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Trial record 33 of 197 for:    Vaginal Cancer: Clinical Trials

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

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ClinicalTrials.gov Identifier: NCT00943722
Recruitment Status : Active, not recruiting
First Posted : July 22, 2009
Results First Posted : January 13, 2015
Last Update Posted : October 16, 2017
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
Conditions Cervical Cancers
Vulvar Cancer
Vaginal Cancer
Genital Lesions
PAP Test Abnormalities
HPV Infections
Intervention Biological: V503
Enrollment 3074
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 9- to 15-Year-Old Females (Lot 1) 9- to 15-Year-Old Females (Lot 2) 9- to 15-Year-Old Females (Lot 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description 9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Period Title: Overall Study
Started 648 643 644 669 470
Vaccination 1 646 642 644 666 468
Vaccination 2 637 633 638 658 462
Vaccination 3 635 627 637 653 455
Completed 623 621 631 647 448 [1]
Not Completed 25 22 13 22 22
Reason Not Completed
Adverse Event             0             0             0             1             0
Lost to Follow-up             12             8             10             8             11
Physician Decision             1             0             0             0             1
Pregnancy             0             0             1             0             0
Protocol Violation             0             1             0             0             2
Withdrawal by Subject             12             13             2             13             8
[1]
Includes 4 participants for whom completion status is unknown
Arm/Group Title 9- to 15-Year-Old Females (Lot 1) 9- to 15-Year-Old Females (Lot 2) 9- to 15-Year-Old Females (Lot 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1) Total
Hide Arm/Group Description 9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. Total of all reporting groups
Overall Number of Baseline Participants 648 643 644 669 470 3074
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 648 participants 643 participants 644 participants 669 participants 470 participants 3074 participants
9 to 12 years 440 432 432 450 0 1754
13 to 15 years 208 211 212 219 0 850
16 to 26 years 0 0 0 0 470 470
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 648 participants 643 participants 644 participants 669 participants 470 participants 3074 participants
Female
648
 100.0%
643
 100.0%
644
 100.0%
0
   0.0%
470
 100.0%
2405
  78.2%
Male
0
   0.0%
0
   0.0%
0
   0.0%
669
 100.0%
0
   0.0%
669
  21.8%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Hide Description Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.
Time Frame 4 weeks post-vaccination 3 (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Arm/Group Title 9- to 15-Year-Old Females (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 535 378
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli Merck Units/mL
Anti-HPV 6 (n=517; 328)
1715.4
(1595.1 to 1844.7)
900.8
(822.3 to 986.9)
Anti-HPV 11 (n=517; 332)
1295.1
(1204.1 to 1393.0)
706.6
(645.2 to 773.8)
Anti-HPV 16 (n=529; 329)
6979.8
(6508.1 to 7485.8)
3522.6
(3223.5 to 3849.5)
Anti-HPV 18 (n=531; 345)
2153.7
(1980.4 to 2342.1)
882.7
(795.4 to 979.5)
Anti-HPV 31 (n=522; 340)
1891.6
(1745.7 to 2049.7)
753.9
(682.5 to 832.7)
Anti-HPV 33 (n=534; 354)
980.4
(911.7 to 1054.3)
466.8
(426.9 to 510.3)
Anti-HPV 45 (n=534; 368)
714.4
(651.9 to 782.8)
272.2
(243.8 to 303.9)
Anti-HPV 52 (n=533; 337)
932.9
(864.8 to 1006.4)
419.6
(381.4 to 461.5)
Anti-HPV 58 (n=531; 332)
1286.7
(1195.7 to 1384.6)
590.5
(538.2 to 647.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
1.70 to 2.14
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
1.63 to 2.06
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.98
Confidence Interval (2-Sided) 95%
1.77 to 2.22
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.44
Confidence Interval (2-Sided) 95%
2.13 to 2.80
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.51
Confidence Interval (2-Sided) 95%
2.21 to 2.85
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.10
Confidence Interval (2-Sided) 95%
1.87 to 2.36
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.62
Confidence Interval (2-Sided) 95%
2.27 to 3.03
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
1.97 to 2.51
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
1.93 to 2.45
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
2.Primary Outcome
Title GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Hide Description Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.
Time Frame 4 weeks post-vaccination 3 (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Arm/Group Title 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 570 378
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli Merck Units/mL
Anti-HPV 6 (n=559; 328)
2084.7
(1944.0 to 2235.7)
900.8
(822.3 to 986.9)
Anti-HPV 11 (n=559; 332)
1487.1
(1386.5 to 1595.0)
706.6
(645.2 to 773.8)
Anti-HPV 16 (n=569; 329)
8628.9
(8065.9 to 9231.3)
3522.6
(3223.5 to 3849.5)
Anti-HPV 18 (n=567; 345)
2822.8
(2602.8 to 3061.5)
882.7
(795.4 to 979.5)
Anti-HPV 31 (n=564; 340)
2221.2
(2056.1 to 2399.5)
753.9
(682.5 to 832.7)
Anti-HPV 33 (n=567; 354)
1198.7
(1117.1 to 1286.2)
466.8
(426.9 to 510.3)
Anti-HPV 45 (n=570; 368)
907.0
(830.2 to 991.0)
272.2
(243.8 to 303.9)
Anti-HPV 52 (n=568; 337)
1037.8
(964.4 to 1116.9)
419.6
(381.4 to 461.5)
Anti-HPV 58 (n=566; 332)
1567.7
(1460.2 to 1683.1)
590.5
(538.2 to 647.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.31
Confidence Interval (2-Sided) 95%
2.07 to 2.59
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.10
Confidence Interval (2-Sided) 95%
1.88 to 2.36
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.45
Confidence Interval (2-Sided) 95%
2.19 to 2.74
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 3.20
Confidence Interval (2-Sided) 95%
2.80 to 3.65
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.95
Confidence Interval (2-Sided) 95%
2.60 to 3.34
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.57
Confidence Interval (2-Sided) 95%
2.29 to 2.88
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 3.33
Confidence Interval (2-Sided) 95%
2.89 to 3.84
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.47
Confidence Interval (2-Sided) 95%
2.19 to 2.79
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Statistical Test of Hypothesis P-Value <0.001
Comments one-sided tests of non-inferiority conducted at the alpha=0.025 level
Method ANOVA
Comments model with a response of log individual titers and a fixed effect for comparison group
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.66
Confidence Interval (2-Sided) 95%
2.37 to 2.98
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
3.Primary Outcome
Title GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Hide Description Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.
Time Frame 4 weeks post-vaccination 3 (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Arm/Group Title 9- to 15-Year-Old Females (Lot 1) 9- to 15-Year-Old Females (Lot 2) 9- to 15-Year-Old Females (Lot 3)
Hide Arm/Group Description:
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
Overall Number of Participants Analyzed 535 549 565
Geometric Mean (95% Confidence Interval)
Unit of Measure: milli Merck Units/mL
Anti-HPV 6 (n=517; 536; 544)
1715.4
(1588.7 to 1852.2)
1763.3
(1635.4 to 1901.3)
1659.9
(1540.3 to 1788.7)
Anti-HPV 11 (n=517; 536; 544)
1295.1
(1197.8 to 1400.3)
1311.7
(1214.9 to 1416.3)
1232.0
(1141.7 to 1329.5)
Anti-HPV 16 (n=529; 542; 556)
6979.8
(6476.1 to 7522.8)
7292.9
(6772.7 to 7853.1)
6948.2
(6458.7 to 7474.9)
Anti-HPV 18 (n=531; 547; 563)
2153.7
(1970.9 to 2353.5)
2134.1
(1955.6 to 2329.0)
1966.6
(1804.3 to 2143.5)
Anti-HPV 31 (n=522; 542; 553)
1891.6
(1738.5 to 2058.2)
1867.8
(1719.3 to 2029.1)
1879.0
(1731.0 to 2039.6)
Anti-HPV 33 (n=534; 543; 560)
980.4
(909.2 to 1057.2)
922.7
(856.2 to 994.4)
931.1
(865.0 to 1002.3)
Anti-HPV 45 (n=534; 548; 565)
714.4
(650.1 to 785.0)
827.7
(754.1 to 908.5)
678.4
(619.0 to 743.6)
Anti-HPV 52 (n=533; 547; 562)
932.9
(860.8 to 1011.0)
1007.9
(931.0 to 1091.2)
971.2
(898.1 to 1050.3)
Anti-HPV 58 (n=531; 539; 560)
1286.7
(1190.0 to 1391.3)
1344.9
(1244.6 to 1453.3)
1208.1
(1119.6 to 1303.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.88 to 1.08
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.93 to 1.16
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.95 to 1.19
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.90 to 1.11
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.95 to 1.20
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.95 to 1.20
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.86 to 1.06
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.90 to 1.12
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.94 to 1.17
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.89 to 1.14
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.98 to 1.26
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.97 to 1.26
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.89 to 1.13
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.91 to 1.16
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.90 to 1.15
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.94 to 1.16
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.94 to 1.17
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.90 to 1.12
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.73 to 0.95
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.91 to 1.18
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
1.08 to 1.42
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.83 to 1.03
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.85 to 1.07
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.92 to 1.16
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.86 to 1.06
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.96 to 1.20
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments model with a response of the natural log of individual titers and fixed effects for vaccine lot and age strata
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1.00 to 1.26
Estimation Comments GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
4.Primary Outcome
Title Percentage of Participants With Injection Site Adverse Experiences (AEs)
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Time Frame up to 5 days after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.
Arm/Group Title 9- to 15-Year-Old Females (Lots 1, 2 or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 1923 662 466
Measure Type: Number
Unit of Measure: Percentage of Participants
81.9 72.8 85.4
5.Primary Outcome
Title Percentage of Participants With Systemic AEs
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Time Frame up to 15 days after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.
Arm/Group Title 9- to 15-Year-Old Females (Lots 1, 2 or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 1923 662 466
Measure Type: Number
Unit of Measure: Percentage of Participants
45.0 41.8 57.1
6.Primary Outcome
Title Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
Hide Description Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
Time Frame up to 5 days after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.
Arm/Group Title 9- to 15-Year-Old Females (Lots 1, 2, or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 1908 660 463
Measure Type: Number
Unit of Measure: Percentage of Participants
8.4 10.0 8.4
7.Secondary Outcome
Title Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Hide Description Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Time Frame 4 weeks post-vaccination 3 (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Arm/Group Title 9- to 15-Year-Old Females (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 535 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Anti-HPV 6 cLIA ≥30 mMU/mL (n=517; 328)
99.8
(98.9 to 100)
99.7
(98.3 to 100)
Anti-HPV 11 cLIA ≥16 mMU/mL (n=517; 332)
100
(99.3 to 100.0)
100
(98.9 to 100.0)
Anti-HPV 16 cLIA ≥20 mMU/mL (n=529; 329)
100
(99.3 to 100.0)
100
(98.9 to 100.0)
Anti-HPV 18 cLIA ≥24 mMU/mL (n=531; 345)
99.8
(99.0 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 31 cLIA ≥10 mMU/mL (n=522; 340)
100.0
(99.3 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 33 cLIA ≥8 mMU/mL (n=534; 354)
100.0
(99.3 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 45 cLIA ≥8 mMU/mL (n=534; 368)
99.8
(99.0 to 100.0)
99.5
(98.1 to 99.9)
Anti-HPV 52 cLIA ≥8 mMU/mL (n=533; 337)
100.0
(99.3 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 58 cLIA ≥8 mMU/mL (n=531; 332)
100.0
(99.3 to 100.0)
100.0
(98.9 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.8 to 1.5
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 1.2
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 1.2
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.8 to 1.5
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.6
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.6 to 1.8
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.7
Estimation Comments 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 1.2
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
8.Secondary Outcome
Title Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Hide Description Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Time Frame 4 weeks post-vaccination 3 (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Arm/Group Title 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description:
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Overall Number of Participants Analyzed 570 378
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Anti-HPV 6 cLIA ≥30 mMU/mL (n=559; 328)
99.8
(99.0 to 100.0)
99.7
(98.3 to 100.0)
Anti-HPV 11 cLIA ≥16 mMU/mL (n=559; 332)
100.0
(99.3 to 100.0)
100.0
(98.9 to 100.0)
Anti-HPV 16 cLIA ≥20 mMU/mL (n=569; 329)
100.0
(99.4 to 100.0)
100.0
(98.9 to 100.0)
Anti-HPV 18 cLIA ≥24 mMU/mL (n=567; 345)
100.0
(99.4 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 31 cLIA ≥10 mMU/mL (n=564; 340)
100.0
(99.3 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 33 cLIA ≥8 mMU/mL (n=567; 354)
100.0
(99.4 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 45 cLIA ≥8 mMU/mL (n=570; 368)
100.0
(99.4 to 100.0)
99.5
(98.1 to 99.9)
Anti-HPV 52 cLIA ≥8 mMU/mL (n=568; 337)
100.0
(99.4 to 100.0)
99.7
(98.4 to 100.0)
Anti-HPV 58 cLIA ≥8 mMU/mL (n=566; 332)
100.0
(99.4 to 100.0)
100.0
(98.9 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.7 to 1.5
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 1.2
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 1.2
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.6
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.6
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.1 to 2.0
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Males (Lot 1), 16- to 26-Year-Old Females (Lot 1)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 1.2
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
9.Secondary Outcome
Title Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Hide Description Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Time Frame 4 weeks post-vaccination 3 (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Arm/Group Title 9- to 15-Year-Old Females (Lot 1) 9- to 15-Year-Old Females (Lot 2) 9- to 15-Year-Old Females (Lot 3)
Hide Arm/Group Description:
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
Overall Number of Participants Analyzed 535 549 565
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
HPV 6 cLIA ≥30 mMU/mL(n=517; 536; 544)
99.8
(98.9 to 100.0)
99.8
(99.0 to 100.0)
99.3
(98.1 to 99.8)
HPV 11 cLIA ≥16 mMU/mL (n=517; 536; 544)
100.0
(99.3 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
HPV 16 cLIA ≥20 mMU/mL (n= 529; 542; 556)
100.0
(99.3 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
HPV 18 cLIA ≥24 mMU/mL (n= 531; 547; 563)
99.8
(99.0 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
HPV 31 cLIA ≥10 mMU/mL (n=522; 542; 553)
100.0
(99.3 to 100.0)
100.0
(99.3 to 100.0)
99.8
(99.0 to 100.0)
HPV 33 cLIA ≥8 mMU/mL (534; 543; 560)
100.0
(99.3 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
HPV 45 cLIA ≥8 mMU/mL (n= 534; 548; 565)
99.8
(99.0 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
HPV 52 cLIA ≥8 mMU/mL (n=533; 547; 562)
100.0
(99.3 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
HPV 58 cLIA ≥8 mMU/mL (n=531; 539; 560)
100.0
(99.3 to 100.0)
100.0
(99.3 to 100.0)
99.6
(98.7 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.9 to 0.9
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.4 to 1.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 6
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.4 to 1.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 11
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 16
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.1 to 0.5
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.7 to 1.1
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 18
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.6 to 1.0
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 31
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.5 to 1.0
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 33
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.1 to 0.5
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.7 to 1.1
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 45
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 52
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.7 to 0.7
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3)
Comments Anti-HPV 58
Type of Statistical Test Non-Inferiority or Equivalence
Comments equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments stratified by age strata using Cochran–Mantel–Haenszel (CMH) weight
Method of Estimation Estimation Parameter Percentage Point Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.4 to 1.3
Estimation Comments Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Time Frame Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs)
Adverse Event Reporting Description All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.
 
Arm/Group Title 9- to 15-Year-Old Females (Lots 1, 2 or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Hide Arm/Group Description 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. 9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
All-Cause Mortality
9- to 15-Year-Old Females (Lots 1, 2 or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
9- to 15-Year-Old Females (Lots 1, 2 or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/1924 (0.83%)      11/662 (1.66%)      16/466 (3.43%)    
Gastrointestinal disorders       
Abdominal pain   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  3
Colitis   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Colitis ulcerative   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Gastritis   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
General disorders       
Pyrexia   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Hepatobiliary disorders       
Biliary colic   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Infections and infestations       
Acute tonsillitis   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Appendicitis   2/1924 (0.10%)  2 3/662 (0.45%)  3 0/466 (0.00%)  0
Gastroenteritis   0/1924 (0.00%)  0 1/662 (0.15%)  1 1/466 (0.21%)  1
Gastrointestinal infection   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Infectious mononucleosis   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Paronychia   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Pharyngotonsillitis   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Pneumonia   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Upper respiratory tract infection   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Urinary tract infection   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Injury, poisoning and procedural complications       
Ankle fracture   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Concussion   1/1924 (0.05%)  1 0/662 (0.00%)  0 1/466 (0.21%)  1
Foot fracture   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Gun shot wound   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Limb injury   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Tibia fracture   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Tongue injury   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Nervous system disorders       
Headache   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Hypoxic-ischaemic encephalopathy   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Cervical incompetence   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Ectopic pregnancy   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Foetal distress syndrome   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Psychiatric disorders       
Acute psychosis   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Suicidal ideation   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Reproductive system and breast disorders       
Ovarian cyst   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Asthmatic crisis   0/1924 (0.00%)  0 1/662 (0.15%)  1 0/466 (0.00%)  0
Oropharyngeal pain   1/1924 (0.05%)  1 0/662 (0.00%)  0 0/466 (0.00%)  0
Respiratory distress   0/1924 (0.00%)  0 0/662 (0.00%)  0 1/466 (0.21%)  1
Surgical and medical procedures       
Abortion induced   1/1924 (0.05%)  1 0/662 (0.00%)  0 5/466 (1.07%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
9- to 15-Year-Old Females (Lots 1, 2 or 3) 9- to 15-Year-Old Males (Lot 1) 16- to 26-Year-Old Females (Lot 1)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1624/1924 (84.41%)      506/662 (76.44%)      402/466 (86.27%)    
General disorders       
Injection site erythema   567/1924 (29.47%)  827 160/662 (24.17%)  220 132/466 (28.33%)  219
Injection site pain   1545/1924 (80.30%)  3530 465/662 (70.24%)  916 391/466 (83.91%)  964
Injection site swelling   668/1924 (34.72%)  1061 172/662 (25.98%)  247 151/466 (32.40%)  260
Pyrexia   197/1924 (10.24%)  232 85/662 (12.84%)  95 43/466 (9.23%)  53
Nervous system disorders       
Headache   352/1924 (18.30%)  505 98/662 (14.80%)  143 104/466 (22.32%)  164
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 study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943722     History of Changes
Other Study ID Numbers: V503-002
2009_611
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: December 12, 2014
Results First Posted: January 13, 2015
Last Update Posted: October 16, 2017