Cervical Cancers, Genital Lesions, HPV Infections, PAP Test Abnormalities, Vaginal Cancer, Vulvar Cancer
Conditions
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: 1. 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. 2. 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. 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. 4. 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.
Interventions
BIOLOGICALV503
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Up to ~Month 126 | 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. |
| 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]) | 4 weeks post-vaccination 3 (Month 7) | 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. |
| 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]) | 4 weeks post-vaccination 3 (Month 7) | 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. |
| Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | 4 weeks post-vaccination 3 (Month 7) | 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. |
| Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) | Up to 5 days after any vaccination | 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. |
| Base Study: Percentage of Participants With Systemic AEs | Up to 15 days after any vaccination | 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. |
| Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) | Up to 5 days after any vaccination | 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. |
| Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Up to ~Month 126 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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]) | 4 weeks post-vaccination 3 (Month 7) | 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. |
| 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]) | 4 weeks post-vaccination 3 (Month 7) | 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. |
| Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | 4 weeks post-vaccination 3 (Month 7) | 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. |
| Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females | Up to ~Month 126 | 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. |
| Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males | Up to ~Month 126 | 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. |
| 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 | Up to ~Month 126 | 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. |
| 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 | Up to ~Month 126 | 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. |
| Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events | Up to ~Month 126 | 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. |
Participant flow
Recruitment details
The base study was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 648 |
| 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. | 643 |
| 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. | 644 |
| 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. | 669 |
| 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. | 470 |
| Total | 3,074 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Base Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Base Study | Lost to Follow-up | 12 | 8 | 10 | 8 | 11 | 0 | 0 |
| Base Study | Month 12 visit not completed | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Base Study | Physician Decision | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Base Study | Pregnancy | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
| Base Study | Protocol Violation | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
| Base Study | Withdrawal by Subject | 12 | 13 | 2 | 13 | 8 | 0 | 0 |
| First Extension Study: EXT 1 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| First Extension Study: EXT 1 | Disposition Unknown | 0 | 0 | 0 | 0 | 0 | 44 | 21 |
| First Extension Study: EXT 1 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 38 | 10 |
| First Extension Study: EXT 1 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 32 | 10 |
| Second Extension Study: EXT 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Second Extension Study: EXT 2 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 111 | 46 |
| Second Extension Study: EXT 2 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 3 |
| Second Extension Study: EXT 2 | Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Second Extension Study: EXT 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 137 | 50 |
Baseline characteristics
| Characteristic | Total | Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: 9- to 15-Year-Old Females (Lot 2) | Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: 16- to 26-Year-Old Females (Lot 1) |
|---|---|---|---|---|---|---|
| Age, Customized 13 to 15 years | 850 Participants | 208 Participants | 211 Participants | 212 Participants | 219 Participants | 0 Participants |
| Age, Customized 16 to 26 years | 470 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 470 Participants |
| Age, Customized 9 to 12 years | 1754 Participants | 440 Participants | 432 Participants | 432 Participants | 450 Participants | 0 Participants |
| Sex: Female, Male Female | 2405 Participants | 648 Participants | 643 Participants | 644 Participants | 0 Participants | 470 Participants |
| Sex: Female, Male Male | 669 Participants | 0 Participants | 0 Participants | 0 Participants | 669 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 648 | 0 / 643 | 0 / 644 | 0 / 669 | 0 / 470 | 1 / 1,604 | 0 / 568 | 1 / 971 | 0 / 301 |
| other Total, other adverse events | 538 / 643 | 537 / 639 | 554 / 641 | 505 / 662 | 404 / 466 | 0 / 1,604 | 0 / 568 | 0 / 971 | 0 / 301 |
| serious Total, serious adverse events | 6 / 643 | 2 / 639 | 8 / 641 | 11 / 662 | 15 / 466 | 2 / 1,604 | 0 / 568 | 3 / 971 | 0 / 301 |
Outcome results
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.
Time frame: 4 weeks post-vaccination 3 (Month 7)
Population: 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 31 | 1891.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 16 | 6979.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 33 | 980.4 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 11 | 1295.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 45 | 714.4 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 18 | 2153.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 52 | 932.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 58 | 1286.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 6 | 1715.4 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 58 | 590.5 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 6 | 900.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 11 | 706.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 16 | 3522.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 18 | 882.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 31 | 753.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 33 | 466.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 45 | 272.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 52 | 419.6 milli Merck Units/mL |
Comparison: Anti-HPV 6p-value: <0.00195% CI: [1.7, 2.14]ANOVA
Comparison: Anti-HPV 11p-value: <0.00195% CI: [1.63, 2.06]ANOVA
Comparison: Anti-HPV 16p-value: <0.00195% CI: [1.77, 2.22]ANOVA
Comparison: Anti-HPV 45p-value: <0.00195% CI: [2.27, 3.03]ANOVA
Comparison: Anti-HPV 18p-value: <0.00195% CI: [2.13, 2.8]ANOVA
Comparison: Anti-HPV 31p-value: <0.00195% CI: [2.21, 2.85]ANOVA
Comparison: Anti-HPV 33p-value: <0.00195% CI: [1.87, 2.36]ANOVA
Comparison: Anti-HPV 52p-value: <0.00195% CI: [1.97, 2.51]ANOVA
Comparison: Anti-HPV 58p-value: <0.00195% CI: [1.93, 2.45]ANOVA
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.
Time frame: 4 weeks post-vaccination 3 (Month 7)
Population: 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 33 | 1198.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 6 | 2084.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 11 | 1487.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 16 | 8628.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 18 | 2822.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 31 | 2221.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 45 | 907.0 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 52 | 1037.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 58 | 1567.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 58 | 590.5 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 31 | 753.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 6 | 900.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 33 | 466.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 11 | 706.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 52 | 419.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 16 | 3522.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 45 | 272.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 18 | 882.7 milli Merck Units/mL |
Comparison: Anti-HPV 6p-value: <0.00195% CI: [2.07, 2.59]ANOVA
Comparison: Anti-HPV 11p-value: <0.00195% CI: [1.88, 2.36]ANOVA
Comparison: Anti-HPV 16p-value: <0.00195% CI: [2.19, 2.74]ANOVA
Comparison: Anti-HPV 18p-value: <0.00195% CI: [2.8, 3.65]ANOVA
Comparison: Anti-HPV 31p-value: <0.00195% CI: [2.6, 3.34]ANOVA
Comparison: Anti-HPV 33p-value: <0.00195% CI: [2.29, 2.88]ANOVA
Comparison: Anti-HPV 45p-value: <0.00195% CI: [2.89, 3.84]ANOVA
Comparison: Anti-HPV 52p-value: <0.00195% CI: [2.19, 2.79]ANOVA
Comparison: Anti-HPV 58p-value: <0.00195% CI: [2.37, 2.98]ANOVA
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.
Time frame: 4 weeks post-vaccination 3 (Month 7)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 58 | 1286.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 6 | 1715.4 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 11 | 1295.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 16 | 6979.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 18 | 2153.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 31 | 1891.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 33 | 980.4 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 45 | 714.4 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 52 | 932.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 31 | 1867.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 58 | 1344.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 6 | 1763.3 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 18 | 2134.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 45 | 827.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 11 | 1311.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 52 | 1007.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 33 | 922.7 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 16 | 7292.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 33 | 931.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 58 | 1208.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 18 | 1966.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 31 | 1879.0 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 52 | 971.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 16 | 6948.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 6 | 1659.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 11 | 1232.0 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | Anti-HPV 45 | 678.4 milli Merck Units/mL |
Comparison: Anti-HPV 695% CI: [0.88, 1.08]
Comparison: Anti-HPV 695% CI: [0.93, 1.16]
Comparison: Anti-HPV 695% CI: [0.95, 1.19]
Comparison: Anti-HPV 1195% CI: [0.9, 1.11]
Comparison: Anti-HPV 1195% CI: [0.95, 1.2]
Comparison: Anti-HPV 1195% CI: [0.95, 1.2]
Comparison: Anti-HPV 1695% CI: [0.86, 1.06]
Comparison: Anti-HPV 1695% CI: [0.9, 1.12]
Comparison: Anti-HPV 1695% CI: [0.94, 1.17]
Comparison: Anti-HPV 1895% CI: [0.89, 1.14]
Comparison: Anti-HPV 1895% CI: [0.98, 1.26]
Comparison: Anti-HPV 1895% CI: [0.97, 1.26]
Comparison: Anti-HPV 3195% CI: [0.89, 1.13]
Comparison: Anti-HPV 3195% CI: [0.91, 1.16]
Comparison: Anti-HPV 3195% CI: [0.9, 1.15]
Comparison: Anti-HPV 3395% CI: [0.94, 1.16]
Comparison: Anti-HPV 3395% CI: [0.94, 1.17]
Comparison: Anti-HPV 3395% CI: [0.9, 1.12]
Comparison: Anti-HPV 4595% CI: [0.73, 0.95]
Comparison: Anti-HPV 4595% CI: [0.91, 1.18]
Comparison: Anti-HPV 4595% CI: [1.08, 1.42]
Comparison: Anti-HPV 5295% CI: [0.83, 1.03]
Comparison: Anti-HPV 5295% CI: [0.85, 1.07]
Comparison: Anti-HPV 5295% CI: [0.92, 1.16]
Comparison: Anti-HPV 5895% CI: [0.86, 1.06]
Comparison: Anti-HPV 5895% CI: [0.96, 1.2]
Comparison: Anti-HPV 5895% CI: [1, 1.26]
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.
Time frame: Up to 5 days after any vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) | 8.4 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) | 10.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) | 8.4 Percentage of Participants |
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.
Time frame: Up to 5 days after any vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) | 81.9 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) | 72.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) | 85.4 Percentage of Participants |
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.
Time frame: Up to 15 days after any vaccination
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants With Systemic AEs | 45.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants With Systemic AEs | 41.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants With Systemic AEs | 57.1 Percentage of Participants |
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.
Time frame: Up to ~Month 126
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 33 | 59.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 6 | 122.3 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 11 | 80.2 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 16 | 403.0 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 18 | 128.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 31 | 108.9 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 45 | 42.1 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 52 | 55.3 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 58 | 76.5 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 58 | 90.5 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 31 | 128.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 6 | 129.5 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 33 | 69.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 11 | 91.0 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 52 | 59.6 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 16 | 414.3 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 45 | 49.8 milli Merck Units/mL |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine | Anti-HPV 18 | 148.4 milli Merck Units/mL |
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.
Time frame: Up to ~Month 126
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 11 | 85.2 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 33 | 85.2 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 18 | 80.1 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 45 | 81.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 6 | 82.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 52 | 88.2 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 31 | 90.1 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 58 | 96.5 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 16 | 97.3 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 58 | 97.1 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 6 | 84.1 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 11 | 87.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 16 | 98.3 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 18 | 83.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 31 | 92.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 33 | 89.3 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 45 | 92.3 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine | Anti-HPV 52 | 89.2 Percentage of Participants |
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.
Time frame: 4 weeks post-vaccination 3 (Month 7)
Population: 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 11 cLIA ≥16 mMU/mL | 100 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 33 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 18 cLIA ≥24 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 45 cLIA ≥8 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 16 cLIA ≥20 mMU/mL | 100 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 52 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 31 cLIA ≥10 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 58 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 6 cLIA ≥30 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 58 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 6 cLIA ≥30 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 11 cLIA ≥16 mMU/mL | 100 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 16 cLIA ≥20 mMU/mL | 100 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 18 cLIA ≥24 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 31 cLIA ≥10 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 33 cLIA ≥8 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 45 cLIA ≥8 mMU/mL | 99.5 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 52 cLIA ≥8 mMU/mL | 99.7 Percentage of Participants |
Comparison: Anti-HPV 6p-value: <0.00195% CI: [-0.8, 1.5]Miettinen and Nurminen
Comparison: Anti-HPV 11p-value: <0.00195% CI: [-0.7, 1.2]Miettinen and Nurminen
Comparison: Anti-HPV 16p-value: <0.00195% CI: [-0.7, 1.2]Miettinen and Nurminen
Comparison: Anti-HPV 18p-value: <0.00195% CI: [-0.8, 1.5]Miettinen and Nurminen
Comparison: Anti-HPV 31p-value: <0.00195% CI: [-0.4, 1.7]Miettinen and Nurminen
Comparison: Anti-HPV 33p-value: <0.00195% CI: [-0.4, 1.6]Miettinen and Nurminen
Comparison: Anti-HPV 45p-value: <0.00195% CI: [-0.6, 1.8]Miettinen and Nurminen
Comparison: Anti-HPV 52p-value: <0.00195% CI: [-0.4, 1.7]Miettinen and Nurminen
Comparison: Anti-HPV 58p-value: <0.00195% CI: [-0.7, 1.2]Miettinen and Nurminen
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.
Time frame: 4 weeks post-vaccination 3 (Month 7)
Population: 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 11 cLIA ≥16 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 33 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 18 cLIA ≥24 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 45 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 16 cLIA ≥20 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 52 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 31 cLIA ≥10 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 58 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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]) | Anti-HPV 6 cLIA ≥30 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 58 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 6 cLIA ≥30 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 11 cLIA ≥16 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 16 cLIA ≥20 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 18 cLIA ≥24 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 31 cLIA ≥10 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 33 cLIA ≥8 mMU/mL | 99.7 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 45 cLIA ≥8 mMU/mL | 99.5 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | 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]) | Anti-HPV 52 cLIA ≥8 mMU/mL | 99.7 Percentage of Participants |
Comparison: Anti-HPV 6p-value: <0.00195% CI: [-0.7, 1.5]Miettinen and Nurminen
Comparison: Anti-HPV 11p-value: <0.00195% CI: [-0.7, 1.2]Miettinen and Nurminen
Comparison: Anti-HPV 16p-value: <0.00195% CI: [-0.7, 1.2]Miettinen and Nurminen
Comparison: Anti-HPV 18p-value: <0.00195% CI: [-0.4, 1.6]Miettinen and Nurminen
Comparison: Anti-HPV 31p-value: <0.00195% CI: [-0.4, 1.7]Miettinen and Nurminen
Comparison: Anti-HPV 33p-value: <0.00195% CI: [-0.4, 1.6]Miettinen and Nurminen
Comparison: Anti-HPV 45p-value: <0.00195% CI: [-0.1, 2]Miettinen and Nurminen
Comparison: Anti-HPV 52p-value: <0.00195% CI: [-0.4, 1.7]Miettinen and Nurminen
Comparison: Anti-HPV 58p-value: <0.00195% CI: [-0.7, 1.2]Miettinen and Nurminen
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.
Time frame: 4 weeks post-vaccination 3 (Month 7)
Population: 9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 33 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 6 cLIA ≥30 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 11 cLIA ≥16 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 16 cLIA ≥20 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 18 cLIA ≥24 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 31 cLIA ≥10 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 45 cLIA ≥8 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 52 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 58 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 31 cLIA ≥10 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 45 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 6 cLIA ≥30 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 52 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 33 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 11 cLIA ≥16 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 18 cLIA ≥24 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 58 cLIA ≥8 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 16 cLIA ≥20 mMU/mL | 100.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 58 cLIA ≥8 mMU/mL | 99.6 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 18 cLIA ≥24 mMU/mL | 99.6 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 52 cLIA ≥8 mMU/mL | 99.6 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 31 cLIA ≥10 mMU/mL | 99.8 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 33 cLIA ≥8 mMU/mL | 99.6 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 16 cLIA ≥20 mMU/mL | 99.6 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 6 cLIA ≥30 mMU/mL | 99.3 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 45 cLIA ≥8 mMU/mL | 99.6 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Females (Lot 3) | Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) | HPV 11 cLIA ≥16 mMU/mL | 99.6 Percentage of Participants |
Comparison: Anti-HPV 695% CI: [-0.9, 0.9]
Comparison: Anti-HPV 695% CI: [-0.4, 1.7]
Comparison: Anti-HPV 695% CI: [-0.4, 1.7]
Comparison: Anti-HPV 1195% CI: [-0.7, 0.7]
Comparison: Anti-HPV 1195% CI: [-0.4, 1.3]
Comparison: Anti-HPV 1195% CI: [-0.4, 1.3]
Comparison: Anti-HPV 1695% CI: [-0.7, 0.7]
Comparison: Anti-HPV 1695% CI: [-0.4, 1.3]
Comparison: Anti-HPV 1695% CI: [-0.4, 1.3]
Comparison: Anti-HPV 1895% CI: [-1.1, 0.5]
Comparison: Anti-HPV 1895% CI: [-0.7, 1.1]
Comparison: Anti-HPV 1895% CI: [-0.4, 1.3]
Comparison: Anti-HPV 3195% CI: [-0.7, 0.7]
Comparison: Anti-HPV 3195% CI: [-0.6, 1]
Comparison: Anti-HPV 3195% CI: [-0.5, 1]
Comparison: Anti-HPV 3395% CI: [-0.7, 0.7]
Comparison: Anti-HPV 3395% CI: [-0.4, 1.3]
Comparison: Anti-HPV 3395% CI: [-0.4, 1.3]
Comparison: Anti-HPV 4595% CI: [-1.1, 0.5]
Comparison: Anti-HPV 4595% CI: [-0.7, 1.1]
Comparison: Anti-HPV 4595% CI: [-0.4, 1.3]
Comparison: Anti-HPV 5295% CI: [-0.7, 0.7]
Comparison: Anti-HPV 5295% CI: [-0.4, 1.3]
Comparison: Anti-HPV 5295% CI: [-0.4, 1.3]
Comparison: Anti-HPV 5895% CI: [-0.7, 0.7]
Comparison: Anti-HPV 5895% CI: [-0.4, 1.3]
Comparison: Anti-HPV 5895% CI: [-0.4, 1.3]
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.
Time frame: Up to ~Month 126
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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 | 2.2 Cases per 10,000 person-years | 95% Confidence Interval 0.1 |
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.
Time frame: Up to ~Month 126
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females | 52.4 Cases per 10,000 person-years | 95% Confidence Interval 33.6 |
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.
Time frame: Up to ~Month 126
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males | 54.6 Cases per 10,000 person-years | 95% Confidence Interval 21.9 |
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.
Time frame: Up to ~Month 126
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | 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 | 0.0 Cases per 10,000 person-years | 95% Confidence Interval 0 |
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.
Time frame: Up to ~Month 126
Population: All participants who received at least 1 study vaccination in the base study and had follow-up data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Study: 9- to 15-Year-Old Females (Lot 1) | Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events | 0.0 Percentage of Participants |
| Base Study: 9- to 15-Year-Old Males (Lot 1) | Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events | 0.0 Percentage of Participants |