A Study of V503 (A Multivalent Human Papillomavirus [HPV]... | NCT00943722 | Trialant
NCT00943722
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 3, 2022Actual
Enrollment
3,074Actual
Phase
Phase 3
Conditions
Cervical Cancers
Vulvar Cancer
Vaginal Cancer
Genital Lesions
PAP Test Abnormalities
HPV Infections
Interventions
V503
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00943722
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V503-002
Secondary IDs
ID
Type
Description
Link
2009_611
Other Identifier
Merck
2009-011617-25
EudraCT Number
Brief Title
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Official Title
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 27, 2009Actual
Primary Completion Date
Apr 30, 2011Actual
Completion Date
Apr 22, 2021Actual
First Submitted Date
Jul 21, 2009
First Submission Date that Met QC Criteria
Jul 21, 2009
First Posted Date
Jul 22, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2014
Results First Submitted that Met QC Criteria
Jan 12, 2015
Results First Posted Date
Jan 13, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 22, 2022
Last Update Posted Date
Oct 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.
The primary hypotheses are as follows:
The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.
9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.
The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
Detailed Description
The base study V503-002 was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.
An optional extension study (V503-002 EXT1) collected safety and immunogenicity information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study were not included in EXT1. Per protocol, EXT1 included immunogenicity data from a subset of 9- to 15-year-old females and safety data from all 9- to 15-year-old females regardless of lot administered.
An optional second extension study (V503-002 EXT2) collected long-term safety and immunogenicity information through approximately Month 126. No study vaccine was administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base study were not included in EXT2. Per protocol, EXT2 included immunogenicity data from a subset of 9- to 15-year-old females and effectiveness and safety data from all 9- to 15-year-old females regardless of lot administered.
Conditions Module
Conditions
Cervical Cancers
Vulvar Cancer
Vaginal Cancer
Genital Lesions
PAP Test Abnormalities
HPV Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
3,074Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
9- to 15-Year-Old Females (Lot 1)
Experimental
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 Lot 1.
Biological: V503
9- to 15-Year-Old Females (Lot 2)
Experimental
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 Lot 2.
Biological: V503
9- to 15-Year-Old Females (Lot 3)
Experimental
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 Lot 3.
Biological: V503
9- to 15-Year-Old Males (Lot 1)
Experimental
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 Lot 1.
Biological: V503
16- to 26-Year-Old Females (Lot 1)
Experimental
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 Lot 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
V503
Biological
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
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 were reported in milli Merck Units/mL.
4 weeks post-vaccination 3 (Month 7)
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
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 were reported in milli Merck Units/mL.
4 weeks post-vaccination 3 (Month 7)
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
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 were reported in milli Merck Units/mL.
4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
An AE was 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 was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Up to 5 days after any vaccination
Base Study: Percentage of Participants With Systemic AEs
Secondary Outcomes
Measure
Description
Time Frame
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Boys and Girls Age 9 to 15:
Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
Women Age 16 to 26:
Participant has never had Pap testing or has had only normal results
Participant has had 0 to 4 sexual partners at the time of enrollment
Exclusion Criteria:
Boys and Girls Age 9 to 15:
History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Participant is pregnant
Participant is immunocompromised or has taken immunosuppressants in the last year
Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
Participant has a history of positive test for HPV
Women Age 16 to 26:
History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Participant is pregnant
Participant is immunocompromised or has taken immunosuppressants in the last year
Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
Participant has a history of positive test for HPV
Participant has a history of abnormal cervical biopsy result
Participant has a history of external genital lesions
Luxembourg A, Moreira ED Jr, Samakoses R, Kim KH, Sun X, Maansson R, Moeller E, Christiano S, Chen J. Phase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine. Hum Vaccin Immunother. 2015;11(6):1306-12. doi: 10.1080/21645515.2015.1009819.
Extension study 1 (EXT1) collected data to Month 36. Extension study 2 (EXT2) collected long-term data through ~Month 126. No study vaccine was administered.
Per protocol, participants enrolled in the 16- to 26-year-old arm in the base study were not included in the extension study.
Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered (arm: "Extension Study: 9- to 15- Year Old Females").
Recruitment Details
The base study was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
FG001
Base Study: 9- to 15-Year-Old Females (Lot 2)
Periods
Title
Milestones
Reasons Not Completed
Base Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Sep 6, 2012
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Belgium
Brazil
Chile
Colombia
Costa Rica
Finland
India
Peru
Poland
South Africa
South Korea
Spain
Sweden
Taiwan
Thailand
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: V503
16- to 26-Year-Old Females (Lot 1)
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)
An AE was 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 was also an AE. Systemic AEs were those not categorized as injection-site AEs.
Up to 15 days after any vaccination
Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
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.
Up to 5 days after any vaccination
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Serum antibody titers (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Up to ~Month 126
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Up to ~Month 126
4 weeks post-vaccination 3 (Month 7)
Base Study: 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])
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.
4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
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.
4 weeks post-vaccination 3 (Month 7)
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females
Persistent infection is when a participant is positive by polymerase chain reaction (PCR) for the same HPV type in cervicovaginal/external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later. Per protocol, the extension study included 9- to 15-year-old females regardless of lot administered.
Up to ~Month 126
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males
Persistent infection is when a participant is positive by PCR for the same HPV type in external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later.
Up to ~Month 126
Extension Study: Combined Incidence of Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Genital Warts, and Cervical/Vulvar/Vaginal Cancers Related to HPV 6/11/16/18/31/33/45/52/58 in Females
The combined incidence of cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, and cervical/vulvar/vaginal cancers, related to HPV 6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Up to ~Month 126
Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males
The combined incidence of penile intraepithelial neoplasia, penile/perineal/perianal cancers, and genital warts related to HPV6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. For each study participant, person-years follow up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later.
Up to ~Month 126
Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events
A serious adverse event (SAE) included a death which resulted in the participant discontinuing the study, a serious adverse experience that was considered by an investigator who was a qualified physician to be possibly, probably, or definitely vaccine related or study procedure related. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Up to ~Month 126
Result
Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, Huang LM, Kim DS, Pitisuttithum P, Chen J, Christiano S, Maansson R, Moeller E, Sun X, Vuocolo S, Luxembourg A. Immunogenicity and Safety of a 9-Valent HPV Vaccine. Pediatrics. 2015 Jul;136(1):e28-39. doi: 10.1542/peds.2014-3745.
Olsson SE, Restrepo JA, Reina JC, Pitisuttithum P, Ulied A, Varman M, Van Damme P, Moreira ED Jr, Ferris D, Block S, Bautista O, Gallagher N, McCauley J, Luxembourg A. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. Papillomavirus Res. 2020 Dec;10:100203. doi: 10.1016/j.pvr.2020.100203. Epub 2020 Jul 11.
Restrepo J, Herrera T, Samakoses R, Reina JC, Pitisuttithum P, Ulied A, Bekker LG, Moreira ED, Olsson SE, Block SL, Hammes LS, Laginha F, Ferenczy A, Kurman R, Ronnett BM, Stoler M, Bautista O, Gallagher NE, Salituro G, Ye M, Luxembourg A. Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety. Pediatrics. 2023 Oct 1;152(4):e2022060993. doi: 10.1542/peds.2022-060993.
Garland SM, Pitisuttithum P, Ngan HYS, Cho CH, Lee CY, Chen CA, Yang YC, Chu TY, Twu NF, Samakoses R, Takeuchi Y, Cheung TH, Kim SC, Huang LM, Kim BG, Kim YT, Kim KH, Song YS, Lalwani S, Kang JH, Sakamoto M, Ryu HS, Bhatla N, Yoshikawa H, Ellison MC, Han SR, Moeller E, Murata S, Ritter M, Sawata M, Shields C, Walia A, Perez G, Luxembourg A. Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries. J Infect Dis. 2018 Jun 5;218(1):95-108. doi: 10.1093/infdis/jiy133.
Ruiz-Sternberg AM, Moreira ED Jr, Restrepo JA, Lazcano-Ponce E, Cabello R, Silva A, Andrade R, Revollo F, Uscanga S, Victoria A, Guevara AM, Luna J, Plata M, Dominguez CN, Fedrizzi E, Suarez E, Reina JC, Ellison MC, Moeller E, Ritter M, Shields C, Cashat M, Perez G, Luxembourg A. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Res. 2018 Jun;5:63-74. doi: 10.1016/j.pvr.2017.12.004. Epub 2017 Dec 19.
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
FG002
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
FG003
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
FG004
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
FG005
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
FG006
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
FG000648 subjects
FG001643 subjects
FG002644 subjects
FG003669 subjects
FG004470 subjects
FG0050 subjects
FG0060 subjects
Vaccination 1
FG000646 subjects
FG001642 subjects
FG002644 subjects
FG003666 subjects
FG004468 subjects
FG0050 subjects
FG0060 subjects
Vaccination 2
FG000637 subjects
FG001633 subjects
FG002638 subjects
FG003658 subjects
FG004462 subjects
FG0050 subjects
FG0060 subjects
Vaccination 3
FG000635 subjects
FG001627 subjects
FG002637 subjects
FG003653 subjects
FG004455 subjects
FG0050 subjects
FG0060 subjects
At Least One Dose With Protocol-specified Safety Follow-up
FG000643 subjects
FG001639 subjects
FG002641 subjects
FG003662 subjects
FG004466 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000623 subjects
FG001621 subjects
FG002631 subjects
FG003647 subjects
FG004444 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00025 subjects
FG00122 subjects
FG00213 subjects
FG00322 subjects
FG00426 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG00012 subjects
FG0018 subjects
FG00210 subjects
FG0038 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00012 subjects
FG00113 subjects
FG0022 subjects
FG00313 subjects
FG004
Month 12 visit not completed
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
First Extension Study: EXT 1
Type
Comment
Milestone Data
STARTED
The optional EXT1 included eligible participants from the base study, with the exception of 16-26 year old females.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051604 subjects
FG006568 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Second Extension Study: EXT 2
Type
Comment
Milestone Data
STARTED
The optional EXT2 included eligible participants from the base study, with the exception of 16-26 year old females.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005971 subjects
FG006301 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Per protocol, baseline characteristics were analyzed in all participants randomized in the base study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
BG001
Base Study: 9- to 15-Year-Old Females (Lot 2)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
BG002
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
BG003
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
BG004
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000648
BG001643
BG002644
BG003669
BG004470
BG0053074
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
9 to 12 years
Title
Measurements
BG000440
BG001432
BG002432
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000648
BG001643
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
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 were reported in milli Merck Units/mL.
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.
Posted
Geometric Mean
95% Confidence Interval
milli Merck Units/mL
4 weeks post-vaccination 3 (Month 7)
ID
Title
Description
OG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
OG001
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Units
Counts
Participants
OG000535
OG001378
Title
Denominators
Categories
Anti-HPV 6
ParticipantsOG000517
ParticipantsOG001328
Title
Measurements
OG0001715.4(1595.1 to 1844.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Anti-HPV 6
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
1.90
2-Sided
95
1.70
2.14
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Primary
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
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 were reported in milli Merck Units/mL.
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.
Posted
Geometric Mean
95% Confidence Interval
milli Merck Units/mL
4 weeks post-vaccination 3 (Month 7)
ID
Title
Description
OG000
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
OG001
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Primary
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
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 were reported in milli Merck Units/mL.
9-15-year-old females who received 3 vaccinations from Lots 1, 2, or 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.
Posted
Geometric Mean
95% Confidence Interval
milli Merck Units/mL
4 weeks post-vaccination 3 (Month 7)
ID
Title
Description
OG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
OG001
Base Study: 9- to 15-Year-Old Females (Lot 2)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
OG002
Base Study: 9- to 15-Year-Old Females (Lot 3)
Primary
Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
An AE was 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 was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
Posted
Number
Percentage of Participants
Up to 5 days after any vaccination
ID
Title
Description
OG000
9- to 15-Year-Old Females (Lots 1, 2 or 3)
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.
OG001
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
OG002
Base Study: 16- to 26-Year-Old Females (Lot 1)
Primary
Base Study: Percentage of Participants With Systemic AEs
An AE was 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 was also an AE. Systemic AEs were those not categorized as injection-site AEs.
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
Posted
Number
Percentage of Participants
Up to 15 days after any vaccination
ID
Title
Description
OG000
9- to 15-Year-Old Females (Lots 1, 2 or 3)
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.
OG001
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
OG002
Base Study: 16- to 26-Year-Old Females (Lot 1)
Primary
Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
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.
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
Posted
Number
Percentage of Participants
Up to 5 days after any vaccination
ID
Title
Description
OG000
9- to 15-Year-Old Females (Lots 1, 2, or 3)
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.
OG001
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
OG002
Base Study: 16- to 26-Year-Old Females (Lot 1)
Secondary
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
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.
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.
Posted
Number
95% Confidence Interval
Percentage of Participants
4 weeks post-vaccination 3 (Month 7)
ID
Title
Description
OG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
OG001
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Secondary
Base Study: 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])
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.
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
Posted
Number
95% Confidence Interval
Percentage of Participants
4 weeks post-vaccination 3 (Month 7)
ID
Title
Description
OG000
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
OG001
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Secondary
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
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.
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
Posted
Number
95% Confidence Interval
Percentage of Participants
4 weeks post-vaccination 3 (Month 7)
ID
Title
Description
OG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
OG001
Base Study: 9- to 15-Year-Old Females (Lot 2)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
Primary
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Serum antibody titers (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
All participants who met the 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.
Posted
Geometric Mean
95% Confidence Interval
milli Merck Units/mL
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
OG001
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
Primary
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
All participants who met the 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.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
OG001
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
Secondary
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females
Persistent infection is when a participant is positive by polymerase chain reaction (PCR) for the same HPV type in cervicovaginal/external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later. Per protocol, the extension study included 9- to 15-year-old females regardless of lot administered.
The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11 HPV11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
Posted
Number
95% Confidence Interval
Cases per 10,000 person-years
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
Secondary
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males
Persistent infection is when a participant is positive by PCR for the same HPV type in external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later.
The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
Posted
Number
95% Confidence Interval
Cases per 10,000 person-years
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
Units
Secondary
Extension Study: Combined Incidence of Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Genital Warts, and Cervical/Vulvar/Vaginal Cancers Related to HPV 6/11/16/18/31/33/45/52/58 in Females
The combined incidence of cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, and cervical/vulvar/vaginal cancers, related to HPV 6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
Posted
Number
95% Confidence Interval
Cases per 10,000 person-years
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
Secondary
Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males
The combined incidence of penile intraepithelial neoplasia, penile/perineal/perianal cancers, and genital warts related to HPV6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. For each study participant, person-years follow up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later.
The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
Posted
Number
95% Confidence Interval
Cases per 10,000 person-years
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
Secondary
Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events
A serious adverse event (SAE) included a death which resulted in the participant discontinuing the study, a serious adverse experience that was considered by an investigator who was a qualified physician to be possibly, probably, or definitely vaccine related or study procedure related. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
All participants who received at least 1 study vaccination in the base study and had follow-up data.
Posted
Number
Percentage of Participants
Up to ~Month 126
ID
Title
Description
OG000
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
OG001
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
Time Frame
Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Description
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Base Study: 9- to 15-Year-Old Females (Lot 1)
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 was obtained from manufacturing Lot 1.
0
648
6
643
538
643
EG001
Base Study: 9- to 15-Year-Old Females (Lot 2)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
0
643
2
639
537
639
EG002
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
0
644
8
641
554
641
EG003
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
0
669
11
662
505
662
EG004
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
0
470
15
466
404
466
EG005
EXT1: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
1
1,604
2
1,604
0
1,604
EG006
EXT1: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
0
568
0
568
0
568
EG007
EXT2: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
1
971
3
971
0
971
EG008
EXT2: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
0
301
0
301
0
301
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG0030 events0 affected662 at risk
EG0043 events1 affected466 at risk
EG0050 events0 affected1,604 at risk
EG0060 events0 affected568 at risk
EG0070 events0 affected971 at risk
EG0080 events0 affected301 at risk
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected643 at risk
EG0011 events1 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Tongue injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Brain injury
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Abortion threatened
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Cervical incompetence
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Acute psychosis
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0021 events1 affected641 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected643 at risk
EG0010 events0 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected643 at risk
EG0011 events1 affected639 at risk
EG0020 events0 affected641 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site erythema
General disorders
MedDRA 23.1
Systematic Assessment
EG000264 events184 affected643 at risk
EG001287 events192 affected639 at risk
EG002281 events195 affected641 at risk
EG003219 events159 affected662 at risk
EG004220 events132 affected466 at risk
EG0050 events0 affected1,604 at risk
EG0060 events0 affected568 at risk
EG0070 events0 affected971 at risk
EG0080 events0 affected301 at risk
Injection site pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0001,166 events506 affected643 at risk
EG0011,183 events513 affected639 at risk
EG0021,215 events529 affected641 at risk
EG003
Injection site swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG000317 events207 affected643 at risk
EG001372 events237 affected639 at risk
EG002380 events226 affected641 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG00091 events76 affected643 at risk
EG00167 events57 affected639 at risk
EG00274 events64 affected641 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG000182 events120 affected643 at risk
EG001170 events122 affected639 at risk
EG002156 events113 affected641 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D014845
Vulvar Diseases
D014623
Vaginal Diseases
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D003141
Communicable Diseases
D007239
Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D014412
Tumor Virus Infections
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
11 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
8 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0051489 subjects
FG006527 subjects
0 subjects
FG005115 subjects
FG00641 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00538 subjects
FG00610 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00532 subjects
FG00610 subjects
Disposition Unknown
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00544 subjects
FG00621 subjects
0 subjects
FG005720 subjects
FG006202 subjects
0 subjects
FG005251 subjects
FG00699 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005111 subjects
FG00646 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0063 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005137 subjects
FG00650 subjects
450
BG0040
BG0051754
13 to 15 years
Title
Measurements
BG000208
BG001211
BG002212
BG003219
BG0040
BG005850
16 to 26 years
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG004470
BG005470
644
BG0030
BG004470
BG0052405
Male
BG0000
BG0010
BG0020
BG003669
BG0040
BG005669
OG001900.8(822.3 to 986.9)
Anti-HPV 11
ParticipantsOG000517
ParticipantsOG001332
Title
Measurements
OG0001295.1(1204.1 to 1393.0)
OG001706.6(645.2 to 773.8)
Anti-HPV 16
ParticipantsOG000529
ParticipantsOG001329
Title
Measurements
OG0006979.8(6508.1 to 7485.8)
OG0013522.6(3223.5 to 3849.5)
Anti-HPV 18
ParticipantsOG000531
ParticipantsOG001345
Title
Measurements
OG0002153.7(1980.4 to 2342.1)
OG001882.7(795.4 to 979.5)
Anti-HPV 31
ParticipantsOG000522
ParticipantsOG001340
Title
Measurements
OG0001891.6(1745.7 to 2049.7)
OG001753.9(682.5 to 832.7)
Anti-HPV 33
ParticipantsOG000534
ParticipantsOG001354
Title
Measurements
OG000980.4(911.7 to 1054.3)
OG001466.8(426.9 to 510.3)
Anti-HPV 45
ParticipantsOG000534
ParticipantsOG001368
Title
Measurements
OG000714.4(651.9 to 782.8)
OG001272.2(243.8 to 303.9)
Anti-HPV 52
ParticipantsOG000533
ParticipantsOG001337
Title
Measurements
OG000932.9(864.8 to 1006.4)
OG001419.6(381.4 to 461.5)
Anti-HPV 58
ParticipantsOG000531
ParticipantsOG001332
Title
Measurements
OG0001286.7(1195.7 to 1384.6)
OG001590.5(538.2 to 647.9)
non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67.
OG000
OG001
Anti-HPV 11
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
1.83
2-Sided
95
1.63
2.06
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 16
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
1.98
2-Sided
95
1.77
2.22
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 18
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.44
2-Sided
95
2.13
2.80
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 31
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.51
2-Sided
95
2.21
2.85
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 33
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.10
2-Sided
95
1.87
2.36
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 45
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.62
2-Sided
95
2.27
3.03
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 52
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.22
2-Sided
95
1.97
2.51
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 58
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.18
2-Sided
95
1.93
2.45
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
Units
Counts
Participants
OG000570
OG001378
Title
Denominators
Categories
Anti-HPV 6
ParticipantsOG000559
ParticipantsOG001328
Title
Measurements
OG0002084.7(1944.0 to 2235.7)
OG001900.8(822.3 to 986.9)
Anti-HPV 11
ParticipantsOG000559
ParticipantsOG001332
Title
Measurements
OG0001487.1(1386.5 to 1595.0)
OG001
Anti-HPV 16
ParticipantsOG000569
ParticipantsOG001329
Title
Measurements
OG0008628.9(8065.9 to 9231.3)
OG001
Anti-HPV 18
ParticipantsOG000567
ParticipantsOG001345
Title
Measurements
OG0002822.8(2602.8 to 3061.5)
OG001
Anti-HPV 31
ParticipantsOG000564
ParticipantsOG001340
Title
Measurements
OG0002221.2(2056.1 to 2399.5)
OG001
Anti-HPV 33
ParticipantsOG000567
ParticipantsOG001354
Title
Measurements
OG0001198.7(1117.1 to 1286.2)
OG001
Anti-HPV 45
ParticipantsOG000570
ParticipantsOG001368
Title
Measurements
OG000907.0(830.2 to 991.0)
OG001
Anti-HPV 52
ParticipantsOG000568
ParticipantsOG001337
Title
Measurements
OG0001037.8(964.4 to 1116.9)
OG001
Anti-HPV 58
ParticipantsOG000566
ParticipantsOG001332
Title
Measurements
OG0001567.7(1460.2 to 1683.1)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Anti-HPV 6
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.31
2-Sided
95
2.07
2.59
GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 11
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.10
2-Sided
95
1.88
2.36
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 16
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.45
2-Sided
95
2.19
2.74
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 18
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
3.20
2-Sided
95
2.80
3.65
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 31
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.95
2-Sided
95
2.60
3.34
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 33
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.57
2-Sided
95
2.29
2.88
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 45
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
3.33
2-Sided
95
2.89
3.84
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 52
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.47
2-Sided
95
2.19
2.79
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
OG000
OG001
Anti-HPV 58
ANOVA
model with a response of log individual titers and a fixed effect for comparison group
< 0.001
one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group
GMT ratio
2.66
2-Sided
95
2.37
2.98
GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
Units
Counts
Participants
OG000535
OG001549
OG002565
Title
Denominators
Categories
Anti-HPV 6
ParticipantsOG000517
ParticipantsOG001536
ParticipantsOG002544
Title
Measurements
OG0001715.4(1588.7 to 1852.2)
OG0011763.3(1635.4 to 1901.3)
OG0021659.9(1540.3 to 1788.7)
Anti-HPV 11
ParticipantsOG000517
ParticipantsOG001536
ParticipantsOG002544
Title
Measurements
OG000
Anti-HPV 16
ParticipantsOG000529
ParticipantsOG001542
ParticipantsOG002556
Title
Measurements
OG000
Anti-HPV 18
ParticipantsOG000531
ParticipantsOG001547
ParticipantsOG002563
Title
Measurements
OG000
Anti-HPV 31
ParticipantsOG000522
ParticipantsOG001542
ParticipantsOG002553
Title
Measurements
OG000
Anti-HPV 33
ParticipantsOG000534
ParticipantsOG001543
ParticipantsOG002560
Title
Measurements
OG000
Anti-HPV 45
ParticipantsOG000534
ParticipantsOG001548
ParticipantsOG002565
Title
Measurements
OG000
Anti-HPV 52
ParticipantsOG000533
ParticipantsOG001547
ParticipantsOG002562
Title
Measurements
OG000
Anti-HPV 58
ParticipantsOG000531
ParticipantsOG001539
ParticipantsOG002560
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Anti-HPV 6
GMT ratio
0.97
2-Sided
95
0.88
1.08
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 6
GMT ratio
1.03
2-Sided
95
0.93
1.16
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
OG001
OG002
Anti-HPV 6
GMT ratio
1.06
2-Sided
95
0.95
1.19
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
OG000
OG001
Anti-HPV 11
GMT ratio
1.00
2-Sided
95
0.90
1.11
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
OG000
OG002
Anti-HPV 11
GMT ratio
1.07
2-Sided
95
0.95
1.20
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
OG001
OG002
Anti-HPV 11
GMT ratio
1.07
2-Sided
95
0.95
1.20
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
OG000
OG001
Anti-HPV 16
GMT ratio
0.96
2-Sided
95
0.86
1.06
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
OG000
OG002
Anti-HPV 16
GMT ratio
1.00
2-Sided
95
0.90
1.12
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 16
GMT ratio
1.05
2-Sided
95
0.94
1.17
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG001
Anti-HPV 18
GMT ratio
1.00
2-Sided
95
0.89
1.14
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 18
GMT ratio
1.11
2-Sided
95
0.98
1.26
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 18
GMT ratio
1.11
2-Sided
95
0.97
1.26
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG001
Anti-HPV 31
GMT ratio
1.00
2-Sided
95
0.89
1.13
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 31
GMT ratio
1.02
2-Sided
95
0.91
1.16
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 31
GMT ratio
1.02
2-Sided
95
0.90
1.15
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG001
Anti-HPV 33
GMT ratio
1.05
2-Sided
95
0.94
1.16
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 33
GMT ratio
1.05
2-Sided
95
0.94
1.17
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 33
GMT ratio
1.01
2-Sided
95
0.90
1.12
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG001
Anti-HPV 45
GMT ratio
0.84
2-Sided
95
0.73
0.95
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 45
GMT ratio
1.04
2-Sided
95
0.91
1.18
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 45
GMT ratio
1.24
2-Sided
95
1.08
1.42
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG001
Anti-HPV 52
GMT ratio
0.92
2-Sided
95
0.83
1.03
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 52
GMT ratio
0.95
2-Sided
95
0.85
1.07
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 52
GMT ratio
1.03
2-Sided
95
0.92
1.16
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG001
Anti-HPV 58
GMT ratio
0.95
2-Sided
95
0.86
1.06
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG000
OG002
Anti-HPV 58
GMT ratio
1.07
2-Sided
95
0.96
1.20
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
OG001
OG002
Anti-HPV 58
GMT ratio
1.12
2-Sided
95
1.00
1.26
GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Units
Counts
Participants
OG0001923
OG001662
OG002466
Title
Denominators
Categories
Title
Measurements
OG00081.9
OG00172.8
OG00285.4
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Units
Counts
Participants
OG0001923
OG001662
OG002466
Title
Denominators
Categories
Title
Measurements
OG00045.0
OG00141.8
OG00257.1
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
Units
Counts
Participants
OG0001908
OG001660
OG002463
Title
Denominators
Categories
Title
Measurements
OG0008.4
OG00110.0
OG0028.4
Units
Counts
Participants
OG000535
OG001378
Title
Denominators
Categories
Anti-HPV 6 cLIA ≥30 mMU/mL
ParticipantsOG000517
ParticipantsOG001328
Title
Measurements
OG00099.8(98.9 to 100)
OG00199.7(98.3 to 100)
Anti-HPV 11 cLIA ≥16 mMU/mL
ParticipantsOG000517
ParticipantsOG001332
Title
Measurements
OG000100(99.3 to 100.0)
OG001
Anti-HPV 16 cLIA ≥20 mMU/mL
ParticipantsOG000529
ParticipantsOG001329
Title
Measurements
OG000100(99.3 to 100.0)
OG001
Anti-HPV 18 cLIA ≥24 mMU/mL
ParticipantsOG000531
ParticipantsOG001345
Title
Measurements
OG00099.8(99.0 to 100.0)
OG001
Anti-HPV 31 cLIA ≥10 mMU/mL
ParticipantsOG000522
ParticipantsOG001340
Title
Measurements
OG000100.0(99.3 to 100.0)
OG001
Anti-HPV 33 cLIA ≥8 mMU/mL
ParticipantsOG000534
ParticipantsOG001354
Title
Measurements
OG000100.0(99.3 to 100.0)
OG001
Anti-HPV 45 cLIA ≥8 mMU/mL
ParticipantsOG000534
ParticipantsOG001368
Title
Measurements
OG00099.8(99.0 to 100.0)
OG001
Anti-HPV 52 cLIA ≥8 mMU/mL
ParticipantsOG000533
ParticipantsOG001337
Title
Measurements
OG000100.0(99.3 to 100.0)
OG001
Anti-HPV 58 cLIA ≥8 mMU/mL
ParticipantsOG000531
ParticipantsOG001332
Title
Measurements
OG000100.0(99.3 to 100.0)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Anti-HPV 6
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.1
2-Sided
95
-0.8
1.5
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 11
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.0
2-Sided
95
-0.7
1.2
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 16
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.0
2-Sided
95
-0.7
1.2
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 18
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.1
2-Sided
95
-0.8
1.5
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 31
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 33
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.6
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 45
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.4
2-Sided
95
-0.6
1.8
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 52
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 58
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.0
2-Sided
95
-0.7
1.2
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
Units
Counts
Participants
OG000570
OG001378
Title
Denominators
Categories
Anti-HPV 6 cLIA ≥30 mMU/mL
ParticipantsOG000559
ParticipantsOG001328
Title
Measurements
OG00099.8(99.0 to 100.0)
OG00199.7(98.3 to 100.0)
Anti-HPV 11 cLIA ≥16 mMU/mL
ParticipantsOG000559
ParticipantsOG001332
Title
Measurements
OG000100.0(99.3 to 100.0)
OG001
Anti-HPV 16 cLIA ≥20 mMU/mL
ParticipantsOG000569
ParticipantsOG001329
Title
Measurements
OG000100.0(99.4 to 100.0)
OG001
Anti-HPV 18 cLIA ≥24 mMU/mL
ParticipantsOG000567
ParticipantsOG001345
Title
Measurements
OG000100.0(99.4 to 100.0)
OG001
Anti-HPV 31 cLIA ≥10 mMU/mL
ParticipantsOG000564
ParticipantsOG001340
Title
Measurements
OG000100.0(99.3 to 100.0)
OG001
Anti-HPV 33 cLIA ≥8 mMU/mL
ParticipantsOG000567
ParticipantsOG001354
Title
Measurements
OG000100.0(99.4 to 100.0)
OG001
Anti-HPV 45 cLIA ≥8 mMU/mL
ParticipantsOG000570
ParticipantsOG001368
Title
Measurements
OG000100.0(99.4 to 100.0)
OG001
Anti-HPV 52 cLIA ≥8 mMU/mL
ParticipantsOG000568
ParticipantsOG001337
Title
Measurements
OG000100.0(99.4 to 100.0)
OG001
Anti-HPV 58 cLIA ≥8 mMU/mL
ParticipantsOG000566
ParticipantsOG001332
Title
Measurements
OG000100.0(99.4 to 100.0)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Anti-HPV 6
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.1
2-Sided
95
-0.7
1.5
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 11
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.0
2-Sided
95
-0.7
1.2
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 16
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.0
2-Sided
95
-0.7
1.2
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 18
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.6
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 31
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.7
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 33
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.6
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 45
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.5
2-Sided
95
-0.1
2.0
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 52
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.7
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG000
OG001
Anti-HPV 58
Miettinen and Nurminen
< 0.001
Percentage Point Difference
0.0
2-Sided
95
-0.7
1.2
Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
Non-Inferiority
Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
OG002
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
Units
Counts
Participants
OG000535
OG001549
OG002565
Title
Denominators
Categories
HPV 6 cLIA ≥30 mMU/mL
ParticipantsOG000517
ParticipantsOG001536
ParticipantsOG002544
Title
Measurements
OG00099.8(98.9 to 100.0)
OG00199.8(99.0 to 100.0)
OG00299.3(98.1 to 99.8)
HPV 11 cLIA ≥16 mMU/mL
ParticipantsOG000517
ParticipantsOG001536
ParticipantsOG002544
Title
Measurements
OG000
HPV 16 cLIA ≥20 mMU/mL
ParticipantsOG000529
ParticipantsOG001542
ParticipantsOG002556
Title
Measurements
OG000
HPV 18 cLIA ≥24 mMU/mL
ParticipantsOG000531
ParticipantsOG001547
ParticipantsOG002563
Title
Measurements
OG000
HPV 31 cLIA ≥10 mMU/mL
ParticipantsOG000522
ParticipantsOG001542
ParticipantsOG002553
Title
Measurements
OG000
HPV 33 cLIA ≥8 mMU/mL
ParticipantsOG000534
ParticipantsOG001543
ParticipantsOG002560
Title
Measurements
OG000
HPV 45 cLIA ≥8 mMU/mL
ParticipantsOG000534
ParticipantsOG001548
ParticipantsOG002565
Title
Measurements
OG000
HPV 52 cLIA ≥8 mMU/mL
ParticipantsOG000533
ParticipantsOG001547
ParticipantsOG002562
Title
Measurements
OG000
HPV 58 cLIA ≥8 mMU/mL
ParticipantsOG000531
ParticipantsOG001539
ParticipantsOG002560
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Anti-HPV 6
Percentage Point Difference
0.0
2-Sided
95
-0.9
0.9
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 6
Percentage Point Difference
0.5
2-Sided
95
-0.4
1.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 6
Percentage Point Difference
0.6
2-Sided
95
-0.4
1.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 11
Percentage Point Difference
0.0
2-Sided
95
-0.7
0.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 11
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 11
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 16
Percentage Point Difference
0.0
2-Sided
95
-0.7
0.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 16
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 16
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 18
Percentage Point Difference
-0.2
2-Sided
95
-1.1
0.5
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 18
Percentage Point Difference
0.2
2-Sided
95
-0.7
1.1
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 18
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 31
Percentage Point Difference
0.0
2-Sided
95
-0.7
0.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 31
Percentage Point Difference
0.2
2-Sided
95
-0.6
1.0
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 31
Percentage Point Difference
0.2
2-Sided
95
-0.5
1.0
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 33
Percentage Point Difference
0.0
2-Sided
95
-0.7
0.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 33
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 33
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 45
Percentage Point Difference
-0.2
2-Sided
95
-1.1
0.5
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 45
Percentage Point Difference
0.2
2-Sided
95
-0.7
1.1
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 45
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 52
Percentage Point Difference
0.0
2-Sided
95
-0.7
0.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 52
Percentage Point Difference
0.3
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 52
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG001
Anti-HPV 58
Percentage Point Difference
0.0
2-Sided
95
-0.7
0.7
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG000
OG002
Anti-HPV 58
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
OG001
OG002
Anti-HPV 58
Percentage Point Difference
0.4
2-Sided
95
-0.4
1.3
Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
Equivalence
equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).