Infections, Meningococcal
Conditions
Keywords
Neisseria meningitidis, Adult, Adolescent, Safety, Vaccines, conjugate, Meningococcal vaccines, Immunogenicity
Brief summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.
Interventions
BIOLOGICALMeningococcal vaccine GSK 134612
One intramuscular injection
BIOLOGICALMenactra®
One intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 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 that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * A male or female between, and including, 10 and 25 years of age at the time of the vaccination. * Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge. * 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 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 (defined as more than 14 days) 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. * Previous vaccination with meningococcal polysaccharide or conjugate vaccine. * Previous vaccination with vaccine components within the last month. * History of meningococcal disease. * 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 is demonstrated. * History of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex. * History of any neurologic disorders, including Guillain-Barré Syndrome. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrollment. * 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. * Child in care. * 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 to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | One month after vaccination (Month 1) | Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | Prior to (PRE) and one month after vaccination (Month 1) | Antibody titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | One month after vaccination (Month 1) | Vaccine response was defined as: -for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | Prior to (PRE) and one month after vaccination (Month 1) | The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31 days (Day 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 of Chronic Illness(es) (NOCI) | From Month 0 through Month 6 | NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | From Month 0 through Month 6 | 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, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Out of the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix Lot A Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 337 |
| Nimenrix Lot B Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 336 |
| Menactra Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 338 |
| Total | 1,011 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Extended Holiday | 0 | 0 | 1 |
| Overall Study | Incarcerated Subjects | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 9 | 7 | 10 |
| Overall Study | Unreachable Subjects | 1 | 0 | 0 |
| Overall Study | Visit 2 Declined by Subject | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Nimenrix Lot A Group | Nimenrix Lot B Group | Menactra Group | Total |
|---|---|---|---|---|
| Age, Continuous | 16.4 Years STANDARD_DEVIATION 5.16 | 16.3 Years STANDARD_DEVIATION 5.16 | 16.2 Years STANDARD_DEVIATION 4.97 | 16.30 Years STANDARD_DEVIATION 5.09 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage/ African American | 38 Participants | 29 Participants | 40 Participants | 107 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan Native | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-Central/ South Asian Heritage | 17 Participants | 17 Participants | 17 Participants | 51 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian Heritage | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese Heritage | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian Heritage | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other (Mix of races, e.g. African/White) | 20 Participants | 28 Participants | 14 Participants | 62 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/ North African Heritage | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/ European Heritage | 248 Participants | 249 Participants | 257 Participants | 754 Participants |
| Sex: Female, Male Female | 175 Participants | 169 Participants | 176 Participants | 520 Participants |
| Sex: Female, Male Male | 162 Participants | 167 Participants | 162 Participants | 491 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 337 | 0 / 336 | 0 / 338 |
| other Total, other adverse events | 232 / 337 | 219 / 336 | 234 / 338 |
| serious Total, serious adverse events | 1 / 337 | 5 / 336 | 2 / 338 |
Outcome results
Primary
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Time frame: 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 who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenA | 218 Participants |
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenC | 217 Participants |
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenW-135 | 198 Participants |
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenY | 150 Participants |
| Menactra Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenY | 115 Participants |
| Menactra Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenA | 191 Participants |
| Menactra Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenW-135 | 185 Participants |
| Menactra Group | Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies | hSBA-MenC | 209 Participants |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC, PRE | 15.6 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA, PRE | 3.6 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC, Month 1 | 687.1 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY, Month 1 | 349.1 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA, Month 1 | 54.2 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135, PRE | 7.7 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY, PRE | 45.7 Titers |
| Nimenrix Lot A Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135, Month 1 | 174.5 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA, Month 1 | 49.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135, Month 1 | 161.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA, PRE | 3.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY, PRE | 49.8 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY, Month 1 | 387.4 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC, PRE | 16.0 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC, Month 1 | 755.8 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135, PRE | 7.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC, Month 1 | 543.3 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA, PRE | 3.6 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA, Month 1 | 41.3 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC, PRE | 18.0 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY, Month 1 | 253.8 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135, PRE | 7.4 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135, Month 1 | 101.7 Titers |
| Menactra Group | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY, PRE | 55.3 Titers |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 63 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 85 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 169 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 3 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 8 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 2 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 5 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 40 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 167 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 60 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 180 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 66 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 6 Participants |
| Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 44 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 9 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 4 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 43 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (Orally) | 1 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 31 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 96 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (Orally) | 17 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 86 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature (Orally) | 15 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 75 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 5 Participants |
| Nimenrix Lot A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 72 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 70 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (Orally) | 14 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (Orally) | 0 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 43 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature (Orally) | 10 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 3 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 7 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 33 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 94 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 87 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 80 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 32 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 89 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 5 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 77 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 44 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 4 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature (Orally) | 12 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 83 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 6 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 68 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature (Orally) | 16 Participants |
| Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature (Orally) | 0 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 through Month 6
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 1 Participants |
| Menactra Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 5 Participants |
| Menactra Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 2 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 (Day 0-30) post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 105 Participants |
| Menactra Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 76 Participants |
| Menactra Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 85 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE) and one month after vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, PRE | 175 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, Month 1 | 295 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, PRE | 79 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, Month 1 | 253 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, PRE | 99 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, Month 1 | 272 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, PRE | 215 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, Month 1 | 307 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, PRE | 224 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, Month 1 | 293 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, PRE | 98 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, Month 1 | 262 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, PRE | 188 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, Month 1 | 302 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, PRE | 84 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, Month 1 | 243 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, Month 1 | 247 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, Month 1 | 223 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, PRE | 89 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, Month 1 | 291 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, PRE | 234 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, PRE | 197 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, PRE | 102 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, Month 1 | 287 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value
The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.
Time frame: Prior to (PRE) and one month after vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, PRE | 174 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, Month 1 | 307 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, PRE | 99 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, Month 1 | 295 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, PRE | 215 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, Month 1 | 251 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, PRE | 61 Participants |
| Nimenrix Lot A Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, Month 1 | 272 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, Month 1 | 292 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, PRE | 65 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, Month 1 | 242 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, PRE | 185 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, Month 1 | 302 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, PRE | 97 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, Month 1 | 262 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, PRE | 223 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, PRE | 101 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, Month 1 | 221 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, PRE | 234 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135, Month 1 | 247 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenA, PRE | 67 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, Month 1 | 291 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenC, PRE | 193 Participants |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value | hSBA-MenY, Month 1 | 287 Participants |
Secondary
Number of Subjects With New Onset of Chronic Illness(es) (NOCI)
NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.
Time frame: From Month 0 through Month 6
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With New Onset of Chronic Illness(es) (NOCI) | 3 Participants |
| Menactra Group | Number of Subjects With New Onset of Chronic Illness(es) (NOCI) | 0 Participants |
| Menactra Group | Number of Subjects With New Onset of Chronic Illness(es) (NOCI) | 0 Participants |
Secondary
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as: -for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Time frame: One month after vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA | 214 Participants |
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC | 226 Participants |
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 | 196 Participants |
| Nimenrix Lot A Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY | 150 Participants |