Infections, Meningococcal
Conditions
Keywords
Healthy, Immunogenicity, Children, Neisseria meningitidis, Long-term antibody persistence, Safety, Serogroups A, C, W-135, and Y
Brief summary
The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.
Detailed description
The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.
Interventions
PROCEDUREBlood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: * Child in care. * History of meningococcal disease. * Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | 24 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | 36 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | 48 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | 60 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | 72 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | 24, 36, 48, 60 and 72 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | 24, 36, 48, 60 and 72 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | Baseline up to the Month 72 after booster vaccination (up to 6 years) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | 24, 36, 48, 60 and 72 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | 24, 36, 48, 60 and 72 months after booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
Countries
Finland
Participant flow
Pre-assignment details
In this study, participants from the study MENACWY-TT-039 (NCT01900899) and MENACWY-TT-048 EXT (NCT01900899) were followed up for persistence of immune response and safety for a maximum duration of 6 years.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-TT Vaccine Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years. | 159 |
| MenCCRM Vaccine Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years. | 25 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Migrated from study area | 2 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 1 |
Baseline characteristics
| Characteristic | Total | MenACWY-TT Vaccine | MenCCRM Vaccine |
|---|---|---|---|
| Age, Continuous | 90.1 months STANDARD_DEVIATION 5.99 | 90.2 months STANDARD_DEVIATION 6.06 | 89.6 months STANDARD_DEVIATION 5.56 |
| Race/Ethnicity, Customized Ethnicity: American hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity: Non American hispanic | 183 Participants | 159 Participants | 24 Participants |
| Race/Ethnicity, Customized Race: Other | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race: White-Caucasian | 182 Participants | 158 Participants | 24 Participants |
| Sex: Female, Male Female | 84 Participants | 74 Participants | 10 Participants |
| Sex: Female, Male Male | 100 Participants | 85 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 0 / 25 |
| other Total, other adverse events | 1 / 159 | 0 / 25 |
| serious Total, serious adverse events | 0 / 159 | 0 / 25 |
Outcome results
Primary
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 36 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenA | 95.6 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenC | 88.1 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenW-135 | 97.8 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenY | 94.8 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenY | 36.4 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenA | 18.2 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenW-135 | 9.1 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination | rSBA-MenC | 77.3 percentage of participants |
Primary
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 48 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenA | 95.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenC | 88.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenW-135 | 87.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenY | 95.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenY | 43.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenA | 26.1 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenW-135 | 17.4 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination | rSBA-MenC | 100.0 percentage of participants |
Primary
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 60 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenA | 89.8 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenC | 80.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenW-135 | 88.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenY | 92.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenY | 26.1 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenA | 0.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenW-135 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination | rSBA-MenC | 78.3 percentage of participants |
Primary
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 72 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenA | 92.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenC | 71.6 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenW-135 | 85.8 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenY | 94.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenY | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenA | 8.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenW-135 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination | rSBA-MenC | 65.2 percentage of participants |
Primary
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N (overall number of participants analyzed)=number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenA | 98.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenC | 97.6 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenW-135 | 96.7 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenY | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenY | 33.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenA | 23.8 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenW-135 | 9.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination | rSBA-MenC | 100.0 percentage of participants |
Secondary
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to the Month 72 after booster vaccination (up to 6 years)
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MenACWY-TT Vaccine | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 0 participants |
| MenCCRM Vaccine | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 0 participants |
Secondary
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenW-135>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenW-135>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenY>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenA>=1:4 | 77.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenW-135>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenY>=1:4 | 99.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenA>=1:4 | 72.9 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenC>=1:4 | 98.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenA>=1:4 | 70.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenY>=1:4 | 97.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenA>=1:4 | 53.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenC>=1:4 | 99.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenW-135>=1:4 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenY>=1:4 | 97.8 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenA>=1:4 | 58.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenC>=1:4 | 98.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenW-135>=1:4 | 98.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenY>=1:4 | 97.7 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenA>=1:8 | 70.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenC>=1:8 | 99.2 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenW-135>=1:8 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenY>=1:8 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenA>=1:8 | 77.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenC>=1:8 | 99.2 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenW-135>=1:8 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenY>=1:8 | 99.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenA>=1:8 | 71.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenC>=1:8 | 97.7 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenW-135>=1:8 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenY>=1:8 | 97.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenA>=1:8 | 53.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenC>=1:8 | 99.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenW-135>=1:8 | 100.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenY>=1:8 | 97.8 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenA>=1:8 | 58.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenC>=1:8 | 97.7 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenW-135>=1:8 | 98.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenY>=1:8 | 97.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenC>=1:8 | 95.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenA>=1:4 | 14.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenA>=1:8 | 14.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenW-135>=1:8 | 4.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenW-135>=1:4 | 15.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenC>=1:8 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenY>=1:4 | 28.6 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenY>=1:8 | 40.9 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenA>=1:4 | 14.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenW-135>=1:8 | 15.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenY>=1:8 | 28.6 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenW-135>=1:4 | 18.2 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 24: hSBA-MenY>=1:8 | 28.6 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenY>=1:4 | 40.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenY>=1:8 | 33.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenA>=1:4 | 34.8 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenA>=1:8 | 9.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenA>=1:8 | 0.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenW-135>=1:4 | 4.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenC>=1:8 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenY>=1:4 | 28.6 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenA>=1:8 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenA>=1:4 | 0.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenW-135>=1:8 | 18.2 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenC>=1:8 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenW-135>=1:4 | 4.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 36: hSBA-MenY>=1:8 | 40.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenY>=1:4 | 40.9 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenW-135>=1:8 | 9.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenA>=1:4 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenA>=1:8 | 34.8 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenC>=1:4 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 60: hSBA-MenW-135>=1:8 | 4.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenW-135>=1:4 | 9.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 48: hSBA-MenC>=1:8 | 100.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups | Month 72: hSBA-MenY>=1:4 | 33.3 percentage of participants |
Secondary
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenA-1:128 | 95.1 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenC-1:128 | 74.8 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenW-135-1:128 | 94.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenY-1:128 | 94.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenA-1:128 | 83.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenC-1:128 | 46.7 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenW-135-1:128 | 88.1 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenY-1:128 | 84.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenA-1:128 | 83.5 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenC-1:128 | 46.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenW-135-1:128 | 73.9 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenY-1:128 | 82.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenA-1:128 | 73.0 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenC-1:128 | 47.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenW-135-1:128 | 69.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenY-1:128 | 77.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenA-1:128 | 78.4 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenC-1:128 | 40.3 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenW-135-1:128 | 67.2 percentage of participants |
| MenACWY-TT Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenY-1:128 | 75.4 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenC-1:128 | 34.8 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenA-1:128 | 14.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenW-135-1:128 | 17.4 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenC-1:128 | 85.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenY-1:128 | 21.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenW-135-1:128 | 9.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenY-1:128 | 43.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 24: rSBA-MenY-1:128 | 33.3 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenY-1:128 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenA-1:128 | 13.6 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenA-1:128 | 0.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenC-1:128 | 40.9 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenA-1:128 | 8.7 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenW-135-1:128 | 9.1 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenC-1:128 | 43.5 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 36: rSBA-MenY-1:128 | 36.4 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 72: rSBA-MenW-135-1:128 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenA-1:128 | 17.4 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 60: rSBA-MenW-135-1:128 | 13.0 percentage of participants |
| MenCCRM Vaccine | Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups | Month 48: rSBA-MenC-1:128 | 47.8 percentage of participants |
Secondary
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenY | 315.6 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenA | 33.2 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenC | 510.08 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenW-135 | 991.3 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenY | 575.4 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenA | 44.6 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenC | 343.3 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenW-135 | 738.8 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenY | 691.9 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenA | 27.7 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenC | 232.3 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenW-135 | 600.0 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenY | 495.0 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenA | 13.2 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenC | 337.1 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenW-135 | 326.8 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenY | 398.7 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenA | 14.4 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenC | 259.1 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenW-135 | 314.4 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenA | 2.8 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenY | 8.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenC | 182.6 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenA | 2.9 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenW-135 | 2.4 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenC | 424.9 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenW-135 | 2.3 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenW-135 | 3.4 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenW-135 | 2.5 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: hSBA-MenY | 4.6 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenY | 5.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenA | 2.6 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenY | 7.6 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenC | 226.7 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenA | 2.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenW-135 | 3.5 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: hSBA-MenC | 169.4 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: hSBA-MenY | 7.4 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: hSBA-MenC | 241.3 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: hSBA-MenA | 4.2 titers |
Secondary
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Population: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenW-135 | 859.9 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenW-135 | 224.7 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenC | 70.6 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenY | 335.1 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenA | 229.0 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenC | 174.5 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenC | 66.0 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenW-135 | 544.5 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenW-135 | 184.3 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenY | 734.4 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenY | 265.2 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenY | 416.9 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenA | 297.4 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenA | 1071.2 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenC | 39.6 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenA | 413.2 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenW-135 | 171.9 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenA | 376.3 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenY | 260.0 titers |
| MenACWY-TT Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenC | 69.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenY | 8.8 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenA | 9.1 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenC | 224.3 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenW-135 | 6.6 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 24: rSBA-MenY | 18.9 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenA | 8.8 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenC | 54.7 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenW-135 | 6.4 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 36: rSBA-MenY | 20.6 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenA | 10.8 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenC | 62.1 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenW-135 | 9.3 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenA | 4.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenC | 47.3 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenW-135 | 8.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 60: rSBA-MenY | 13.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenA | 5.7 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenC | 33.0 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 72: rSBA-MenW-135 | 7.3 titers |
| MenCCRM Vaccine | Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups | Month 48: rSBA-MenY | 28.4 titers |