Infections, Meningococcal, Meningococcal Vaccines
Conditions
Keywords
Immunogenicity, Persistence, Safety, Conjugate vaccine, Meningococcal vaccine
Brief summary
The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®. This protocol posting deals with objectives & outcome measures of the persistence and booster epochs. The objectives & outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)
Detailed description
Subjects were previously vaccinated at 2 to 10 years of age with GSK134612 or with Menjugate®. The persistence phase starts 32 months after the primary vaccination and blood samples will be taken at 32, 44, 56 and 68 months after primary vaccination. All subjects will receive a booster dose of GSK134612 at 68 months after primary vaccination and a blood sample will be taken 1 month after administration of the booster dose.
Interventions
BIOLOGICALNimenrix (GSK134612 vaccine)
Intramuscular, 1 dose
BIOLOGICALMenjugate
Intramuscular, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study (NCT number = NCT00674583). * Written informed consent obtained from the parent(s)/Legally Acceptable Representatives(s) of the subject and written informed assent obtained from the subject (at investigator discretion). * Healthy subjects as established by medical history and clinical examination before entering into the study. All subjects must meet the additional following criteria prior to receiving the booster vaccination: * Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product within 30 days preceding the first persistence blood sample or planned use within 30 days preceding a blood sample during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, prednisone \<10 mg/day, or equivalent, inhaled and topical steroids are allowed). * Concurrently participating in another clinical study or planned participation in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational product within 30 days of a blood sample. * History of meningococcal disease. * Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the previous vaccination in the primary vaccination study (NCT number = NCT00674583). * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination. * Serious chronic illness. * Administration of immunoglobulins and/or blood products within the 3 months preceding the subject's first visit. * Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. * Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135. * Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | At Month 32, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | At Month 44, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | At Month 56, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | At Month 68, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | At Month 32, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | At Month 44, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | At Month 56, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | At Month 68, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | At Month 32, post-primary vaccination | The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | At Month 44, post-primary vaccination | The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | At Month 56, post-primary vaccination | The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | At Month 68, post-primary vaccination | The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed in all subjects, by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | At Month 32, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | At Month 44, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | At Month 56, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | At Month 68, post-primary vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | At Month 32, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | At Month 69, one month post-booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | At Month 69, one month post-booster vaccination | The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | At Month 69, one month post-booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | At Month 69, one month post-booster vaccination | Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \<1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥1:8). |
| Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | At Month 69, one month post-booster vaccination | Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY was defined as hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titers \<1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titers ≥1:4). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) period following the booster vaccination | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 50 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity. |
| Number of Subjects With Any, Grade 3 and Solicited General Symptoms | During the 4-day (Days 0-3) period following the booster vaccination | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = Fatigue that prevented normal activity. Grade 3 Gastrointestinal symptoms = Gastrointestinal symptoms that prevented normal everyday activities. Grade 3 Headache = Headache that prevented normal acitivity. Grade 3 Fever = Rectal temperature higher than (\>) 39.5°C. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) period following the booster 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 Serious Adverse Events (SAEs) | During the 31-day (Days 0-30) period following the booster vaccination | 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 New Onset of Chronic Illnesses (NOCIs) | During the 31-day (Days 0-30) period following the booster vaccination | New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies. |
| Number of Subjects With Serious Adverse Events SAEs | Up to Month 32, 44, 56 and 68 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | At Month 69, one month post-booster vaccination | The pre-defined cut-off values of the assay for the rSBA titers were greater than or equal to (≥) 1:128 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | At Month 44, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | At Month 56, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | At Month 68, post-primary vaccination | The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory. |
Countries
France, Germany
Participant flow
Recruitment details
Out of 282 subjects participating to the study, 271 participated to Month 32-44 period, 261 to Month 44-56, 260 to Month 56-68, and 282 to Month 68-69 booster period. Out of 282 subjects participating to Month 68-69 booster period, 41 subjects had a subject number allocated but received no vaccine dose, hence only 241 started this phase.
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. | 199 |
| Menjugate Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. | 72 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Booster Phase (Month 68-69) | Lost to Follow-up | 5 | 1 |
| Booster Phase (Month 68-69) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Menjugate Group | Total | Nimenrix Group |
|---|---|---|---|
| Age, Continuous | 8.1 Years STANDARD_DEVIATION 2.42 | 8.32 Years STANDARD_DEVIATION 2.54 | 8.4 Years STANDARD_DEVIATION 2.58 |
| Race/Ethnicity, Customized Geographic ancestry African heritage / African American | 2 Participants | 9 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian heritage | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese heritage | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or other pacific islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 2 Participants | 10 Participants | 8 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic / North African heritage | 6 Participants | 18 Participants | 12 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European Heritage | 61 Participants | 230 Participants | 169 Participants |
| Sex: Female, Male Female | 34 Participants | 137 Participants | 103 Participants |
| Sex: Female, Male Male | 38 Participants | 134 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 179 | 0 / 62 |
| other Total, other adverse events | 130 / 179 | 48 / 62 |
| serious Total, serious adverse events | 0 / 179 | 0 / 62 |
Outcome results
Primary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 44, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenA | 162 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenC | 70 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenW-135 | 129 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenY | 118 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenY | 4 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenA | 17 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenW-135 | 7 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. | rSBA-MenC | 30 Participants |
Primary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 56, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenA | 161 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenC | 110 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenW-135 | 145 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenY | 149 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenY | 14 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenA | 19 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenW-135 | 17 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. | rSBA-MenC | 42 Participants |
Primary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 68, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenA | 154 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenC | 71 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenW-135 | 94 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenY | 127 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenY | 8 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenA | 18 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenW-135 | 9 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. | rSBA-MenC | 38 Participants |
Primary
Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 32, post-primary vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenA | 167 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenC | 124 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenW-135 | 149 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenY | 157 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenY | 10 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenA | 15 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenW-135 | 5 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. | rSBA-MenC | 53 Participants |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 69, one month post-booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenA | 1376.5 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenC | 11986.8 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenW-135 | 14582.1 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenY | 12835.9 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenY | 527.3 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenA | 101.2 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenW-135 | 235.7 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | hSBA-MenC | 13692.2 Titers |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 32, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenA | 4.6 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenC | 75.9 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenW-135 | 69.9 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenY | 79.2 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenY | 15.1 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenA | 2.7 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenW-135 | 3.8 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. | hSBA-MenC | 82.2 Titers |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 44, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenA | 4.8 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenC | 36.4 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenW-135 | 64.3 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenY | 126.7 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenY | 16.8 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenA | 2.8 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenW-135 | 5.2 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. | hSBA-MenC | 38.8 Titers |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 56, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenA | 10.6 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenC | 20.6 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenW-135 | 59.3 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenY | 117.9 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenY | 35.7 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenA | 7.6 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenW-135 | 9.2 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. | hSBA-MenC | 31.2 Titers |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 68, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenA | 6.9 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenC | 28.4 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenW-135 | 56.7 Titers |
| Nimenrix Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenY | 56.3 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenY | 13.3 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenA | 4.5 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenW-135 | 8.1 Titers |
| Menjugate Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. | hSBA-MenC | 34.3 Titers |
Secondary
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 69, one month post-booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenA | 5613.0 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenC | 5314.6 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenW-135 | 14750.6 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenY | 7954.6 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenY | 5829.2 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenA | 3521.1 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenW-135 | 10540.4 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenC | 7042.2 Titers |
Secondary
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 32, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenA | 196.3 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenC | 34.8 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenW-135 | 213.9 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenY | 227.4 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenY | 7.2 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenA | 8 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenW-135 | 5.6 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. | rSBA-MenC | 86.5 Titers |
Secondary
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 44, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenA | 307.5 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenC | 14.5 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenW-135 | 103.5 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenY | 78.9 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenY | 4.9 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenA | 13.5 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenW-135 | 5.9 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. | rSBA-MenC | 31 Titers |
Secondary
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 56, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenA | 120.1 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenC | 30.5 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenW-135 | 158.3 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenY | 233.2 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenY | 9.0 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenA | 9.8 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenW-135 | 10.3 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. | rSBA-MenC | 69.0 Titers |
Secondary
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68.
Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 68, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenA | 129.5 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenC | 14.2 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenW-135 | 59.2 Titers |
| Nimenrix Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenY | 139.4 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenY | 6.8 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenA | 11.1 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenW-135 | 7.8 Titers |
| Menjugate Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. | rSBA-MenC | 44.5 Titers |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 50 millimeters (mm). Any was defined as incidence of the specified symptom regardless of intensity.
Time frame: During the 4-day (Days 0-3) period following the booster vaccination
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 8 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 7 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 52 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 62 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 4 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 113 Participants |
| Menjugate Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Menjugate Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 35 Participants |
| Menjugate Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 25 Participants |
| Menjugate Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 4 Participants |
| Menjugate Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 19 Participants |
| Menjugate Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 4 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature (axillary temperature higher than \[≥\] 37.5 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = Fatigue that prevented normal activity. Grade 3 Gastrointestinal symptoms = Gastrointestinal symptoms that prevented normal everyday activities. Grade 3 Headache = Headache that prevented normal acitivity. Grade 3 Fever = Rectal temperature higher than (\>) 39.5°C.
Time frame: During the 4-day (Days 0-3) period following the booster vaccination
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 2 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Gastrointestinal symptoms | 10 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Headache | 43 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Headache | 7 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Headache | 27 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Temperature | 11 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Temperature | 9 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Fatigue | 38 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Fatigue | 28 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Gastrointestinal symptoms | 19 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Fatigue | 10 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 1 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Gastrointestinal symptoms | 3 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Headache | 10 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Temperature | 3 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Gastrointestinal symptoms | 7 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Related Headache | 8 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Fatigue | 12 Participants |
| Menjugate Group | Number of Subjects With Any, Grade 3 and Solicited General Symptoms | Any Temperature | 5 Participants |
Secondary
Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies.
Time frame: During the 31-day (Days 0-30) period following the booster vaccination
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
| Menjugate Group | Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) period following the booster vaccination
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 26 Participants |
| Menjugate Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 8 Participants |
Secondary
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY was defined as hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA antibody titers \<1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination hSBA antibody titers ≥1:4).
Time frame: At Month 69, one month post-booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA | 156 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC | 153 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 | 136 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY | 142 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY | 35 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA | 43 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 | 34 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC | 46 Participants |
Secondary
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as rSBA antibody titers ≥1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \<1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥1:8).
Time frame: At Month 69, one month post-booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 147 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 161 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 157 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 156 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 54 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 54 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 54 Participants |
| Menjugate Group | Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 48 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 69, one month post-booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenA, ≥ 1:4 | 163 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenC, ≥ 1:4 | 161 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenW-135, ≥ 1:4 | 156 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenY, ≥ 1:4 | 160 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenA, ≥ 1:8 | 163 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenC, ≥ 1:8 | 161 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenW-135, ≥ 1:8 | 156 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenY, ≥ 1:8 | 160 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenY, ≥ 1:8 | 52 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenA, ≥ 1:4 | 46 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenA, ≥ 1:8 | 46 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenC, ≥ 1:4 | 54 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenW-135, ≥ 1:8 | 50 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenW-135, ≥ 1:4 | 50 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenC, ≥ 1:8 | 54 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. | hSBA-MenY, ≥ 1:4 | 52 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 44, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenA, ≥ 1:4 | 26 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenC, ≥ 1:4 | 63 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenW-135, ≥ 1:4 | 70 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenY, ≥ 1:4 | 63 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenA, ≥ 1:8 | 23 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenC, ≥ 1:8 | 63 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenW-135, ≥ 1:8 | 70 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenY, ≥ 1:8 | 63 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenY, ≥ 1:8 | 12 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenA, ≥ 1:4 | 5 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenA, ≥ 1:8 | 5 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenC, ≥ 1:4 | 20 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenW-135, ≥ 1:8 | 8 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenW-135, ≥ 1:4 | 8 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenC, ≥ 1:8 | 20 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. | hSBA-MenY, ≥ 1:4 | 12 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 56, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenA, ≥ 1:4 | 53 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenC, ≥ 1:4 | 66 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenW-135, ≥ 1:4 | 69 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenY, ≥ 1:4 | 79 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenA, ≥ 1:8 | 53 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenC, ≥ 1:8 | 64 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenW-135, ≥ 1:8 | 69 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenY, ≥ 1:8 | 79 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenY, ≥ 1:8 | 22 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenA, ≥ 1:4 | 19 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenA, ≥ 1:8 | 19 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenC, ≥ 1:4 | 21 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenW-135, ≥ 1:8 | 13 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenW-135, ≥ 1:4 | 13 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenC, ≥ 1:8 | 21 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. | hSBA-MenY, ≥ 1:4 | 22 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed in all subjects, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 68, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenA, ≥ 1:4 | 70 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenC, ≥ 1:4 | 134 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenW-135, ≥ 1:4 | 125 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenY, ≥ 1:4 | 116 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenA, ≥ 1:8 | 69 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenC, ≥ 1:8 | 130 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenW-135, ≥ 1:8 | 125 Participants |
| Nimenrix Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenY, ≥ 1:8 | 116 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenY, ≥ 1:8 | 24 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenA, ≥ 1:4 | 23 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenA, ≥ 1:8 | 21 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenC, ≥ 1:4 | 43 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenW-135, ≥ 1:8 | 19 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenW-135, ≥ 1:4 | 19 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenC, ≥ 1:8 | 43 Participants |
| Menjugate Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. | hSBA-MenY, ≥ 1:4 | 24 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8.
The pre-defined cut-off values of the assay for the rSBA titers were greater than or equal to (≥) 1:128 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 69, one month post-booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenA, ≥ 1:8 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenC, ≥ 1:8 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenW-135, ≥ 1:8 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenY, ≥ 1:8 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenA, ≥ 1:128 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenC, ≥ 1:128 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenW-135, ≥ 1:128 | 165 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenY, ≥ 1:128 | 165 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenY, ≥ 1:128 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenA, ≥ 1:8 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenA, ≥ 1:128 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenC, ≥ 1:8 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenW-135, ≥ 1:128 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenW-135, ≥ 1:8 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenC, ≥ 1:128 | 55 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. | rSBA-MenY, ≥ 1:8 | 55 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 32, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenA | 140 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenC | 69 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenW-135 | 136 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenY | 145 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenY | 8 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenA | 9 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenW-135 | 5 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. | rSBA-MenC | 35 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 44, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenA | 151 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenC | 38 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenW-135 | 120 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenY | 107 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenY | 3 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenA | 16 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenW-135 | 5 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. | rSBA-MenC | 23 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 56, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenA | 107 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenC | 65 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenW-135 | 123 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenY | 139 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenY | 10 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenA | 10 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenW-135 | 10 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. | rSBA-MenC | 32 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 68, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenA | 107 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenC | 38 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenW-135 | 84 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenY | 118 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenY | 6 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenA | 12 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenW-135 | 8 Participants |
| Menjugate Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. | rSBA-MenC | 25 Participants |
Secondary
Number of Subjects With Serious Adverse Events SAEs
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.
Time frame: Up to Month 32, 44, 56 and 68
Population: The analysis was performed on the Total Vaccinated cohort at Months 32, 44, 56 annd 68, which included all vaccinated subjects in the primary 111414 study (NCT00674583) who came back for persistence visit at Months 32, 44, 56 and 68, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 32 | 0 Participants |
| Nimenrix Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 44 | 0 Participants |
| Nimenrix Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 56 | 0 Participants |
| Nimenrix Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 68 | 0 Participants |
| Menjugate Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 68 | 0 Participants |
| Menjugate Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 32 | 0 Participants |
| Menjugate Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 56 | 0 Participants |
| Menjugate Group | Number of Subjects With Serious Adverse Events SAEs | Up to Month 44 | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the 31-day (Days 0-30) period following the booster vaccination
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32.
The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.
Time frame: At Month 32, post-primary vaccination
Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenA, ≥ 1:4 | 24 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenC, ≥ 1:4 | 86 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenW-135, ≥ 1:4 | 73 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenY, ≥ 1:4 | 74 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenA, ≥ 1:8 | 23 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenC, ≥ 1:8 | 86 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenW-135, ≥ 1:8 | 73 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenY, ≥ 1:8 | 74 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenY, ≥ 1:8 | 13 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenA, ≥ 1:4 | 5 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenA, ≥ 1:8 | 5 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenC, ≥ 1:4 | 30 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenW-135, ≥ 1:8 | 4 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenW-135, ≥ 1:4 | 4 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenC, ≥ 1:8 | 30 Participants |
| Menjugate Group | Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. | hSBA-MenY, ≥ 1:4 | 13 Participants |