.9 to 98.1)
21.Other Pre-specified Outcome
Title Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Hide Description Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 301 301 300 300 314
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
Anti-HPV Type 6 Number Analyzed 236 participants 254 participants 246 participants 240 participants 214 participants
209.6
(184.9 to 237.6)
160.1
(141.9 to 180.7)
401.2
(354.8 to 453.7)
232.2
(205.1 to 263.0)
133.8
(117.3 to 152.7)
Anti-HPV Type 11 Number Analyzed 236 participants 255 participants 246 participants 240 participants 214 participants
133.7
(117.6 to 152.1)
115.2
(101.8 to 130.3)
308.2
(271.8 to 349.6)
159.1
(140.0 to 180.7)
82.9
(72.4 to 94.9)
Anti-HPV Type 16 Number Analyzed 248 participants 263 participants 253 participants 255 participants 222 participants
673.8
(582.8 to 779.1)
592.6
(514.7 to 682.4)
1534.3
(1328.8 to 1771.5)
792.4
(686.7 to 914.4)
368.9
(316.4 to 430.0)
Anti-HPV Type 18 Number Analyzed 248 participants 262 participants 255 participants 256 participants 239 participants
158.9
(140.8 to 179.4)
141.7
(125.9 to 159.4)
276.4
(245.3 to 311.6)
206.5
(183.3 to 232.7)
104.1
(92.0 to 117.8)
Anti-HPV Type 31 Number Analyzed 248 participants 261 participants 257 participants 258 participants 235 participants
127.8
(111.4 to 146.5)
106.9
(93.5 to 122.1)
218.0
(190.6 to 249.4)
205.9
(180.0 to 235.5)
74.6
(64.8 to 85.9)
Anti-HPV Type 33 Number Analyzed 249 participants 261 participants 258 participants 261 participants 246 participants
106.0
(94.1 to 119.5)
95.7
(85.1 to 107.5)
240.4
(213.8 to 270.3)
95.5
(85.0 to 107.3)
52.2
(46.3 to 58.9)
Anti-HPV Type 45 Number Analyzed 250 participants 263 participants 257 participants 261 participants 248 participants
30.6
(26.9 to 35.0)
26.8
(23.6 to 30.4)
43.6
(38.3 to 49.7)
66.1
(58.1 to 75.2)
27.3
(23.9 to 31.1)
Anti-HPV Type 52 Number Analyzed 248 participants 263 participants 257 participants 261 participants 239 participants
66.2
(59.1 to 74.0)
63.4
(56.8 to 70.7)
143.2
(128.3 to 159.9)
115.9
(103.9 to 129.3)
61.5
(54.8 to 68.9)
Anti-HPV Type 58 Number Analyzed 246 participants 261 participants 255 participants 259 participants 231 participants
125.8
(111.1 to 142.5)
119.2
(105.6 to 134.5)
265.3
(234.8 to 299.8)
143.0
(126.7 to 161.5)
64.7
(56.9 to 73.6)
22.Other Pre-specified Outcome
Title Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36
Hide Description Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description:
Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Overall Number of Participants Analyzed 301 301 300 300 314
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Anti-HPV Type 6 Number Analyzed 236 participants 254 participants 246 participants 240 participants 214 participants
95.3
(91.8 to 97.7)
91.3
(87.2 to 94.5)
99.2
(97.1 to 99.9)
97.9
(95.2 to 99.3)
92.1
(87.6 to 95.3)
Anti-HPV Type 11 Number Analyzed 236 participants 255 participants 246 participants 240 participants 214 participants
94.1
(90.2 to 96.7)
92.9
(89.1 to 95.8)
99.2
(97.1 to 99.9)
98.8
(96.4 to 99.7)
92.1
(87.6 to 95.3)
Anti-HPV Type 16 Number Analyzed 248 participants 263 participants 253 participants 255 participants 222 participants
97.2
(94.3 to 98.9)
98.5
(96.2 to 99.6)
100
(98.6 to 100)
99.2
(97.2 to 99.9)
98.2
(95.5 to 99.5)
Anti-HPV Type 18 Number Analyzed 248 participants 262 participants 255 participants 256 participants 239 participants
95.6
(92.2 to 97.8)
94.3
(90.7 to 96.8)
97.6
(94.9 to 99.1)
97.3
(94.4 to 98.9)
90.8
(86.4 to 94.1)
Anti-HPV Type 31 Number Analyzed 248 participants 261 participants 257 participants 258 participants 235 participants
94.0
(90.2 to 96.6)
91.2
(87.1 to 94.3)
96.5
(93.5 to 98.4)
97.7
(95.0 to 99.1)
86.0
(80.8 to 90.1)
Anti-HPV Type 33 Number Analyzed 249 participants 261 participants 258 participants 261 participants 246 participants
94.0
(90.3 to 96.6)
96.9
(94.1 to 98.7)
99.2
(97.2 to 99.9)
98.1
(95.6 to 99.4)
91.9
(87.7 to 95.0)
Anti-HPV Type 45 Number Analyzed 250 participants 263 participants 257 participants 261 participants 248 participants
83.6
(78.4 to 88.0)
81.4
(76.1 to 85.9)
87.9
(83.3 to 91.7)
91.2
(87.1 to 94.3)
77.8
(72.1 to 82.8)
Anti-HPV Type 52 Number Analyzed 248 participants 263 participants 257 participants 261 participants 239 participants
93.5
(89.7 to 96.3)
93.9
(90.3 to 96.5)
98.8
(96.6 to 99.8)
97.7
(95.1 to 99.2)
95.0
(91.4 to 97.4)
Anti-HPV Type 58 Number Analyzed 246 participants 261 participants 255 participants 259 participants 231 participants
98.0
(95.3 to 99.3)
99.2
(97.3 to 99.9)
100
(98.6 to 100)
98.8
(96.7 to 99.8)
94.8
(91.1 to 97.3)
Time Frame Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination
Adverse Event Reporting Description Participants at risk for adverse events includes those who were vaccinated and had safety follow-up data
 
Arm/Group Title Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Hide Arm/Group Description Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
All-Cause Mortality
Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/294 (0.00%)      0/296 (0.00%)      0/293 (0.00%)      1/300 (0.33%)      0/313 (0.00%)    
Hide Serious Adverse Events
Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/294 (2.04%)      9/296 (3.04%)      6/293 (2.05%)      6/300 (2.00%)      11/313 (3.51%)    
Cardiac disorders           
Cardiac arrest  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Wolff-Parkinson-White syndrome  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  2/294 (0.68%)  2 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
Diarrhoea  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
Gastritis  1  0/294 (0.00%)  0 0/296 (0.00%)  0 1/293 (0.34%)  1 0/300 (0.00%)  0 0/313 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis acute  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
Infections and infestations           
Appendicitis  1  1/294 (0.34%)  1 1/296 (0.34%)  1 1/293 (0.34%)  1 1/300 (0.33%)  1 0/313 (0.00%)  0
Dengue fever  1  1/294 (0.34%)  1 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Gastroenteritis rotavirus  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Pharyngitis  1  1/294 (0.34%)  1 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Pharyngotonsillitis  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
Subcutaneous abscess  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Chikungunya virus infection  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Meningitis bacterial  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Oral herpes  1  0/294 (0.00%)  0 0/296 (0.00%)  0 1/293 (0.34%)  1 0/300 (0.00%)  0 0/313 (0.00%)  0
Pneumonia  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Injury, poisoning and procedural complications           
Animal bite  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Concussion  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Forearm fracture  1  0/294 (0.00%)  0 0/296 (0.00%)  0 1/293 (0.34%)  1 0/300 (0.00%)  0 0/313 (0.00%)  0
Foreign body  1  1/294 (0.34%)  1 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Spinal fracture  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Papillary thyroid cancer  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Nervous system disorders           
Epilepsy  1  0/294 (0.00%)  0 1/296 (0.34%)  1 0/293 (0.00%)  0 0/300 (0.00%)  0 0/313 (0.00%)  0
Encephalitis autoimmune  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Radiculopathy  1  0/294 (0.00%)  0 0/296 (0.00%)  0 1/293 (0.34%)  1 0/300 (0.00%)  0 0/313 (0.00%)  0
Status epilepticus  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Premature delivery  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
Psychiatric disorders           
Depression  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Reproductive system and breast disorders           
Ovarian cyst  1  1/294 (0.34%)  1 0/296 (0.00%)  0 0/293 (0.00%)  0 1/300 (0.33%)  1 0/313 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatitis atopic  1  0/294 (0.00%)  0 0/296 (0.00%)  0 1/293 (0.34%)  1 0/300 (0.00%)  0 0/313 (0.00%)  0
Surgical and medical procedures           
Abortion induced  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 4/313 (1.28%)  4
Vascular disorders           
Venous thrombosis limb  1  0/294 (0.00%)  0 0/296 (0.00%)  0 0/293 (0.00%)  0 0/300 (0.00%)  0 1/313 (0.32%)  1
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Girls 9 to 14 Years V503 at Months 0 and 6 Boys 9 to 14 Years V503 at Months 0 and 6 Girls and Boys 9 to 14 Years V503 at Months 0 and 12 Girls 9 to 14 Years V503 at Months 0, 2, and 6 Young Women 16 to 26 Years V503 at Months 0, 2, and 6
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/294 (18.03%)      32/296 (10.81%)      46/293 (15.70%)      55/300 (18.33%)      90/313 (28.75%)    
General disorders           
Injection site pain  1  49/294 (16.67%)  65 28/296 (9.46%)  31 41/293 (13.99%)  52 53/300 (17.67%)  81 80/313 (25.56%)  148
Nervous system disorders           
Headache  1  8/294 (2.72%)  9 9/296 (3.04%)  9 7/293 (2.39%)  8 7/300 (2.33%)  8 16/313 (5.11%)  19
1
Term from vocabulary, MedDRA version 20.0
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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01984697    
Other Study ID Numbers: V503-010
2013-001314-15 ( EudraCT Number )
V503-010 ( Other Identifier: Merck Protocol Number )
First Submitted: November 8, 2013
First Posted: November 15, 2013
Results First Submitted: March 23, 2016
Results First Posted: April 26, 2016
Last Update Posted: August 8, 2018