| Primary | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2 | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately. | Analysis was performed on hSBA Per-Protocol Analysis Set for meningococcal vaccines (PPASM) which was a subset that included all participants who received a dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPASM. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
| | | Title | Denominators | Categories |
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| Serogroup A | - ParticipantsOG000159
- ParticipantsOG001160
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| | 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 |
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| | | | | | Difference in Percentage | 4.98 | | | 2-Sided | 95 | 0.06 | 10.36 | | | | | Non-Inferiority | The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (>) -10%. | | |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | GMTs against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. | Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. | | OG002 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Percentage of participants With hSBA antibody titers >=1:4 and >=1:8 for serogroups A, C, Y, and W were reported in the outcome measure. | Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. | | OG002 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) |
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| Secondary | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Antibody titers against Meningococcal Serogroups A, C, Y and W were measured by hSBA. Fold-rise was calculated as ratio of post-dose titer on Day 31 to pre-dose titer on Day 01. | Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Baseline (Day 01) to Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. | | OG002 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | |
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| Secondary | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for participants with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8. | Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. | | OG002 |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2 | GMTs against meningococcal Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy < 2 years of age) were measured by hSBA. Titers were expressed in terms of 1/dilution. | Analysis was performed on participants who were MenC primed, received a dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded. Here, 'number analyzed' = participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2 | GMTs against Serogroup C in MenC primed participants (participants who received monovalent MenC priming in infancy < 2 years of age) were measured by rSBA. Titers were expressed in terms of 1/dilution. | Analysis was performed on participants who were MenC primed. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 | Geometric mean concentrations of anti-Diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis performed on Per-Protocol Analysis Set for concomitant vaccines (PPASC) which was a subset that included all participants who received a dose of study vaccine and had a valid post-vaccination serology result. Participants who presented protocol deviations and who did not produce a valid test result were excluded from PPASC. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | International units/milliliter (IU/mL) | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 | GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 | GMCs of anti-pertussis antibodies (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) and fimbriae types 2 and 3 [FIM], were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | Endotoxin units per milliliter (EU/mL) | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | GMCs of anti-diphtheria, and tetanus antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | GMCs of anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. Concentrations were expressed in terms of titers (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | GMCs of anti-pertussis antibodies (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 | Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 61 and Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Diphtheria, Tetanus, and Pertussis (PT, FHA, FIM, and PRN) antibodies were measured by electro chemiluminescent method. Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. GMCRs were calculated as the ratio of GMCs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine in Groups 1 and 2 | Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers >= 8 (1/dilution). Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Percentage of Participants With Antibody Titers Above Predefined Thresholds Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Antibody titers above predefined thresholds against Tdap-IPV vaccine antigens were defined as: Anti-D Ab titers and Anti-T Ab titers >= 0.1 IU/mL, and >= 1.0 IU/mL; Anti-Polio 1, 2, and 3 Ab titers >= 8 (1/dilution). Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Vaccine seroresponse was defined as post-vaccination concentration >= 4 * Baseline concentration, if the anti-pertussis antibody concentration at Baseline was < 4*lower limit of quantification (LLOQ), or >= 2*Baseline concentration, if the anti-pertussis antibody concentration at Baseline was >= 4*LLOQ. Post vaccine seroresponse for anti-pertussis antigens was Day 31 for Group 3 and Day 61 for Groups 1 and 2. | Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. | |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Titers were expressed in terms of 1/dilution. Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV antibodies were measured by the direct virus-like particle (VLP) electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 61/Day 31. Blood samples were assessed for participants at Day 31 and at Day 61, respectively. | Analysis was performed on PPASC. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 31 (post-vaccination) and Day 61 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV antibodies were measured by the direct VLP electrochemiluminescence multi-plex immunoassay for detection of antibodies towards HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GMTRs were calculated as the ratio of GMTs at Day 31/Day 01. Blood samples were assessed for participants at Day 01 and at Day 31, respectively. | Analysis was performed on PPASC. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | | | | ID | Title | Description |
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| OG000 | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
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| Secondary | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Vaccine Seroconversion was defined as changing serostatus from seronegative (participants with a titer inferior to the serostatus cut-off value) at Baseline to seropositive after vaccination. A participant with a titer at or above the serostatus cut-off for a given HPV type was considered seropositive for that type. The serostatus cut-offs for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were 9, 6, 5, 5, 3, 4, 3, 5 and 5 milli-Merck units (mMU)/mL, respectively. Post vaccine seroconversion for antigens contained in HPV vaccine was Day 31 for Group 3 and Day 61 for Groups 1 and 2. | Analysis was performed on PPASC. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Reported AEs for each arm were presented as pre-specified in the study protocol. | Analysis was performed on safety analysis set that included all participants who had received at least one dose of the study vaccines and had any safety data available. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed. | Posted | | Count of Participants | | Participants | | Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 |
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| Secondary | Number of Participants Reporting Solicited Injection Site Reactions | SR: expected AR (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF & considered as related to product. Injection site reactions: pain, erythema, & swelling. Here, "0" in number analyzed for MenACYW categories signifies no participant were evaluable as in Group (Gps.) 2 MenACYW vaccine was not administered; for Gps.1& 3: "0" in number analyzed for Nimenrix signifies no participant were evaluable as in Gps. 1 & 3 Nimenrix was not administered. At Vaccination (vacc.)1 (Gps.1 & 2): "0" in number analyzed for 9vHPV & Tadp-IPV signifies no participant were evaluable as these vaccines were not administered at vacc.1 (Day01). At Vacc. 2 (Gps.1, 2 & 3): "0" in number analyzed for MenACYW and Nimenrix signifies no participant were evaluable as these vaccines were not administered at vacc. 2 (Day 31); & for Gps. 3 "0" in number analyzed for 9vHPV and Tadp-IPV signifies no participant were evaluable as these vaccines were not administered. | Analysis was performed on safety analysis set. Here, 'Number analyzed'=participants with available data for specified category. The assessment of injection site reactions (pain, swelling and erythema) after the MenACYW Conjugate vaccines (MenQuadfi and Nimenrix) and 2 other adolescent vaccines allowed in the assessment of local reactogenicity and helped in identifying injection site reaction per vaccine received. Reported AEs for each arm were presented as pre-specified in the study protocol. | Posted | | Count of Participants | | Participants | | Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) |
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| Secondary | Number of Participants Reporting Solicited Systemic Reactions | A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol. | Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed. | Posted | | Count of Participants | | Participants | | Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. | Analysis was performed on safety analysis set. Here, 'Number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that at Day 31, participants of Group 3 received no vaccination and thus data were not collected and analyzed. | Posted | | Count of Participants | | Participants | | From Day 01 up to Day 31 post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) were defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Reported AEs for each arm were presented as pre-specified in the study protocol. | Analysis was performed on safety analysis set. | Posted | | Count of Participants | | Participants | | From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3) | | | | ID | Title | Description |
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| OG000 | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. | | OG001 | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Participants received 0.5 mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
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