Meningococcal Immunisation, Healthy Volunteers
Conditions
Brief summary
Primary Objective: To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2). Secondary Objective: To describe: * the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine \[adsorbed, reduced antigen(s) content\] (Tdap-IPV) vaccines (Group 3). * the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status. * the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination. * the safety profile in each group after each and any vaccination.
Detailed description
The duration of study participation for each participant was approximately 30 to 60 days, including 2 or 3 visits (1 or 2 vaccination visit) and 1 or 2 telephone calls, depending on study Group. \* This was the first dose of 9vHPV, of the 2-dose or 3-dose series according to the local recommendations and age of the participant. These additional vaccinations for the completion of 9vHPV schedule took place outside of the objectives and scope of this study and thus were not described in this protocol.
Interventions
Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
BIOLOGICALHuman Papillomavirus 9-valent Vaccine (9vHPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was performed in a partially observer-blind fashion: In Groups 1 and 2 * Investigators and study staff who conducted the safety assessment, participants, parents/legally acceptable representatives, the Sponsor, and laboratory personnel performing the serology testing were kept blinded to the vaccine received. * Only the study staff who prepared and administered the vaccine and were not involved with the safety evaluation know which vaccine was administered. In Group 3 \- Everyone involved in the study (i.e., Investigator, study staff, the Sponsor, participants, parents/legally acceptable representatives) know which vaccine was administered. This open-label design for Group 3 was due to the different vaccination schedule for this group than for Groups 1 and 2.
Intervention model description
This was a parallel group prevention study with 2 groups that were observer blind (only the person administering the vaccine was unblinded), and 1 group that was open-label.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of the 10th birthday to the day before the 18th birthday). * Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infancy (less than \[\<\] 2 years of age). * Assent form had been signed and dated by the participant as per local regulation, and Informed Consent Form had been signed and dated by the parent/legally acceptable representative and by the participant if she/he turns 18 years old during the study. * Participants and parent/legally acceptable representative were able to attend all scheduled visits and compiled with all study procedures. * Covered by health insurance, if required by local regulations.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche. * Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age. * Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which might receive at least 2 weeks before study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. * History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years. * Previous human papilloma virus (HPV) vaccination. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. * Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination. * Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy. * Verbal report of thrombocytopenia, contraindicating intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[\>= 100.4 degree Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Participant at high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 31 (post-vaccination) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | From Baseline (Day 01) to Day 31 (post-vaccination) | 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. |
| Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Day 31 (post-vaccination) | 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. |
| 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 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| 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 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| 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 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
| 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 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
| 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 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
| Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| 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 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
| Geometric Mean Concentrations Ratios (GMCRs) of Antibodies Against Antigens Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | GMTs against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| 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 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3) | 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. |
| Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
| Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
| Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Day 01 (pre-vaccination) and Day 31 (post-vaccination) | 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. |
| Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3) | 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. |
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | 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. |
| Number of Participants Reporting Solicited Injection Site Reactions | Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | 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. |
| Number of Participants Reporting Solicited Systemic Reactions | Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31]) | 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. |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | 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]) | 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. |
| Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3) | 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. |
| 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 | Day 31 (post-vaccination) and Day 61 (post-vaccination) | 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. |
Countries
Hungary, Italy, Singapore, Spain
Participant flow
Recruitment details
The study was conducted at 21 active centers in Hungary, Italy, Spain and Singapore between 16 March 2021 to 11 May 2022.
Pre-assignment details
A total of 463 participants were enrolled and randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 173 |
| 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. | 173 |
| 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. | 117 |
| Total | 463 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 1 |
| Overall Study | Withdrawal by parent/guardian | 2 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Total |
|---|---|---|---|---|
| Age, Continuous | 12.4 years STANDARD_DEVIATION 2.32 | 12.8 years STANDARD_DEVIATION 2.38 | 12.5 years STANDARD_DEVIATION 2.47 | 12.6 years STANDARD_DEVIATION 2.38 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 165 Participants | 169 Participants | 115 Participants | 449 Participants |
| Sex: Female, Male Female | 49 Participants | 57 Participants | 45 Participants | 151 Participants |
| Sex: Female, Male Male | 124 Participants | 116 Participants | 72 Participants | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 171 | 0 / 171 | 0 / 116 |
| other Total, other adverse events | 153 / 171 | 151 / 171 | 112 / 116 |
| serious Total, serious adverse events | 0 / 171 | 1 / 171 | 0 / 116 |
Outcome results
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.
Time frame: Day 31 (post-vaccination)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup A | 97.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup C | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup W | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup Y | 99.4 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup Y | 98.1 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup A | 92.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup W | 98.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Serogroup C | 95.0 percentage of participants |
Comparison: Serogroup A95% CI: [0.06, 10.36]
Comparison: Serogroup C95% CI: [1.58, 9.5]
Comparison: Serogroup W95% CI: [-1.28, 4.42]
Comparison: Serogroup Y95% CI: [-1.88, 4.77]
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Tetanus: Day 01 | 0.708 IU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Tetanus: Day 31 | 34.5 IU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Diphtheria: Day 01 | 0.256 IU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Diphtheria, Tetanus Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Diphtheria: Day 31 | 2.91 IU/mL |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Tetanus: Day 31 | 25.5 International units/milliliter (IU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Diphteria: Day 31 | 0.200 International units/milliliter (IU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Tetanus: Day 61 | 17.3 International units/milliliter (IU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Diphteria: Day 61 | 3.75 International units/milliliter (IU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Diphteria: Day 61 | 3.88 International units/milliliter (IU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Tetanus: Day 31 | 18.4 International units/milliliter (IU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Tetanus: Day 61 | 16.1 International units/milliliter (IU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Diphteria: Day 31 | 0.215 International units/milliliter (IU/mL) |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-PT: Day 01 | 8.77 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-FIM: Day 01 | 2.32 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-PT: Day 31 | 41.4 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-FHA: Day 01 | 44.5 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-FHA: Day 31 | 146 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-PRN: Day 01 | 11.4 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-PRN: Day 31 | 236 EU/mL |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-FIM: Day 31 | 106 EU/mL |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PT: Day 31 | 11.9 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PT: Day 61 | 58.4 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FHA: Day 31 | 47.3 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FHA: Day 61 | 177 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PRN: Day 31 | 14.5 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PRN: Day 61 | 331 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FIM: Day 31 | 2.74 Endotoxin units per milliliter (EU/mL) |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FIM: Day 61 | 152 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FIM: Day 61 | 194 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PT: Day 31 | 12.3 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PRN: Day 31 | 18.2 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PT: Day 61 | 59.3 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FIM: Day 31 | 3.18 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FHA: Day 31 | 58.3 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-PRN: Day 61 | 394 Endotoxin units per milliliter (EU/mL) |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-FHA: Day 61 | 210 Endotoxin units per milliliter (EU/mL) |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Polio type 1: Day 01 | 146 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Polio type 1: Day 31 | 1593 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Polio type 2: Day 01 | 225 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Polio type 2: Day 31 | 2950 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Polio type 3: Day 01 | 221 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Anti-Polio Antibodies Contained in Tetanus, Diphtheria, and Acellular Pertussis - Inactivated Polio Vaccine (Tdap-IPV) Vaccine: Group 3 | Anti-Polio type 3: Day 31 | 3166 titers |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 1: Day 61 | 3135 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 2: Day 61 | 3344 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 1: Day 31 | 94.7 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 3: Day 31 | 135 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 2: Day 31 | 227 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 3: Day 61 | 7059 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 3: Day 61 | 5591 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 1: Day 31 | 109 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 1: Day 61 | 3266 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 2: Day 31 | 234 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 2: Day 61 | 2648 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio type 3: Day 31 | 155 titers |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 2 | 13.1 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 3 | 14.3 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Tetanus | 48.7 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | 11.4 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 1 | 10.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-PT | 4.72 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-FHA | 3.27 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-PRN | 20.6 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-FIM | 45.7 ratio |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | 18.5 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-PT | 4.90 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 2 | 14.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-FHA | 3.76 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 1 | 32.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-PRN | 22.4 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 3 | 51.8 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-FIM | 55.3 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Tetanus | 0.677 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-FIM | 61.2 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Tetanus | 0.876 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | 18.1 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 1 | 29.5 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 2 | 11.3 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-Polio type 3 | 36.1 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-PT | 4.83 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-FHA | 3.61 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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-PRN | 21.6 ratio |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-58: Day 01 | 1.08 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-6: Day 01 | 2.12 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-6: Day 31 | 50.6 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-11: Day 01 | 1.07 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-11: Day 31 | 36.3 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-16: Day 01 | 2.02 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-16: Day 31 | 146 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-18: Day 01 | 1.50 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-18: Day 31 | 31.2 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-31: Day 01 | 1.07 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-31: Day 31 | 24.7 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-33: Day 01 | 1.01 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-33: Day 31 | 15.0 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-45: Day 01 | 0.524 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-45: Day 31 | 8.24 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-52: Day 01 | 0.521 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-52: Day 31 | 40.9 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-58: Day 31 | 20.6 titers |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-31: Day 61 | 31.7 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-6: Day 61 | 73.9 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-33: Day 31 | 1.01 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-16: Day 31 | 2.06 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-33: Day 61 | 21.1 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-6: Day 31 | 2.30 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-45: Day 31 | 0.520 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-16: Day 61 | 199 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-45: Day 61 | 11.5 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-11: Day 31 | 1.11 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-52: Day 31 | 0.535 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-18: Day 61 | 46.5 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-52: Day 61 | 47.4 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-18: Day 31 | 1.59 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-58: Day 31 | 1.09 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-31: Day 31 | 1.08 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-58: Day 61 | 29.6 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-11: Day 61 | 43.9 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-58: Day 61 | 26.0 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-6: Day 31 | 2.03 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-6: Day 61 | 64.8 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-11: Day 31 | 1.08 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-11: Day 61 | 39.3 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-16: Day 31 | 2.08 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-18: Day 31 | 1.52 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-18: Day 61 | 38.5 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-31: Day 31 | 1.05 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-31: Day 61 | 28.9 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-33: Day 31 | 1.02 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-33: Day 61 | 19.1 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-45: Day 31 | 0.509 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-45: Day 61 | 9.54 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-52: Day 31 | 0.514 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-52: Day 61 | 39.3 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-58: Day 31 | 1.05 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-16: Day 61 | 168 titers |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 01 | 7.30 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 31 | 4222 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 01 | 7.06 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 31 | 2361 titers |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 01 | 6.95 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 31 | 78.2 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 01 | 6.40 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 31 | 2294 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 01 | 2.56 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 31 | 169 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 01 | 3.76 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 31 | 134 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 01 | 5.51 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 01 | 4.36 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 31 | 619 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 01 | 3.14 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 31 | 84.8 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 01 | 6.41 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 31 | 56.0 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 31 | 64.6 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 01 | 5.67 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 31 | 42.2 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 01 | 7.38 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 31 | 1938 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 01 | 3.98 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 31 | 171 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 01 | 2.43 titers |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 31 | 74.6 titers |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 01 | 6.51 titers |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 31 | 19760 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 01 | 3.32 titers |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Day 31 | 7052 titers |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-58 | 19.1 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-6 | 23.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-11 | 33.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-16 | 71.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-18 | 20.8 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-31 | 23.1 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-33 | 14.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-45 | 15.7 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine: Group 3 | Anti-HPV type-52 | 78.4 ratio |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: Analysis was performed on PPASC. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-6 | 32.0 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-33 | 20.8 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-16 | 96.6 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-45 | 21.9 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-18 | 29.7 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-52 | 88.0 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-11 | 39.0 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-58 | 27.1 ratio |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-31 | 29.8 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-58 | 24.8 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-6 | 31.9 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-11 | 36.5 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-18 | 25.4 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-31 | 27.5 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-33 | 18.7 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-45 | 18.8 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-52 | 76.5 ratio |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Geometric Mean Titers Ratios (GMTRs) of Antibodies Against Antigens Contained in Human Papillomavirus (HPV) Vaccine in Groups 1 and 2 | Anti-HPV type-16 | 80.8 ratio |
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.
Time frame: Within 30 minutes post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 0 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 0 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 0 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 0 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 0 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 0 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 0 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Post-any vaccination | 0 Participants |
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.
Time frame: From Day 01 up to the last study day (i.e., Day 61 for Groups 1 and 2 and Day 31 for Group 3)
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | SAE | 0 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | AESI | 0 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | SAE | 1 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | AESI | 0 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | SAE | 0 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Events of Special Interest (AESI) | AESI | 0 Participants |
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.
Time frame: Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Pain: Post-any vaccination | 116 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Pain: Post-any vaccination | 91 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Pain: Post-vaccination 2 | 113 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Erythema: Post-any vaccination | 9 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Erythema: Post-any vaccination | 19 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Swelling: Post-vaccination 1 | 17 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Swelling: Post-any vaccination | 9 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Swelling: Post-vaccination 2 | 9 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Erythema: Post-vaccination 1 | 19 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Pain: Post-vaccination 1 | 91 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Pain: Post-any vaccination | 113 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Erythema: Post-any vaccination | 7 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Pain: Post-vaccination 2 | 116 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Swelling: Post-any vaccination | 17 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Swelling: Post-vaccination 2 | 4 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Swelling: Post-any vaccination | 4 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Erythema: Post-vaccination 2 | 9 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Erythema: Post-vaccination 2 | 7 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Swelling: Post-vaccination 2 | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Nimenrix vaccine: Pain: Post-any vaccination | 87 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Nimenrix vaccine: Erythema: Post-any vaccination | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Nimenrix vaccine: Swelling: Post-any vaccination | 7 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Pain: Post-any vaccination | 125 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Erythema: Post-any vaccination | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Swelling: Post-any vaccination | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Pain: Post-any vaccination | 117 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Erythema: Post-any vaccination | 5 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Swelling: Post-any vaccination | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Nimenrix vaccine: Pain: Post-vaccination 1 | 87 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Nimenrix vaccine: Erythema: Post-vaccination 1 | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Nimenrix vaccine: Swelling: Post-vaccination 1 | 7 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Pain: Post-vaccination 2 | 125 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Erythema: Post-vaccination 2 | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Swelling: Post-vaccination 2 | 3 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Pain: Post-vaccination 2 | 117 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Erythema: Post-vaccination 2 | 5 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Pain: Post-vaccination 1 | 97 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Erythema: Post-vaccination 1 | 6 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Swelling: Post-vaccination 1 | 7 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Pain: Post-vaccination 1 | 95 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Erythema: Post-vaccination 1 | 13 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Swelling: Post-vaccination 1 | 10 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Pain: Post-any vaccination | 95 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Erythema: Post-any vaccination | 11 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Swelling: Post-any vaccination | 7 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Swelling: Post-any vaccination | 12 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Pain: Post-vaccination 1 | 69 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Swelling: Post-any vaccination | 10 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Erythema: Post-vaccination 1 | 11 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | Tdap-IPV: Erythema: Post-any vaccination | 13 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Swelling: Post-vaccination 1 | 12 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Erythema: Post-any vaccination | 6 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | MenACYW Conjugate vaccine: Pain: Post-any vaccination | 69 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions | 9vHPV: Pain: Post-any vaccination | 97 Participants |
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.
Time frame: Within 7 days post-any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 31])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-any vaccination | 12 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-any vaccination | 75 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-any vaccination | 65 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-any vaccination | 84 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-vaccination 1 | 7 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-vaccination 1 | 59 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-vaccination 1 | 46 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-vaccination 1 | 51 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-vaccination 2 | 6 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-vaccination 2 | 37 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-vaccination 2 | 40 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-vaccination 2 | 67 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-any vaccination | 81 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-vaccination 2 | 7 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-vaccination 1 | 32 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-any vaccination | 11 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-vaccination 2 | 26 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-any vaccination | 64 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-vaccination 2 | 61 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-any vaccination | 48 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-vaccination 1 | 53 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-vaccination 1 | 4 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-vaccination 2 | 40 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-vaccination 1 | 44 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-vaccination 1 | 67 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-any vaccination | 52 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-vaccination 1 | 6 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-any vaccination | 42 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Fever: Post-any vaccination | 6 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Headache: Post-vaccination 1 | 52 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Malaise: Post-vaccination 1 | 42 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions | Myalgia: Post-any vaccination | 67 Participants |
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.
Time frame: 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])
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 49 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-any vaccination | 69 Participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 34 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-vaccination 2 | 27 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-any vaccination | 49 Participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 31 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-vaccination 1 | 37 Participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Post-any vaccination | 37 Participants |
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.
Time frame: From Baseline (Day 01) to Day 31 (post-vaccination)
Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup A | 88.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup C | 99.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y | 98.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup W | 94.3 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup W | 88.2 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup A | 76.1 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y | 92.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup C | 91.9 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup W | 86.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup C | 97.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y | 99.1 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W | Serogroup A | 65.2 percentage of participants |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on PPASC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 01: >=0.1 | 96.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 01: >=1.0 | 38.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 31: >=0.1 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 31: >=1.0 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 01: >=0.1 | 85.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 01: >=1.0 | 9.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 31: >=0.1 | 99.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 31: >=1.0 | 90.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 1: Day 01: >=8 | 99.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 1: Day 31: >=8 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 2: Day 01: >=8 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 2: Day 31: >=8 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 3: Day 01: >=8 | 96.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 3: Day 31: >=8 | 100 percentage of participants |
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.
Time frame: Day 31 (post-vaccination) and Day 61 (post-vaccination)
Population: Analysis was performed on PPASC. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 31: >=0.1 | 76.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 31: >=1.0 | 4.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 1: Day 31: >=8 | 95.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 1: Day 61: >=8 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 3: Day 31: >=8 | 95.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 61: >=0.1 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 61: >=1.0 | 93.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 2: Day 31: >=8 | 99.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 2: Day 61: >=8 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 3: Day 61: >=8 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 31: >=0.1 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 31: >=1.0 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 61: >=0.1 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 61: >=1.0 | 99.3 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 31: >=1.0 | 98.0 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 2: Day 61: >=8 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 61: >=0.1 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 3: Day 31: >=8 | 96.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 61: >=1.0 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 3: Day 61: >=8 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 31: >=1.0 | 4.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 61: >=0.1 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-T: Day 31: >=0.1 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 61: >=1.0 | 92.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 1: Day 31: >=8 | 95.2 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 1: Day 61: >=8 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-D: Day 31: >=0.1 | 79.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | 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 | Anti-Polio 2: Day 31: >=8 | 100 percentage of participants |
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.
Time frame: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:4: Day 01 | 61.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:8: Day 01 | 56.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:4: Day 31 | 98.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:8: Day 31 | 97.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:4: Day 01 | 94.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:8: Day 01 | 41.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:4: Day 31 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:8: Day 31 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:4: Day 01 | 14.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:8: Day 01 | 9.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:4: Day 31 | 99.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:8: Day 31 | 99.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:4: Day 01 | 39.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:8: Day 01 | 22.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:4: Day 31 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:8: Day 31 | 100 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:8: Day 01 | 35.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:4: Day 31 | 96.3 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:8: Day 31 | 95.0 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:8: Day 01 | 28.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:4: Day 01 | 17.4 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:8: Day 01 | 15.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:8: Day 31 | 98.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:4: Day 31 | 98.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:4: Day 01 | 88.1 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:4: Day 31 | 98.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:8: Day 01 | 50.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:8: Day 31 | 98.1 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:4: Day 31 | 95.0 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:8: Day 31 | 92.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:4: Day 01 | 61.3 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:4: Day 01 | 46.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:4: Day 31 | 100 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:8: Day 01 | 41.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:4: Day 01 | 30.4 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:4: Day 31 | 96.5 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:4: Day 31 | 99.1 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:8: Day 31 | 99.1 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:4: Day 01 | 83.9 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:8: Day 31 | 99.1 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:8: Day 31 | 100 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >= 1:4: Day 01 | 57.5 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:4: Day 01 | 8.8 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:8: Day 01 | 26.8 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:8: Day 01 | 58.9 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >= 1:8: Day 01 | 6.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >= 1:8: Day 31 | 91.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >= 1:4: Day 31 | 100 percentage of participants |
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.
Time frame: Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)
Population: Analysis was performed on PPASC. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-58 | 95.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-18 | 94.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-16 | 99.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-52 | 99.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-31 | 96.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-11 | 99.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-45 | 81.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-33 | 95.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-6 | 87.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-33 | 91.8 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-45 | 83.0 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-6 | 88.4 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-52 | 98.0 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-16 | 96.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-58 | 92.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-11 | 97.3 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-18 | 92.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-31 | 93.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-58 | 92.0 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-16 | 98.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-6 | 85.0 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-11 | 97.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-18 | 88.5 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-31 | 88.5 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-33 | 87.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-45 | 75.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroconversion Against Antigens Contained in Human Papillomavirus (HPV) Vaccine | Anti-HPV type-52 | 96.5 percentage of participants |
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.
Time frame: Day 31 (post-vaccination)
Population: Analysis was performed on hSBA PPASM. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup A | 88.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup C | 99.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y | 98.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup W | 93.1 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup W | 81.4 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup A | 75.5 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y | 88.1 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup C | 88.8 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup W | 85.7 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup C | 97.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y | 99.1 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W | Serogroup A | 63.4 percentage of participants |
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.
Time frame: Day 61 (post-vaccination for Groups 1 and 2) and Day 31 (post-vaccination for Group 3)
Population: Analysis was performed on PPASC. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-PT | 81.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-FHA | 74.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-PRN | 98.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-FIM | 93.9 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-FIM | 97.3 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-PT | 83.0 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-PRN | 94.6 percentage of participants |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-FHA | 76.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-FIM | 95.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-FHA | 70.8 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-PRN | 91.2 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | Percentage of Participants With Vaccine Seroresponse Against Pertussis Antigens | Anti-PT | 76.1 percentage of participants |