Infections, Meningococcal
Conditions
Keywords
Meningococcal Serogroups A, C, W-135 and/or Y Disease
Brief summary
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.
Detailed description
Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (\< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old). This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to \< 11 years of age.
Interventions
BIOLOGICALMeningococcal vaccine 134612
Single dose intramuscular injection.
BIOLOGICALMenactra®
Single dose intramuscular injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects whom the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination. * Written informed consent obtained from parents/guardian 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 has achieved the 18th birthday. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). * Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y. * Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month). * History of meningococcal disease due to serogroup A, C, W-135, or Y. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required). * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Previous history of Guillain-Barré Syndrome. * Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy. * Acute disease at the time of enrollment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | At Day 0 (PRE) | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. |
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | At Month 1 | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period | Assessed solicited general symptoms were fatigue, fever \[defined as orally temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) follow-up period after vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | At Day 0 (PRE) and Month 1 | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4. |
| Number of Subjects With New Onset Chronic Illness(es) (NOCI) | From Day 0 to Month 6 | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Rash | From Day 0 to Month 6 | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | From Day 0 to Month 6 | — |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Month 6 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | At Day 0 (PRE) and Month 1 | Antibody titers are presented as geometric mean titers (GMTs). |
Countries
United States
Participant flow
Recruitment details
Out of the 873 subjects enrolled in the study, only 872 subjects received the vaccination course and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix 11-25Y Group Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm. | 587 |
| Menactra Group Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm. | 197 |
| Nimenrix 10Y Group Subjects, male or female, aged 10 years (\<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm. | 88 |
| Total | 872 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to follow-up (complete vaccination) | 5 | 3 | 1 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 1 |
| Overall Study | Others | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Nimenrix 11-25Y Group | Menactra Group | Nimenrix 10Y Group | Total |
|---|---|---|---|---|
| Age, Continuous | 14.8 Years STANDARD_DEVIATION 2.69 | 14.7 Years STANDARD_DEVIATION 2.78 | 10 Years STANDARD_DEVIATION 0 | 14.29 Years STANDARD_DEVIATION 2.95 |
| Race/Ethnicity, Customized African heritage/African American | 35 Participants | 12 Participants | 9 Participants | 56 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 49 Participants | 21 Participants | 9 Participants | 79 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 5 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian-East Asian heritage | 17 Participants | 1 Participants | 5 Participants | 23 Participants |
| Race/Ethnicity, Customized Asian-Japanese heritage | 7 Participants | 4 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 40 Participants | 14 Participants | 8 Participants | 62 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Unspecified | 138 Participants | 43 Participants | 20 Participants | 201 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 290 Participants | 95 Participants | 34 Participants | 419 Participants |
| Sex: Female, Male Female | 274 Participants | 101 Participants | 51 Participants | 426 Participants |
| Sex: Female, Male Male | 313 Participants | 96 Participants | 37 Participants | 446 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 587 | 0 / 197 | 0 / 88 |
| other Total, other adverse events | 438 / 587 | 142 / 197 | 68 / 88 |
| serious Total, serious adverse events | 5 / 587 | 2 / 197 | 2 / 88 |
Outcome results
Primary
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time frame: At Day 0 (PRE)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 49 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 275 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 114 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 269 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 94 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 13 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 51 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 113 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 31 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 40 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 11 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 5 Participants |
Primary
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time frame: At Month 1
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 415 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 490 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 438 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 492 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 139 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 118 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 114 Participants |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 171 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY | 76 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC | 78 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 | 73 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA | 70 Participants |
Comparison: Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.95% CI: [3.87, 19.18]
Comparison: Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.95% CI: [-5.08, 0.4]
Comparison: Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.95% CI: [8.24, 22.71]
Comparison: Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.95% CI: [7.9, 20.1]
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: At Day 0 (PRE) and Month 1
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, PRE | 2.6 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, Month 1 | 57.2 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, PRE | 12.8 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, Month 1 | 506.7 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, PRE | 5.7 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, Month 1 | 124.2 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, PRE | 22.6 Titers |
| Nimenrix 11-25Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, Month 1 | 260.0 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, PRE | 17.9 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, PRE | 27.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, Month 1 | 285.8 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, PRE | 8.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, Month 1 | 74.1 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, PRE | 2.4 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, Month 1 | 36.0 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, Month 1 | 110.6 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, PRE | 9.7 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, Month 1 | 91.5 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenA, PRE | 2.4 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenC, Month 1 | 765.9 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, PRE | 13.7 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, Month 1 | 153.8 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenW-135, PRE | 4.2 Titers |
| Nimenrix 10Y Group | hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers | hSBA-MenY, Month 1 | 315.0 Titers |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: From Day 0 to Month 6
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 24 Participants |
| Menactra Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 9 Participants |
| Nimenrix 10Y Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 2 Participants |
Secondary
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From Day 0 to Month 6
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects Reporting Rash | 14 Participants |
| Menactra Group | Number of Subjects Reporting Rash | 3 Participants |
| Nimenrix 10Y Group | Number of Subjects Reporting Rash | 2 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, D0-7 | 9 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, D0-3 | 317 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, D0-7 | 77 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3, D0-3 | 9 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3, D0-7 | 9 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, D0-7 | 63 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3, D0-7 | 11 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, D0-3 | 9 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, D0-3 | 62 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3, D0-3 | 11 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, D0-7 | 318 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, D0-3 | 77 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, D0-3 | 21 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, D0-7 | 2 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, D0-3 | 13 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, D0-7 | 21 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, D0-3 | 2 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, D0-7 | 105 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3, D0-7 | 0 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3, D0-3 | 0 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3, D0-3 | 1 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, D0-7 | 13 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, D0-3 | 105 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3, D0-7 | 1 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3, D0-7 | 3 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, D0-3 | 48 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, D0-3 | 0 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, D0-3 | 15 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3, D0-3 | 2 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, D0-3 | 18 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Grade 3, D0-3 | 3 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, D0-7 | 18 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, D0-7 | 48 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, D0-7 | 0 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, D0-7 | 15 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Grade 3, D0-7 | 2 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as orally temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Any, D0-3 | 87 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, D0-3 | 10 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, D0-3 | 139 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, D0-3 | 34 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, D0-3 | 0 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, D0-3 | 28 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, D0-3 | 156 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Grade 3, D0-3 | 4 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Related, D0-3 | 74 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, D0-3 | 161 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, D0-3 | 11 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, D0-3 | 139 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, D0-7 | 172 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, D0-7 | 19 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, D0-7 | 147 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, D0-7 | 41 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, D0-7 | 1 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, D0-7 | 29 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Any, D0-7 | 109 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Grade 3, D0-7 | 8 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Related, D0-7 | 86 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, D0-7 | 191 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, D0-7 | 16 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, D0-7 | 157 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, D0-7 | 72 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, D0-3 | 55 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, D0-7 | 62 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, D0-7 | 0 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, D0-3 | 2 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, D0-3 | 1 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Related, D0-7 | 24 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, D0-3 | 49 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, D0-7 | 4 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, D0-7 | 2 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, D0-3 | 11 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, D0-3 | 60 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, D0-7 | 13 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, D0-3 | 0 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, D0-7 | 53 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, D0-3 | 51 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, D0-3 | 9 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Related, D0-3 | 22 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, D0-7 | 57 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Any, D0-3 | 26 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, D0-7 | 16 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Any, D0-7 | 32 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Grade 3, D0-3 | 2 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Grade 3, D0-7 | 3 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Grade 3, D0-3 | 0 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Related, D0-3 | 9 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, D0-3 | 27 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, D0-3 | 1 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Grade 3, D0-7 | 2 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, D0-3 | 21 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, D0-7 | 2 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, D0-7 | 27 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, D0-7 | 3 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Related, D0-7 | 9 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, D0-7 | 23 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, D0-7 | 24 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, D0-7 | 7 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, D0-3 | 24 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, D0-3 | 3 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, D0-7 | 0 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, D0-3 | 21 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, D0-7 | 30 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, D0-3 | 6 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, D0-3 | 0 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, D0-7 | 6 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, D0-3 | 5 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Any, D0-3 | 11 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal symptoms, Any, D0-7 | 15 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period after vaccination
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 104 Participants |
| Menactra Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 37 Participants |
| Nimenrix 10Y Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 13 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: At Day 0 (PRE) and Month 1
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, PRE | 68 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, Month 1 | 421 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PRE | 276 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, Month 1 | 490 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PRE | 118 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, Month 1 | 441 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PRE | 273 Participants |
| Nimenrix 11-25Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, Month 1 | 492 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PRE | 114 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PRE | 94 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, Month 1 | 171 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PRE | 51 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, Month 1 | 117 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, PRE | 18 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, Month 1 | 118 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, Month 1 | 139 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PRE | 40 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, Month 1 | 71 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, PRE | 7 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, Month 1 | 78 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PRE | 32 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, Month 1 | 73 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PRE | 11 Participants |
| Nimenrix 10Y Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, Month 1 | 76 Participants |
Secondary
Number of Subjects With New Onset Chronic Illness(es) (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 to Month 6
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With New Onset Chronic Illness(es) (NOCI) | 8 Participants |
| Menactra Group | Number of Subjects With New Onset Chronic Illness(es) (NOCI) | 2 Participants |
| Nimenrix 10Y Group | Number of Subjects With New Onset Chronic Illness(es) (NOCI) | 1 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 to Month 6
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 11-25Y Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| Menactra Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Nimenrix 10Y Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |