| Primary | Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG003 | Girls 9 to 14 Years V503 at Months 0, 2, and 6 | Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. | | OG004 | Young Women 16 to 26 Years V503 at Months 0, 2, and 6 | Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. |
| | Units | Counts |
|---|
| Participants | - OG000258
- OG001263
- OG002257
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001657.9(1479.6 to 1857.6)
- OG0011557.4(1391.5 to 1743.1)
- OG0022678.8(2390.2 to 3002.1)
- OG003
|
|
| | 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 |
|---|
| | ANOVA | One-sided non-inferiority test at alpha=0.025 level | <0.001 | | GMT ratio | 2.15 | | | 2-Sided | 95 | 1.83 | 2.53 | | | | | Non-Inferiority or Equivalence | Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67. | | |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Primary | Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Primary | Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 | |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Secondary | Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen | Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Other Pre-specified | Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 | Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
|
| Other Pre-specified | Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 | Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. |
|
| Other Pre-specified | Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 | Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL). | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 36 | | | | ID | Title | Description |
|---|
| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG002 | Girls and Boys 9 to 14 Years V503 at Months 0 and 12 |
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| Other Pre-specified | Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 | Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay. | All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Month 36 | | | | ID | Title | Description |
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| OG000 | Girls 9 to 14 Years V503 at Months 0 and 6 | Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. | | OG001 | Boys 9 to 14 Years V503 at Months 0 and 6 | Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. |
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