Infections, Meningococcal
Conditions
Keywords
Booster vaccination, Meningococcal vaccine, Meningococcal disease, Safety, immunogenicity
Brief summary
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology. These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
Detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups. This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.
Interventions
one dose, as intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394. * For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination. * Written informed 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 his/her 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 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up). * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine. * Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * For the MPS Group, vaccination against meningococcal disease after completion of study 102394 * For the noMPS group, previous vaccination, or vaccination within the last 10 years, against meningococcal disease (of any serogroup). * Previous vaccination against tetanus within 30 days. * History of meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical. * A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function. * History of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * Know hypersensitivity to any component of the vaccine. * Major congenital defects or serious chronic illness. * History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. * Acute disease at the time of enrolment * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active stage of the study period. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | One month post-vaccination (Month 1) | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Prior to (Day 0) and one month post-vaccination (Month 1) | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs). |
| Anti-tetanus Toxoid Antibody Concentrations | Prior to (Day 0) and one month post-vaccination (Month 1) | Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs). |
| Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | One month post-vaccination (Month 1) | Vaccine response defined as: For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0 to Day 3) period after 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 100 millimeters (mm) of injection site. |
| Meningococcal rSBA Titers | Prior to vaccination (Day 0) | For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs). |
| Number of Subjects With Unsolicited Symptoms | Up to one month post-vaccination (Month 1) | An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Any Serious Adverse Events | Day 0 to study 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 Any Specific Adverse Events | Day 0 to study month 6 | Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease). Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0 to Day 3) period after vaccination | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
Countries
Lebanon
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mencevax Primed Group Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. | 192 |
| Mencevax Naive Group Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm. | 79 |
| Total | 271 |
Baseline characteristics
| Characteristic | Mencevax Naive Group | Total | Mencevax Primed Group |
|---|---|---|---|
| Age, Continuous | 14.2 Years STANDARD_DEVIATION 7.23 | 14.13 Years STANDARD_DEVIATION 6.91 | 14.1 Years STANDARD_DEVIATION 6.79 |
| Race/Ethnicity, Customized White - Arabic/North African heritage | 77 Participants | 269 Participants | 192 Participants |
| Race/Ethnicity, Customized White - Caucasian/European heritage | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Female | 41 Participants | 132 Participants | 91 Participants |
| Sex: Female, Male Male | 38 Participants | 139 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 192 | 0 / 79 |
| other Total, other adverse events | 111 / 192 | 42 / 79 |
| serious Total, serious adverse events | 1 / 192 | 0 / 79 |
Outcome results
Primary
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Time frame: One month post-vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mencevax Primed Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenA | 6868.8 Titers |
| Mencevax Primed Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenC | 1945.8 Titers |
| Mencevax Primed Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenW-135 | 4635.7 Titers |
| Mencevax Primed Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenY | 7799.9 Titers |
| Mencevax Naive Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenY | 13895.5 Titers |
| Mencevax Naive Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenA | 13014.9 Titers |
| Mencevax Naive Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenW-135 | 9078.0 Titers |
| Mencevax Naive Group | Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers | rSBA-MenC | 5494.6 Titers |
Secondary
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs).
Time frame: Prior to (Day 0) and one month post-vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSA, Day 0 | 9.38 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSA, Month 1 | 79.15 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSC, Day 0 | 6.46 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSC, Month 1 | 31.19 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSW-135, Day 0 | 3.40 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSW-135, Month 1 | 25.10 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSY, Day 0 | 4.05 µg/mL |
| Mencevax Primed Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSY, Month 1 | 29.98 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSY, Month 1 | 17.58 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSA, Day 0 | 0.41 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSW-135, Day 0 | 0.20 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSA, Month 1 | 47.45 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSY, Day 0 | 0.21 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSC, Day 0 | 0.31 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSW-135, Month 1 | 14.67 µg/mL |
| Mencevax Naive Group | Anti-meningococcal Polysaccharide (PS) Antibody Concentrations | Anti-PSC, Month 1 | 18.81 µg/mL |
Secondary
Anti-tetanus Toxoid Antibody Concentrations
Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs).
Time frame: Prior to (Day 0) and one month post-vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mencevax Primed Group | Anti-tetanus Toxoid Antibody Concentrations | Pre-vaccination | 0.718 IU/mL |
| Mencevax Primed Group | Anti-tetanus Toxoid Antibody Concentrations | Post-vaccination | 17.678 IU/mL |
| Mencevax Naive Group | Anti-tetanus Toxoid Antibody Concentrations | Post-vaccination | 41.600 IU/mL |
| Mencevax Naive Group | Anti-tetanus Toxoid Antibody Concentrations | Pre-vaccination | 1.515 IU/mL |
Secondary
Meningococcal rSBA Titers
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Time frame: Prior to vaccination (Day 0)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mencevax Primed Group | Meningococcal rSBA Titers | rSBA-MenA | 1770.1 Titers |
| Mencevax Primed Group | Meningococcal rSBA Titers | rSBA-MenC | 116.6 Titers |
| Mencevax Primed Group | Meningococcal rSBA Titers | rSBA-MenW-135 | 154.0 Titers |
| Mencevax Primed Group | Meningococcal rSBA Titers | rSBA-MenY | 555.2 Titers |
| Mencevax Naive Group | Meningococcal rSBA Titers | rSBA-MenY | 170.1 Titers |
| Mencevax Naive Group | Meningococcal rSBA Titers | rSBA-MenA | 1103.8 Titers |
| Mencevax Naive Group | Meningococcal rSBA Titers | rSBA-MenW-135 | 36.9 Titers |
| Mencevax Naive Group | Meningococcal rSBA Titers | rSBA-MenC | 30.1 Titers |
Secondary
Number of Subjects Reporting Any Serious Adverse Events
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: Day 0 to study month 6
Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mencevax Primed Group | Number of Subjects Reporting Any Serious Adverse Events | 1 Participants |
| Mencevax Naive Group | Number of Subjects Reporting Any Serious Adverse Events | 0 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 100 millimeters (mm) of injection site.
Time frame: During the 4-day (Day 0 to Day 3) period after vaccination
Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 84 Participants |
| Mencevax Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 8 Participants |
| Mencevax Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 35 Participants |
| Mencevax Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 3 Participants |
| Mencevax Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 40 Participants |
| Mencevax Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 9 Participants |
| Mencevax Naive Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 20 Participants |
| Mencevax Naive Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 27 Participants |
| Mencevax Naive Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 1 Participants |
| Mencevax Naive Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Mencevax Naive Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 2 Participants |
| Mencevax Naive Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 17 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Day 0 to Day 3) period after vaccination
Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (oral temperature) | 31 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 59 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 9 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 54 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (oral temperature) | 33 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (oral temperature) | 2 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Symptoms | 26 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal Symptoms | 4 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal Symptoms | 24 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 52 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 5 Participants |
| Mencevax Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 45 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Symptoms | 10 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 15 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 17 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal Symptoms | 0 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 9 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 9 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (oral temperature) | 15 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal Symptoms | 6 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (oral temperature) | 0 Participants |
| Mencevax Naive Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (oral temperature) | 6 Participants |
Secondary
Number of Subjects With Any Specific Adverse Events
Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease). Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately.
Time frame: Day 0 to study month 6
Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax Primed Group | Number of Subjects With Any Specific Adverse Events | Subjects with any rash | 0 Participants |
| Mencevax Primed Group | Number of Subjects With Any Specific Adverse Events | Subjects with any NOCI(s) | 0 Participants |
| Mencevax Primed Group | Number of Subjects With Any Specific Adverse Events | Subjects with any ER visit(s) | 0 Participants |
| Mencevax Naive Group | Number of Subjects With Any Specific Adverse Events | Subjects with any rash | 0 Participants |
| Mencevax Naive Group | Number of Subjects With Any Specific Adverse Events | Subjects with any NOCI(s) | 2 Participants |
| Mencevax Naive Group | Number of Subjects With Any Specific Adverse Events | Subjects with any ER visit(s) | 1 Participants |
Secondary
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
Vaccine response defined as: For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer
Time frame: One month post-vaccination (Month 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax Primed Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenA | 58 Participants |
| Mencevax Primed Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenC | 110 Participants |
| Mencevax Primed Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenW-135 | 137 Participants |
| Mencevax Primed Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenY | 125 Participants |
| Mencevax Naive Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenY | 71 Participants |
| Mencevax Naive Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenA | 50 Participants |
| Mencevax Naive Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenW-135 | 72 Participants |
| Mencevax Naive Group | Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y | rSBA-MenC | 68 Participants |
Secondary
Number of Subjects With Unsolicited Symptoms
An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination.
Time frame: Up to one month post-vaccination (Month 1)
Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mencevax Primed Group | Number of Subjects With Unsolicited Symptoms | 19 Participants |
| Mencevax Naive Group | Number of Subjects With Unsolicited Symptoms | 11 Participants |