| Primary | Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| | | Title | Denominators | Categories |
|---|
| | |
| | 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 |
|---|
| | Miettinen & Nurminen | Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26 | <0.001 | Since p<0.05, the hypothesis of noninferiority is accepted for this outcome. | | | | | | 95 | | | | | | Yes | Non-Inferiority or Equivalence | The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5% | |
|
| Secondary | Acceptable Safety Profile | | | Not Posted | | | | | | 15 days post injection | | | | | | |
| Primary | Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months) | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months) | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactraâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactraâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactraâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactraâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Number | | Participants | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASILâ„¢ | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASILâ„¢ | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASILâ„¢ | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASILâ„¢ | | Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACELâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACELâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACELâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |
| Primary | Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACELâ„¢ | | Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data. | Posted | | Geometric Mean | 95% Confidence Interval | ELISA units/mL | | 7 Months | | | | ID | Title | Description |
|---|
| OG000 | Concomitant Administration | Concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ | | OG001 | Non-concomitant Administration | Non-concomitant administration of quadrivalent HPV vaccine and Menactraâ„¢ and ADACELâ„¢ |
| |