Infections, Meningococcal
Conditions
Keywords
Adolescent, Vaccine, conjugate, Adult, Neisseria meningitidis, Immunogenicity, Meningococcal vaccine, Safety
Brief summary
The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.
Interventions
BIOLOGICALMencevax ACWY
One dose, Subcutaneous injection
BIOLOGICALGSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
One dose, Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy all of the following criteria at study entry: * Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study. * A male or female between, and including, 18 and 25 years of age the time of the vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.
Exclusion criteria
The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study: * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone \<10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed). * Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine. * Previous vaccination with meningococcal polysaccharide vaccine within the last five years. * Previous vaccination with meningococcal conjugate vaccine. * Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month. * History of meningococcal disease. * Seropositive for HIV or HBsAg (for subjects in the Philippines only). * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient has been demonstrated. * History of reactions or allergic disease likely to be exacerbated by any component of either vaccine. * History of any neurologic disorders, including Guillain-Barré Syndrome. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the 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. * Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | At Month 1 | Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | At Month 1 | Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | At Day 0 and at Month 1 | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the GSK rSBA assay. |
| Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | At Month 1 | Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the Health Protection Agency (HPA) rSBA assay. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4-days (Days 0-3) post-vaccination | 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 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | At Day 0 and at Month 1 | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Days 0-30) post-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 New Onset Chronic Illnesses (NOCI) | Within 31-days (Days 0-30) post-vaccination | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 4-days (Days 0-3) post-vaccination | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature \[defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | At Day 0 and at Month 1 | Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay. |
Countries
Panama, Philippines, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix-A Group Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm. | 390 |
| Nimenrix-B Group Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm. | 390 |
| Mencevax Group Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm. | 390 |
| Total | 1,170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 6 | 7 |
Baseline characteristics
| Characteristic | Nimenrix-A Group | Nimenrix-B Group | Mencevax Group | Total |
|---|---|---|---|---|
| Age, Continuous | 20.8 Years STANDARD_DEVIATION 2.14 | 20.9 Years STANDARD_DEVIATION 2.1 | 20.6 Years STANDARD_DEVIATION 1.94 | 20.77 Years STANDARD_DEVIATION 2.06 |
| Race/Ethnicity, Customized African heritage/African American | 16 Participants | 13 Participants | 17 Participants | 46 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - East Asian heritage | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - Japanese heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian heritage | 258 Participants | 259 Participants | 257 Participants | 774 Participants |
| Race/Ethnicity, Customized Other | 100 Participants | 102 Participants | 100 Participants | 302 Participants |
| Race/Ethnicity, Customized White - Arabic/North African heritage | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian/European heritage | 13 Participants | 14 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Female | 197 Participants | 225 Participants | 204 Participants | 626 Participants |
| Sex: Female, Male Male | 193 Participants | 165 Participants | 186 Participants | 544 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 390 | 0 / 390 | 0 / 390 |
| other Total, other adverse events | 274 / 390 | 271 / 390 | 237 / 390 |
| serious Total, serious adverse events | 0 / 390 | 1 / 390 | 0 / 390 |
Outcome results
Primary
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Mencevax Group only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenA | 239 Participants |
| Nimenrix-A Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenC | 324 Participants |
| Nimenrix-A Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenW-135 | 328 Participants |
| Nimenrix-A Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenY | 334 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenY | 324 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenA | 238 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenW-135 | 312 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenC | 327 Participants |
| Mencevax Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenY | 308 Participants |
| Mencevax Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenC | 332 Participants |
| Mencevax Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenW-135 | 304 Participants |
| Mencevax Group | Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies | rSBA-MenA | 216 Participants |
Comparison: Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.95% CI: [-1.41, 12.25]
Comparison: Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.95% CI: [-4.11, 3.25]
Comparison: Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.95% CI: [3.28, 10.78]
Comparison: Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.95% CI: [2.63, 11.58]
Primary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Time frame: At Month 1
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Nimenrix-B Group only.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenA | 4846.0 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenC | 6025.4 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenW-135 | 9836.7 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenY | 11632.5 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenC | 7070.7 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenW-135 | 8855.5 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenA | 5064.6 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenY | 10386.7 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenW-135 | 4675.1 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenC | 5953.1 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenY | 6315.9 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenA | 3421.0 Titers |
Comparison: Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.95% CI: [0.92, 1.17]
Comparison: Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.95% CI: [0.96, 1.37]
Comparison: Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.95% CI: [0.8, 1.04]
Comparison: Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.95% CI: [0.78, 0.99]
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: Within 4-days (Days 0-3) post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 208 Participants |
| Nimenrix-A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 6 Participants |
| Nimenrix-A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 93 Participants |
| Nimenrix-A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 2 Participants |
| Nimenrix-A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 57 Participants |
| Nimenrix-A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 4 Participants |
| Nimenrix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Nimenrix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 210 Participants |
| Nimenrix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Nimenrix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 63 Participants |
| Nimenrix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 8 Participants |
| Nimenrix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 84 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 57 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 141 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 42 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature \[defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 4-days (Days 0-3) post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 117 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 113 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 50 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 2 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 44 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 105 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Relate Headache | 96 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 28 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Nimenrix-A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 27 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 20 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 110 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 119 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Relate Headache | 111 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 38 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 100 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 3 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 2 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 43 Participants |
| Nimenrix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 23 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 45 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 1 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 26 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 36 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 103 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 115 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Relate Headache | 95 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 109 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 24 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: Within 31-days (Days 0-30) post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix-A Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 103 Participants |
| Nimenrix-B Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 94 Participants |
| Mencevax Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 86 Participants |
Secondary
Number of Subjects With New Onset Chronic Illnesses (NOCI)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: Within 31-days (Days 0-30) post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix-A Group | Number of Subjects With New Onset Chronic Illnesses (NOCI) | 0 Participants |
| Nimenrix-B Group | Number of Subjects With New Onset Chronic Illnesses (NOCI) | 0 Participants |
| Mencevax Group | Number of Subjects With New Onset Chronic Illnesses (NOCI) | 0 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the GSK rSBA assay.
Time frame: At Day 0 and at Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenA, Day 0 | 296 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenA, Month 1 | 359 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenC, Day 0 | 211 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenC, Month 1 | 374 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenW- 135, Day 0 | 296 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenW- 135, Month 1 | 375 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenY, Day 0 | 335 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenY, Month 1 | 375 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenC, Day 0 | 213 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenY, Day 0 | 338 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenC, Month 1 | 370 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenW- 135, Day 0 | 286 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenW- 135, Month 1 | 370 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenA, Day 0 | 314 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenA, Month 1 | 343 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenY, Month 1 | 371 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenC, Day 0 | 224 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenA, Month 1 | 356 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenA, Day 0 | 295 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenC, Month 1 | 372 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenY, Day 0 | 336 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenW- 135, Month 1 | 372 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenW- 135, Day 0 | 298 Participants |
| Mencevax Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value | rSBA-MenY, Month 1 | 373 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Time frame: At Day 0 and Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Day 0 | 47 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Month 1 | 375 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Day 0 | 20 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Month 1 | 369 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Day 0 | 42 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Month 1 | 371 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Day 0 | 114 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Month 1 | 376 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Month 1 | 367 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Day 0 | 53 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Day 0 | 54 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Month 1 | 364 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Day 0 | 120 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Day 0 | 34 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Month 1 | 359 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Month 1 | 358 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Time frame: At Day 0 and at Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Day 0 | 66 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Month 1 | 376 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Day 0 | 44 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Month 1 | 371 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Day 0 | 69 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Month 1 | 371 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Day 0 | 140 Participants |
| Nimenrix-A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Month 1 | 376 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Month 1 | 367 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Day 0 | 77 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Day 0 | 76 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenA, Month 1 | 371 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenY, Day 0 | 136 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Day 0 | 57 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135, Month 1 | 362 Participants |
| Nimenrix-B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value | rSBA-MenC, Month 1 | 360 Participants |
Secondary
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Time frame: At Month 1
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix-A Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-Men | 356 Participants |
| Nimenrix-A Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 354 Participants |
| Nimenrix-A Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 356 Participants |
| Nimenrix-A Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 355 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 343 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-Men | 353 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 345 Participants |
| Nimenrix-B Group | Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 347 Participants |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs). The analysis was performed with the GSK rSBA assay.
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 348.4 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 36.3 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 185.9 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 387.5 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 426.8 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 401.4 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 191.2 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 44.7 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 412.6 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 46.9 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 205.5 Titers |
| Mencevax Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 424.4 Titers |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Time frame: At Day 0 and at Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, Day 0 | 4.7 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, Month 1 | 3463.4 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, Day 0 | 3.2 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, Month 1 | 4187.9 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, Day 0 | 4.8 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, Month 1 | 12725.1 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, Day 0 | 13.3 Titers |
| Nimenrix-A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, Month 1 | 5911.3 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, Month 1 | 2554.9 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, Day 0 | 5.3 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, Day 0 | 5.5 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, Month 1 | 2186.0 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, Day 0 | 12.6 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, Day 0 | 3.7 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, Month 1 | 4365.4 Titers |
| Nimenrix-B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, Month 1 | 3649.1 Titers |