Meningococcal ACWY Disease
Conditions
Brief summary
This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY
Interventions
BIOLOGICALMenACWY-TT
Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 28 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the subject prior to performing any study specific procedure. * Healthy male or female subjects as established by medical history and history-directed physical examination before entering into the study. * Having completed the vaccination in study MenACWY-TT-036 (109069) as per protocol. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral ovariectomy or post-menopause. Please refer to the GLOSSARY OF TERMS for the definitions of menarche and post-menopause. * Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk for pregnancy 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 (for females only), and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will be 10 mg/day prednisone, or equivalent. Inhaled, topical, and intra-articular steroids are allowed. * Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2). * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the MenACWY-TT-036 study. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus infection, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted. * Acute disease and/or fever at the time of vaccination. * Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be vaccinated at the discretion of the investigator. * Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Male subjects able to father children who are planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | 1 month after booster vaccination | Serogroups included: Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). The rSBA titer levels greater than or equal to (\>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer \>=1:8. Data reported below is including both seropositive and seronegative participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | Before booster vaccination, 1 month after booster vaccination (Vac) | Serogroups included MenA, MenC, MenW-135 and MenY. |
| rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | Before booster vaccination, 1 month after booster vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units. |
| Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | Before booster vaccination, 1 month after booster vaccination | Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration \>=0.1 IU/mL, \>=1.0 IU/mL were summarized. |
| Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | Before booster vaccination, 1 month after booster vaccination | TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. The GMCs calculations was performed by taking the anti-log of the mean of the log concentration transformations. Antibody (Anti-TT) concentrations below the cut-off value (0.1 IU/mL) of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation. |
| Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | Within 31 days after booster vaccination (Day 0 to Day 30) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. GBS is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system-the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently. All occurrences of GBS has to be reported as an SAE. New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies. |
| Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | 10 years after primary vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Occurrence of SAEs related to primary vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the participant's last visit in the primary study 109069 (NCT00464815) or in persistence study 112148 (NCT00974363); extension study: 109069 (NCT00464815) at Year 2, 3, 4, 5 after primary vaccination until entry in study MenACWYTT-101, which is extension of study 109069 (NCT00464815), 10 years post primary vaccination. |
| Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Within 4 days post booster vaccination (Day 0 to Day 3) | Solicited local reactions included pain, redness and swelling. Pain graded as: (0= none, 1= mild, not interfered/prevented normal activity, 2= moderate, painful when limb moved/interfered with normal activity, 3= severe, significant pain at rest/ prevented normal activity). Redness and swelling scored as:0= None, 1= 0 to less than or equal to (\<=) 20 millimeter (mm), 2= greater than (\>) 20 to \<=50 mm, 3=\>50 mm. Solicited general reactions: headache, fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea /abdominal pain) graded as (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe / prevented normal activity). Fever categorized as: 0= less than (\<) 37.5 degree Celsius (C), 1= \>=37.5 to \<=38.5 degree C, 2= \>38.5 to \<=39.5 degree C, and 3= \>39.5 degree C. |
| Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination | 31 days after booster vaccination (Day 0 to Day 30) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. And any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | 10 years after primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | 10 years after primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. |
Countries
Philippines
Participant flow
Pre-assignment details
Participants who received either MenACWY-TT (NIMENRIX) or Mencevax ACWY vaccine in study 109069 (NCT00464815) were administered a MenACWY-TT booster vaccination in this study and evaluated for immunogenicity, reactogenicity and safety parameters.
Participants by arm
| Arm | Count |
|---|---|
| ACWY-TT Group Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | 170 |
| MenPS Group Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | 59 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Conflict in work schedule of participant | 1 | 1 |
Baseline characteristics
| Characteristic | ACWY-TT Group | MenPS Group | Total |
|---|---|---|---|
| Age, Continuous | 24.2 years STANDARD_DEVIATION 1.9 | 24.0 years STANDARD_DEVIATION 2 | 24.1 years STANDARD_DEVIATION 2 |
| Race/Ethnicity, Customized Asian - South East Asian heritage | 170 Participants | 59 Participants | 229 Participants |
| Sex: Female, Male Female | 80 Participants | 23 Participants | 103 Participants |
| Sex: Female, Male Male | 90 Participants | 36 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 170 | 0 / 59 |
| other Total, other adverse events | 83 / 170 | 30 / 59 |
| serious Total, serious adverse events | 0 / 170 | 0 / 59 |
Outcome results
Primary
Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination
Serogroups included: Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). The rSBA titer levels greater than or equal to (\>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer \>=1:8. Data reported below is including both seropositive and seronegative participants.
Time frame: 1 month after booster vaccination
Population: Booster according-to-protocol(ATP)Cohort for immunogenicity: met booster ATP cohort for safety, comply procedures in protocol, meeting visit interval from primary vaccination(vac) in 109069 to booster vac,blood sampling intervals, had assay results with no vac before post booster vac blood draw.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenA | 81.5 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenC | 88.3 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenW-135 | 95.7 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenY | 87.0 percentage of participants |
| MenPS Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenY | 90.2 percentage of participants |
| MenPS Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenA | 84.3 percentage of participants |
| MenPS Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenW-135 | 94.1 percentage of participants |
| MenPS Group | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | rSBA-MenC | 66.7 percentage of participants |
Secondary
Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination
TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. The GMCs calculations was performed by taking the anti-log of the mean of the log concentration transformations. Antibody (Anti-TT) concentrations below the cut-off value (0.1 IU/mL) of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation.
Time frame: Before booster vaccination, 1 month after booster vaccination
Population: Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069 (NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | Before booster vaccination | 0.608 IU/mL |
| ACWY-TT Group | Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | 1 month after booster vaccination | 5.057 IU/mL |
| MenPS Group | Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | Before booster vaccination | 0.252 IU/mL |
| MenPS Group | Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | 1 month after booster vaccination | 5.115 IU/mL |
Secondary
Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination
Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration \>=0.1 IU/mL, \>=1.0 IU/mL were summarized.
Time frame: Before booster vaccination, 1 month after booster vaccination
Population: Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069 (NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=0.1 IU/mL; Before booster vaccination | 86.4 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=0.1 IU/mL;1 month after booster vaccination | 98.8 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=1.0 IU/mL; Before booster vaccination | 38.3 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=1.0 IU/mL; 1 month after booster vaccination | 92.0 percentage of participants |
| MenPS Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=1.0 IU/mL; 1 month after booster vaccination | 82.4 percentage of participants |
| MenPS Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=0.1 IU/mL; Before booster vaccination | 54.9 percentage of participants |
| MenPS Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=1.0 IU/mL; Before booster vaccination | 27.5 percentage of participants |
| MenPS Group | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | >=0.1 IU/mL;1 month after booster vaccination | 96.1 percentage of participants |
Secondary
Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: Before booster vaccination, 1 month after booster vaccination (Vac)
Population: Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069(NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY: >=1:28; Before booster vaccination | 85.2 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY: >=1:8; Before booster vaccination | 90.7 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC: >=1:8; Before booster vaccination | 90.1 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY: >=1:8;1 month after booster vaccination | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA: >=1:8; Before booster vaccination | 85.2 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA: >=1:28; Before booster vaccination | 81.5 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC: >=1:8;1 month after booster vaccination | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA:>=1:28;1 month after booster vaccination | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY:>=1:28;1 month after booster vaccination | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC: >=1:28; Before booster vaccination | 77.2 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:8; Before booster vaccination | 71.6 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC:>=1:28;1 month after booster vaccination | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA: >=1:8;1 month after booster vaccination | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:28; Before booster vaccination | 64.8 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135:>=1:8;1month after booster vac | 100.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135:>=1:28;1month after booster vac | 100.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135:>=1:8;1month after booster vac | 100.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY: >=1:28; Before booster vaccination | 39.2 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY:>=1:28;1 month after booster vaccination | 96.1 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA: >=1:8; Before booster vaccination | 80.4 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA: >=1:8;1 month after booster vaccination | 100.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC: >=1:8; Before booster vaccination | 82.4 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC: >=1:8;1 month after booster vaccination | 100.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:8; Before booster vaccination | 43.1 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135:>=1:28;1month after booster vac | 98.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY: >=1:8; Before booster vaccination | 49.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY: >=1:8;1 month after booster vaccination | 98.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA: >=1:28; Before booster vaccination | 76.5 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA:>=1:28;1 month after booster vaccination | 100.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC: >=1:28; Before booster vaccination | 62.7 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC:>=1:28;1 month after booster vaccination | 100.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:28; Before booster vaccination | 25.5 percentage of participants |
Secondary
Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Occurrence of SAEs related to primary vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the participant's last visit in the primary study 109069 (NCT00464815) or in persistence study 112148 (NCT00974363); extension study: 109069 (NCT00464815) at Year 2, 3, 4, 5 after primary vaccination until entry in study MenACWYTT-101, which is extension of study 109069 (NCT00464815), 10 years post primary vaccination.
Time frame: 10 years after primary vaccination
Population: The total cohort at Month 120 (10 years post primary vaccination) included all vaccinated participants from the vaccination of Study 109069 (NCT00464815) who return for the Month 120 follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | SAEs | 0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | Events related to lack of vac efficacy | 0 percentage of participants |
| MenPS Group | Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | SAEs | 0 percentage of participants |
| MenPS Group | Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | Events related to lack of vac efficacy | 0 percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. GBS is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system-the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently. All occurrences of GBS has to be reported as an SAE. New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: Within 31 days after booster vaccination (Day 0 to Day 30)
Population: Booster TVC for safety included all vaccinated participants in study 109069 (NCT00464815) with a MenACWY-TT booster vaccine administration documented in study MENACWY-TT-101.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | SAEs | 0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | GBS | 0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | NOCI | 0 percentage of participants |
| MenPS Group | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | SAEs | 0 percentage of participants |
| MenPS Group | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | GBS | 0 percentage of participants |
| MenPS Group | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | NOCI | 0 percentage of participants |
Secondary
Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination
Solicited local reactions included pain, redness and swelling. Pain graded as: (0= none, 1= mild, not interfered/prevented normal activity, 2= moderate, painful when limb moved/interfered with normal activity, 3= severe, significant pain at rest/ prevented normal activity). Redness and swelling scored as:0= None, 1= 0 to less than or equal to (\<=) 20 millimeter (mm), 2= greater than (\>) 20 to \<=50 mm, 3=\>50 mm. Solicited general reactions: headache, fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea /abdominal pain) graded as (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe / prevented normal activity). Fever categorized as: 0= less than (\<) 37.5 degree Celsius (C), 1= \>=37.5 to \<=38.5 degree C, 2= \>38.5 to \<=39.5 degree C, and 3= \>39.5 degree C.
Time frame: Within 4 days post booster vaccination (Day 0 to Day 3)
Population: Booster total vaccinated cohort (TVC) for safety included all vaccinated participants in study 109069 (NCT00464815) with a MenACWY-TT booster vaccine administration documented in study MENACWY-TT-101. Here, Overall Number of Participants Analyzed (N) signifies number of participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Pain: Grade 1 | 29.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Pain: Grade 2 | 4.7 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Pain: Grade 3 | 1.2 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Redness: Grade 1 | 10.1 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Redness: Grade 2 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Redness: Grade 3 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Swelling: Grade 1 | 7.7 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Swelling: Grade 2 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Swelling: Grade 3 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fatigue: Grade 1 | 16.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fatigue: Grade 2 | 1.8 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fatigue: Grade 3 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fever: Grade 1 | 4.1 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fever: Grade 2 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fever: Grade 3 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | GI: Grade 1 | 9.5 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | GI: Grade 2 | 1.8 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | GI: Grade 3 | 0.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Headache: Grade 1 | 21.3 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Headache: Grade 2 | 3.6 percentage of participants |
| ACWY-TT Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Headache: Grade 3 | 0.6 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fatigue: Grade 2 | 5.2 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Pain: Grade 1 | 31.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Headache: Grade 1 | 15.5 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Pain: Grade 2 | 1.7 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fatigue: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Pain: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | GI: Grade 2 | 3.4 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Redness: Grade 1 | 8.6 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fever: Grade 1 | 3.4 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Redness: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Headache: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Redness: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fever: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Swelling: Grade 1 | 3.4 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | GI: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Swelling: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fever: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Swelling: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Headache: Grade 2 | 6.9 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Fatigue: Grade 1 | 19.0 percentage of participants |
| MenPS Group | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | GI: Grade 1 | 6.9 percentage of participants |
Secondary
Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. And any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: 31 days after booster vaccination (Day 0 to Day 30)
Population: Booster TVC for safety included all vaccinated participants in study 109069 (NCT00464815) with a MenACWY-TT booster vaccine administration documented in study MENACWY-TT-101.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-TT Group | Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination | 9.4 percentage of participants |
| MenPS Group | Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination | 15.3 percentage of participants |
Secondary
rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Time frame: Before booster vaccination, 1 month after booster vaccination
Population: Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069 (NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA; Before booster vaccination | 248.4 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA;1 month after booster vaccination | 3760.1 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC; Before booster vaccination | 244.2 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC;1 month after booster vaccination | 8697.7 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135; Before booster vaccination | 145.5 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135;1 month after booster vaccination | 11243.4 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY; Before booster vaccination | 446.5 titers |
| ACWY-TT Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY; 1 month after booster vaccination | 7584.8 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY; 1 month after booster vaccination | 3295.5 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA; Before booster vaccination | 142.7 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135; Before booster vaccination | 16.4 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenA;1 month after booster vaccination | 2956.0 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenY; Before booster vaccination | 32.9 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC; Before booster vaccination | 177.4 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenW-135;1 month after booster vaccination | 3674.0 titers |
| MenPS Group | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | rSBA-MenC;1 month after booster vaccination | 3879.3 titers |
Other Pre-specified
Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units.
Time frame: 10 years after primary vaccination
Population: ATP Cohort for Persistence at Month 120: participants who eligible in Study 109069 (NCT00464815), received primary vaccination with MenACWY-TT or Mencevax ACWY during Study 109069, had assay results for at least one tested antigen at Month 120, did not received a meningococcal vaccine not planned in Study 109069 before Month 120 visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenA | 242.2 titers |
| ACWY-TT Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenW-135 | 146.0 titers |
| ACWY-TT Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenC | 243.3 titers |
| ACWY-TT Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenY | 446.9 titers |
| MenPS Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenY | 31.6 titers |
| MenPS Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenA | 153.7 titers |
| MenPS Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenC | 182.2 titers |
| MenPS Group | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenW-135 | 15.6 titers |
Other Pre-specified
Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 10 years after primary vaccination
Population: ATP Cohort for Persistence at Month 120: participants who eligible in Study 109069 (NCT00464815), received primary vaccination with MenACWY-TT or Mencevax ACWY during Study 109069, had assay results for at least one tested antigen at Month 120, did not received a meningococcal vaccine not planned in Study 109069 before Month 120 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenA: >=1:8 | 84.7 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenC: >=1:8 | 90.2 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenW-135: >=1:8 | 71.8 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenY: >=1:8 | 90.8 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenA: >=1:128 | 81.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenC: >=1:128 | 77.3 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenW-135: >=1:128 | 65.0 percentage of participants |
| ACWY-TT Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenY: >=1:128 | 85.3 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenY: >=1:128 | 37.7 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenA: >=1:8 | 81.1 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenA: >=1:128 | 77.4 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenC: >=1:8 | 83.0 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenW-135: >=1:128 | 24.5 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenW-135: >=1:8 | 41.5 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenC: >=1:128 | 64.2 percentage of participants |
| MenPS Group | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | rSBA-MenY: >=1:8 | 49.1 percentage of participants |