Infections, Papillomavirus
Conditions
Keywords
HPV, HPV, diptheria, pertussis, tetanus, meningitis
Brief summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALBoostrix TM
One dose of vaccine administered intramuscularly
BIOLOGICALDifferent formulations of GSK Biologicals' HPV vaccine (580299)
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
BIOLOGICALMenactra TM
One dose of vaccine administered intramuscularly
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 11 and 18 years of age at the time of the first vaccination. * Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age. * Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study. * Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time. * Subjects must have a negative urine pregnancy test. * Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * Pregnant or breastfeeding women. * Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * previous administration of components of the investigational vaccine * Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years. * Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years. * Previous vaccination against Neisseria meningitidis. * Hypersensitivity to latex. * Cancer or autoimmune disease under treatment. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine. * History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause. * Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy. * Temperature of \>= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause. * Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine. * Seizures with or without fever within three days of a prior dose of DTP vaccine. * Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years. * Previous history of Guillain-Barré syndrome. * Any confirmed or suspected immunosuppressive or immunodeficient condition * Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Before and one month after vaccination with Boostrix | Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL) |
| Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Before and one month after vaccination with Boostrix | Concentrations given as Geometric Means Concentrations (GMCs) |
| Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Before and one month after vaccination with Menactra | Titers given as Geometric Mean Titers (GMTs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Booster Response for Anti-D and Anti-T | One month after vaccination with Boostrix | Booster responses for anti-D and anti-T defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off: \< 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL) * For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer |
| Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | One month after vaccination with Boostrix | Booster responses defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off: \< 5 EL.U/mL): antibody titers at least 4 times the cut-off, * For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer, * For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer |
| Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | One month after vaccination with Menactra | Vaccine responses for anti-A, C, Y and W-135 defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32) * For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer |
| Number of Subjects Reporting Solicited Local Symptoms | During the 7-day period following each vaccination | Solicited local symptoms assessed include pain, redness and swelling. |
| Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12) | Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | During the 30-day period following each vaccination | Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. |
| Number of Subjects Reporting Serious Adverse Events | During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13) | Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13) | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes |
| Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13) | Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases. |
| Number of Subjects Reporting Solicited General Symptoms | During the 7-day period following each vaccination | Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria |
| Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Before and one month after vaccination with Boostrix | Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL) |
| Concentration of Anti-D and Anti-T Antibodies | Before and one month after vaccination with Boostrix | Concentrations given as Geometric Mean Concentrations (GMCs) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervarix + Boostrix/Menactra Group Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6. | 212 |
| Cervarix + Menactra/Boostrix Group Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6. | 214 |
| Cervarix + Boostrix + Menactra Group Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6. | 214 |
| Boostrix/Cervarix Group Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7. | 214 |
| Menactra/Cervarix Group Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7. | 214 |
| Cervarix Group Subjects received Cervarix at Months 0, 1 and 6. | 215 |
| Total | 1,283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 11 | 7 | 8 | 9 | 6 |
| Overall Study | Other | 0 | 0 | 0 | 2 | 1 | 3 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 5 | 5 | 4 | 6 | 2 |
Baseline characteristics
| Characteristic | Total | Cervarix + Boostrix/Menactra Group | Cervarix + Menactra/Boostrix Group | Cervarix + Boostrix + Menactra Group | Boostrix/Cervarix Group | Menactra/Cervarix Group | Cervarix Group |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 13.4 years STANDARD_DEVIATION 2.3 | 13.5 years STANDARD_DEVIATION 2.27 | 13.3 years STANDARD_DEVIATION 2.28 | 13.5 years STANDARD_DEVIATION 2.26 | 13.5 years STANDARD_DEVIATION 2.33 | 13.3 years STANDARD_DEVIATION 2.35 | 13.4 years STANDARD_DEVIATION 2.34 |
| Sex: Female, Male Female | 1283 Participants | 212 Participants | 214 Participants | 214 Participants | 214 Participants | 214 Participants | 215 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 202 / 212 | 207 / 214 | 205 / 214 | 208 / 214 | 202 / 214 | 203 / 215 |
| serious Total, serious adverse events | 1 / — | 3 / — | 4 / — | 0 / — | 7 / — | 4 / — |
Outcome results
Primary
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Concentrations given as Geometric Means Concentrations (GMCs)
Time frame: Before and one month after vaccination with Boostrix
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-FHA (1month after vaccination) | 648.018 International Units per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PT (Before vaccination) | 9.515 International Units per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-FHA (Before vaccination) | 32.472 International Units per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PRN(1month after vaccination) | 416.049 International Units per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PRN (Before vaccination) | 12.978 International Units per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PT (1month after vaccination) | 74.682 International Units per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-FHA (Before vaccination) | 37.671 International Units per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PT (Before vaccination) | 10.356 International Units per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PT (1month after vaccination) | 70.908 International Units per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-FHA (1month after vaccination) | 544.665 International Units per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PRN (Before vaccination) | 16.040 International Units per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PRN(1month after vaccination) | 323.205 International Units per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PT (Before vaccination) | 11.164 International Units per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PRN(1month after vaccination) | 379.467 International Units per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PRN (Before vaccination) | 15.871 International Units per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-PT (1month after vaccination) | 78.807 International Units per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-FHA (Before vaccination) | 38.819 International Units per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies | Anti-FHA (1month after vaccination) | 676.765 International Units per Milliliter |
Primary
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Time frame: Before and one month after vaccination with Boostrix
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-D (Before vaccination) | 38 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-T (1 month after vaccination) | 194 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-D (1 month after vaccination) | 193 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-T (Before vaccination) | 75 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-D (1 month after vaccination) | 200 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-T (Before vaccination) | 75 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-T (1 month after vaccination) | 201 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-D (Before vaccination) | 33 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-T (1 month after vaccination) | 198 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-D (Before vaccination) | 39 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-D (1 month after vaccination) | 190 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) | Anti-T (Before vaccination) | 72 Participants |
Primary
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Titers given as Geometric Mean Titers (GMTs)
Time frame: Before and one month after vaccination with Menactra
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-A (Before vaccination) | 898.650 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-W135 (Before vaccination) | 33.946 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-C (1month after vaccination) | 2497.463 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-A (1month after vaccination) | 7570.228 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-Y (1month after vaccination) | 4787.556 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-W135(1month after vaccination) | 4564.037 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-C (Before vaccination) | 37.738 Titer |
| Cervarix + Menactra/Boostrix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-Y (Before vaccination) | 87.356 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-A (1month after vaccination) | 6919.419 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-C (Before vaccination) | 35.827 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-W135(1month after vaccination) | 3856.584 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-A (Before vaccination) | 829.508 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-C (1month after vaccination) | 2112.366 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-Y (Before vaccination) | 72.756 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-Y (1month after vaccination) | 3947.330 Titer |
| Cervarix + Boostrix + Menactra Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-W135 (Before vaccination) | 28.750 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-A (1month after vaccination) | 8352.685 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-Y (Before vaccination) | 110.911 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-C (Before vaccination) | 30.696 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-W135 (Before vaccination) | 34.206 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-A (Before vaccination) | 763.324 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-Y (1month after vaccination) | 4335.380 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-C (1month after vaccination) | 2375.963 Titer |
| Menactra/Cervarix Group | Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies | Anti-W135(1month after vaccination) | 5056.182 Titer |
Secondary
Concentration of Anti-D and Anti-T Antibodies
Concentrations given as Geometric Mean Concentrations (GMCs)
Time frame: Before and one month after vaccination with Boostrix
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-D (Before vaccination) | 0.362 International Unit per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-D (1month after vaccination) | 8.928 International Unit per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-T (Before vaccination) | 0.811 International Unit per Milliliter |
| Cervarix + Boostrix/Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-T (1month after vaccination) | 15.584 International Unit per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-T (1month after vaccination) | 12.415 International Unit per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-D (Before vaccination) | 0.368 International Unit per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-T (Before vaccination) | 0.895 International Unit per Milliliter |
| Cervarix + Boostrix + Menactra Group | Concentration of Anti-D and Anti-T Antibodies | Anti-D (1month after vaccination) | 27.438 International Unit per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-D and Anti-T Antibodies | Anti-T (1month after vaccination) | 14.524 International Unit per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-D and Anti-T Antibodies | Anti-D (1month after vaccination) | 7.527 International Unit per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-D and Anti-T Antibodies | Anti-T (Before vaccination) | 0.700 International Unit per Milliliter |
| Boostrix/Cervarix Group | Concentration of Anti-D and Anti-T Antibodies | Anti-D (Before vaccination) | 0.331 International Unit per Milliliter |
Secondary
Number of Subjects Reporting Medically Significant Adverse Events (AEs)
Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
Time frame: During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase | 40 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the entire study | 43 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase | 43 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the entire study | 46 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase | 51 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the entire study | 54 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase | 56 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the entire study | 59 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase | 62 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the entire study | 64 Participants |
| Cervarix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the active phase | 59 Participants |
| Cervarix Group | Number of Subjects Reporting Medically Significant Adverse Events (AEs) | During the entire study | 64 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events
Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Serious Adverse Events | During the active phase | 0 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Serious Adverse Events | During the entire study | 1 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Serious Adverse Events | During the entire study | 3 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Serious Adverse Events | During the active phase | 2 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Serious Adverse Events | During the active phase | 3 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Serious Adverse Events | During the entire study | 4 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Serious Adverse Events | During the active phase | 0 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Serious Adverse Events | During the entire study | 0 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Serious Adverse Events | During the entire study | 7 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Serious Adverse Events | During the active phase | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Serious Adverse Events | During the entire study | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Serious Adverse Events | During the active phase | 4 Participants |
Secondary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria
Time frame: During the 7-day period following each vaccination
Population: Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 107 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal | 59 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 80 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 7 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 11 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 94 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 31 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 37 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 42 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 12 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 32 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 100 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 5 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal | 62 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 89 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 118 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 12 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 34 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 101 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 124 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal | 70 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 24 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 19 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 111 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 15 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 7 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 48 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 118 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal | 65 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 28 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 133 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 96 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 35 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 13 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 66 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 99 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal | 65 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 33 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 4 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 122 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal | 69 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 47 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 98 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 23 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 112 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 89 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 13 Participants |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: During the 7-day period following each vaccination
Population: Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 97 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 94 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 197 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 93 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 204 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 90 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 103 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 204 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 102 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 100 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 203 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 103 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 193 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 99 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 74 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 201 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 93 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 86 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: During the 30-day period following each vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 108 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 121 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 119 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 122 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 127 Participants |
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 118 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes
Time frame: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase | 3 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the entire study | 3 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase | 6 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the entire study | 6 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase | 6 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the entire study | 6 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase | 5 Participants |
| Boostrix/Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the entire study | 6 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase | 11 Participants |
| Menactra/Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the entire study | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the active phase | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) | During the entire study | 6 Participants |
Secondary
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Vaccine responses for anti-A, C, Y and W-135 defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32) * For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer
Time frame: One month after vaccination with Menactra
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-Y | 169 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-A | 127 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-W135 | 176 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-C | 162 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-Y | 166 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-C | 163 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-A | 112 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-W135 | 183 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-C | 161 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-A | 139 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-W135 | 181 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response | Anti-Y | 171 Participants |
Secondary
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)
Time frame: Before and one month after vaccination with Boostrix
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-T (Before vaccination) | 188 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-D (1month after vaccination) | 194 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-T (1month after vaccination) | 194 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-D (Before vaccination) | 170 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-T (1month after vaccination) | 201 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-D (Before vaccination) | 181 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-D (1month after vaccination) | 201 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-T (Before vaccination) | 199 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-D (1month after vaccination) | 199 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-T (1month after vaccination) | 199 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-D (Before vaccination) | 167 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) | Anti-T (Before vaccination) | 195 Participants |
Secondary
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.
Time frame: Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth2 | 163 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 PRE | 14 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth12 | 163 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth12 | 163 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth7 | 161 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 PRE | 19 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth7 | 161 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth2 | 163 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth7 | 158 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth12 | 158 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 PRE | 8 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth2 | 158 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth2 | 157 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 PRE | 10 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth12 | 157 Participants |
| Cervarix + Menactra/Boostrix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth7 | 157 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth7 | 164 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth7 | 165 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth12 | 165 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth2 | 163 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 PRE | 9 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth2 | 164 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth12 | 164 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 PRE | 13 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth7 | 156 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth2 | 156 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth2 | 152 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 PRE | 8 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth12 | 152 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth7 | 152 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 PRE | 5 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth12 | 156 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth2 | 145 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 PRE | 11 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth7 | 142 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth12 | 146 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 PRE | 6 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth2 | 146 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth7 | 143 Participants |
| Menactra/Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth12 | 147 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth12 | 165 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth7 | 163 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth12 | 166 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth2 | 166 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 PRE | 11 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV16 Mth7 | 164 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 Mth2 | 165 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values | Anti-HPV18 PRE | 11 Participants |
Secondary
Number of Subjects With Booster Response for Anti-D and Anti-T
Booster responses for anti-D and anti-T defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off: \< 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL) * For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer
Time frame: One month after vaccination with Boostrix
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Booster Response for Anti-D and Anti-T | Anti-D | 175 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Booster Response for Anti-D and Anti-T | Anti-T | 157 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Booster Response for Anti-D and Anti-T | Anti-D | 196 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Booster Response for Anti-D and Anti-T | Anti-T | 162 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Booster Response for Anti-D and Anti-T | Anti-D | 182 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Booster Response for Anti-D and Anti-T | Anti-T | 168 Participants |
Secondary
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Booster responses defined as: * For initially seronegative subjects (pre-vaccination titer below cut-off: \< 5 EL.U/mL): antibody titers at least 4 times the cut-off, * For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer, * For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer
Time frame: One month after vaccination with Boostrix
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 167 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 138 Participants |
| Cervarix + Boostrix/Menactra Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 183 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 163 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 116 Participants |
| Cervarix + Boostrix + Menactra Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 180 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 133 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 177 Participants |
| Boostrix/Cervarix Group | Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 165 Participants |