Infections, Meningococcal
Conditions
Keywords
immunogenicity, safety, meningococcal vaccine
Brief summary
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Detailed description
Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One intramuscular dose
BIOLOGICALMencevax™ ACWY
One subcutaneous dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 17 years of age at the time of the vaccination. * Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two 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 first 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 first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine. * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y. * Previous vaccination with tetanus toxoid within the last month. * History of meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) 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 is demonstrated. * History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Response to Meningococcal Antigens | One month post-vaccination (At Month 1) | Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below (\<) 1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titer greater than or equal to (≥) 1:8\]. |
| Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms | During the 4-day (Days 0-3) period after vaccination | General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (\>) 39.5 degrees Celsius (°C). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | Prior to (Month 0) and one month after vaccination (Month 1) | The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (\>) 0.1 international units per milliliter (IU/mL). |
| Anti-TT Antibody Concentrations | Prior to (Month 0) and one month after vaccination (Month 1) | Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
| Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Prior to (Month 0) and one month after vaccination (Month 1) | The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. |
| Anti-meningococcal Polysaccharide Concentrations | Prior to (Month 0) and one month after vaccination (Month 1) | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). |
| Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | Prior to (Month 0) and one month after vaccination (Month 1) | Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) period after vaccination | Solicited general symptoms assessed included fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever \> 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events | During the 31-day (Days 0-30) post-vaccination period | 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 Any Serious Adverse Events (SAEs) | Up to study end (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. |
| Number of Subjects With Specific Adverse Events | Up to study end (Month 6) | These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) period after vaccination | Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm). |
| Meningococcal rSBA Antibody Titers | Prior to (Month 0) and one month after vaccination (Month 1) | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs). |
Countries
India, Philippines, Taiwan
Participant flow
Pre-assignment details
The target sample size was 1024 enrolled subjects, but a total of 1025 subjects (in all age strata) were actually enrolled and vaccinated in seven study centres in India, Taiwan and the Philippines.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm. | 768 |
| Mencevax ACWY Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm. | 257 |
| Total | 1,025 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Nimenrix Group | Mencevax ACWY Group | Total |
|---|---|---|---|
| Age, Continuous | 14.3 Years STANDARD_DEVIATION 1.97 | 14.3 Years STANDARD_DEVIATION 1.97 | 14.3 Years STANDARD_DEVIATION 1.97 |
| Race/Ethnicity, Customized Geographic ancestry Asian-Central/South Asian heritage | 296 Participants | 100 Participants | 396 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-East Asian heritage | 175 Participants | 59 Participants | 234 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-South East Asian heritage | 297 Participants | 98 Participants | 395 Participants |
| Sex: Female, Male Female | 414 Participants | 135 Participants | 549 Participants |
| Sex: Female, Male Male | 354 Participants | 122 Participants | 476 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 768 | 0 / 257 |
| other Total, other adverse events | 311 / 768 | 99 / 257 |
| serious Total, serious adverse events | 3 / 768 | 2 / 257 |
Outcome results
Primary
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms
General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (\>) 39.5 degrees Celsius (°C).
Time frame: During the 4-day (Days 0-3) period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms | 12 Participants |
| Mencevax ACWY Group | Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms | 1 Participants |
Comparison: To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.p-value: 0.145695% CI: [0.68, 24.6]Chi-squared
Primary
Number of Subjects With Vaccine Response to Meningococcal Antigens
Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below (\<) 1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titer greater than or equal to (≥) 1:8\].
Time frame: One month post-vaccination (At Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenA | 472 Participants |
| Nimenrix Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenC | 625 Participants |
| Nimenrix Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenW-135 | 616 Participants |
| Nimenrix Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenY | 616 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenY | 172 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenA | 148 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenW-135 | 189 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to Meningococcal Antigens | rSBA-MenC | 204 Participants |
Comparison: To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.95% CI: [1.63, 14.87]
Comparison: To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.95% CI: [-1.65, 4.18]
Comparison: To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.95% CI: [4.78, 14.14]
Comparison: To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.95% CI: [9.89, 21.37]
Secondary
Anti-meningococcal Polysaccharide Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSA, Month 0 | 1.05 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSA, Month 1 | 86.06 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSC, Month 0 | 0.21 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSC, Month 1 | 22.83 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSW-135, Month 0 | 0.18 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSW-135, Month 1 | 17.82 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSY, Month 0 | 0.2 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSY, Month 1 | 23.77 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSY, Month 1 | 17.97 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSA, Month 0 | 1.04 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSW-135, Month 0 | 0.18 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSA, Month 1 | 44.06 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSY, Month 0 | 0.22 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSC, Month 0 | 0.25 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSW-135, Month 1 | 13.22 μg/mL |
| Mencevax ACWY Group | Anti-meningococcal Polysaccharide Concentrations | Anti-PSC, Month 1 | 43.24 μg/mL |
Secondary
Anti-TT Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Anti-TT Antibody Concentrations | Anti-TT, Month 0 | 0.367 IU/mL |
| Nimenrix Group | Anti-TT Antibody Concentrations | Anti-TT, Month 1 | 10.305 IU/mL |
| Mencevax ACWY Group | Anti-TT Antibody Concentrations | Anti-TT, Month 0 | 0.41 IU/mL |
| Mencevax ACWY Group | Anti-TT Antibody Concentrations | Anti-TT, Month 1 | 0.459 IU/mL |
Secondary
Meningococcal rSBA Antibody Titers
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA-MenC, Month 1 | 13109.8 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA-MenA, Month 0 | 208.1 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA-MenA, Month 1 | 5928.5 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA-MenC, Month 0 | 44.1 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA- MenW-135, Month 0 | 109.4 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA- MenW-135, Month 1 | 8246.6 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA-MenY, Month 0 | 348.3 Titer |
| Nimenrix Group | Meningococcal rSBA Antibody Titers | rSBA-MenY, Month 1 | 14086.5 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA-MenY, Month 1 | 5066.3 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA- MenW-135, Month 0 | 112.2 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA-MenA, Month 0 | 155.9 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA-MenY, Month 0 | 299 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA-MenA, Month 1 | 2947.2 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA- MenW-135, Month 1 | 2632.7 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA-MenC, Month 0 | 40.9 Titer |
| Mencevax ACWY Group | Meningococcal rSBA Antibody Titers | rSBA-MenC, Month 1 | 8222 Titer |
Secondary
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values
The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 0.3 ug/mL, Month 0 | 235 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 0.3 ug/mL, Month 1 | 341 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 0.3 ug/mL, Month 0 | 50 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 0.3 ug/mL, Month 1 | 331 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 0.3 ug/mL, Month 0 | 40 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 0.3 ug/mL, Month 1 | 340 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 0.3 ug/mL, Month 0 | 49 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 0.3 ug/mL, Month 1 | 342 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 2 ug/mL, Month 0 | 130 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 2 ug/mL, Month 1 | 341 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 2 ug/mL, Month 0 | 17 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 2 ug/mL, Month 1 | 324 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 2 ug/mL, Month 0 | 9 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 2 ug/mL, Month 1 | 327 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 2 ug/mL, Month 0 | 12 Participants |
| Nimenrix Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 2 ug/mL, Month 1 | 336 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 2 ug/mL, Month 1 | 111 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 0.3 ug/mL, Month 0 | 75 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 2 ug/mL, Month 0 | 40 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 0.3 ug/mL, Month 1 | 107 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 2 ug/mL, Month 0 | 3 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 0.3 ug/mL, Month 0 | 21 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSA ≥ 2 ug/mL, Month 1 | 107 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 0.3 ug/mL, Month 1 | 107 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 2 ug/mL, Month 0 | 8 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 0.3 ug/mL, Month 0 | 8 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 2 ug/mL, Month 0 | 10 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 0.3 ug/mL, Month 1 | 113 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSW-135 ≥ 2 ug/mL, Month 1 | 106 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 0.3 ug/mL, Month 0 | 16 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSC ≥ 2 ug/mL, Month 1 | 106 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values | Anti-PSY ≥ 0.3 ug/mL, Month 1 | 113 Participants |
Secondary
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value
The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (\>) 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | Anti-TT, Month 0 | 439 Participants |
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | Anti-TT, Month 1 | 662 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | Anti-TT, Month 0 | 155 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value | Anti-TT, Month 1 | 157 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).
Time frame: During the 4-day (Days 0-3) period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 200 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 6 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 94 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 2 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 71 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 9 Participants |
| Mencevax ACWY Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 16 Participants |
| Mencevax ACWY Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 68 Participants |
| Mencevax ACWY Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Mencevax ACWY Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Mencevax ACWY Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Mencevax ACWY Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 16 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed included fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever \> 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 4-day (Days 0-3) period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 109 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 7 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 83 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) | 55 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 3 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 42 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 35 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 24 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 102 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 5 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 81 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 36 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 11 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 27 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 26 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 1 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) | 13 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 19 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 9 Participants |
| Mencevax ACWY Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 10 Participants |
Secondary
Number of Subjects With Any 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: Up to study end (Month 6)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 3 Participants |
| Mencevax ACWY Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events
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) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any Unsolicited Adverse Events | 72 Participants |
| Mencevax ACWY Group | Number of Subjects With Any Unsolicited Adverse Events | 26 Participants |
Secondary
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values
Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: Prior to (Month 0) and one month after vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures and assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 0 ≥ 1:8 | 463 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 0 ≥ 1:128 | 427 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 1 ≥ 1:8 | 674 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 1 ≥ 1:128 | 674 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 0 ≥ 1:8 | 381 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 0 ≥ 1:128 | 277 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 1 ≥ 1:8 | 673 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 1 ≥ 1:128 | 672 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 0 ≥ 1:8 | 519 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 0 ≥ 1:128 | 373 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 1 ≥ 1:8 | 677 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 1 ≥ 1:128 | 677 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 0 ≥ 1:8 | 597 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 0 ≥ 1:128 | 538 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 1 ≥ 1:8 | 677 Participants |
| Nimenrix Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 1 ≥ 1:128 | 677 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 1 ≥ 1:128 | 224 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 0 ≥ 1:8 | 148 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 0 ≥ 1:8 | 176 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 0 ≥ 1:128 | 128 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 0 ≥ 1:8 | 186 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 1 ≥ 1:8 | 223 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 0 ≥ 1:128 | 120 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenA, Month 1 ≥ 1:128 | 223 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 1 ≥ 1:8 | 224 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 0 ≥ 1:8 | 121 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 1 ≥ 1:8 | 224 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 0 ≥ 1:128 | 79 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenY, Month 0 ≥ 1:128 | 167 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 1 ≥ 1:8 | 224 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA- MenW-135, Month 1 ≥ 1:128 | 223 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values | rSBA-MenC, Month 1 ≥ 1:128 | 223 Participants |
Secondary
Number of Subjects With Specific Adverse Events
These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).
Time frame: Up to study end (Month 6)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Specific Adverse Events | Any Rash | 6 Participants |
| Nimenrix Group | Number of Subjects With Specific Adverse Events | Any NOCIs | 0 Participants |
| Nimenrix Group | Number of Subjects With Specific Adverse Events | Any ER visits | 1 Participants |
| Mencevax ACWY Group | Number of Subjects With Specific Adverse Events | Any Rash | 1 Participants |
| Mencevax ACWY Group | Number of Subjects With Specific Adverse Events | Any NOCIs | 0 Participants |
| Mencevax ACWY Group | Number of Subjects With Specific Adverse Events | Any ER visits | 0 Participants |