Infections, Meningococcal
Conditions
Keywords
Healthy, Adults, Safety, Neisseria meningitidis, Booster response, Immunogenicity, Adolescents, Serogroups A, C, W-135, and Y, long-term antibody persistence
Brief summary
The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated. All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
1 dose administered intramuscularly in the non-dominant deltoid region.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 66 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria at study entry to the persistence phase: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and 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 between and including 17 and 66 years of age at the time of entry into the present study. * Has completed the vaccination phase of the vaccination study MENACWY-TT-015. * In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects ≥18 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent. * Healthy subjects as established by medical history and history-directed physical examination before entering into the study. All subjects must satisfy the following additional criteria prior to entry of the booster phase: * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Child in care. * Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015. * History of meningococcal disease due to serogroup A, C, W-135 or Y. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination. * Major congenital defects or serious chronic illness. * Family history of congenital or hereditary immunodeficiency. * History of chronic alcohol consumption and/or drug abuse. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination | After 6 years of primary 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). |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | After 7 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | After 8 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | After 9 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | After 10 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination | After 6 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units. |
| Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | After 7 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units. |
| Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | After 8 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units. |
| Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | After 9 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units. |
| Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | After 10 years of primary vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | 1 month after booster vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. |
| Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | Up to 6 months post booster vaccination | Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis (also termed meningococcus). It causes two life threatening diseases: meningococcal meningitis and fulminant meningococcemia which often occur together. Meningococcal meningitis is defined as an inflammatory response to bacterial infection of leptomeninges (pia-arachnoid) and the sub-arachnoid space. Meningococcal meningococcemia is meningococcal septicemia when the bacteria circulate and multiply in blood and involve multiple organs. It can cause multi-organ failure and severe disability or death. |
| Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | 1 month after booster vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units. |
| Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | 1 month after booster vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster vaccine responses for serogroups A, C, W-135 and Y defined as: for initially seronegative participants (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers \>= 1:32, 1 month after vaccination, and for initially seropositive participants (pre-vaccination titer \>= 1:8) had rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination. Data reported below is including both seropositive and seronegative participants. |
| Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After 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. |
| Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination | 1 month after booster vaccination | 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. |
| Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Up to 4 days post booster vaccination | Solicited local events:1)pain(Grade \[G\] : 0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, painful when limb moved; interfered with normal activities,3=severe, significant pain at rest,prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre\[mm\] as 0 to less than or equal to\[\<=\]20 mm, greater than\[\>\]20 to \<=50 mm,\>50 mm). If to resolve any event medical advice taken, results reported as Medical Advice. Solicited general events: 1) fatigue, 2) gastrointestinal(GI) events(nausea, vomiting, diarrhea and/or abdominal pain,3) headache(G : 0=normal, 1=mild, easily tolerated,2=moderate, interfered with normal activity,3=severe, prevented normal activity), and 4)fever (G: 0=less than\[\<\] 37.5 degree Celsius\[°C\], 1= 37.5 degree C to 38.0degree C, 2= 38.1 degreeC to 39.0 degree C,3 =\>39.0 degree C). 'Related'=relationship to study vaccine assessed by investigator.Medical advice=medical advice received to resolve any event. |
| Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post Booster Vaccination | Up to 31 days post 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. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | Up to 6 months post booster vaccination | 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. |
| Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | Up to 6 months post booster vaccination | New onset chronic illness included autoimmune disorders, asthma, type I diabetes, and allergies. |
| Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | Up to 6 months post booster vaccination | Guillain-Barre syndrome (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. |
Countries
Philippines
Participant flow
Recruitment details
Enrollment for this study (MENACWY-TT-99) started at Year 6 post primary vaccination in study 107386 \[NCT00356369\]. However, as approval was not obtained from authorities until after end of Year 6, hence no planned activities was done for Year 6.
Pre-assignment details
In this study, participants from the study 107386 \[NCT00356369\] were followed up for assessment of persistence of immune response. And those who consented received booster vaccination and were followed up for another 6 months.
Participants by arm
| Arm | Count |
|---|---|
| ACWY-TT Group Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination. | 235 |
| MenPS Group Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination. | 76 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Booster Phase (6 Months) | Lost to Follow-up | 1 | 0 |
| Booster Phase (6 Months) | Migrated/moved from study area | 2 | 2 |
| Booster Phase (6 Months) | Missed at least 1 booster visit | 2 | 1 |
| Persistence Phase (Year 6-10) | Eligibility criteria not fulfilled | 2 | 0 |
| Persistence Phase (Year 6-10) | Lost to Follow-up | 5 | 2 |
| Persistence Phase (Year 6-10) | Migrated/moved from study area | 31 | 10 |
| Persistence Phase (Year 6-10) | Missed at least 1 persistence visit | 21 | 7 |
| Persistence Phase (Year 6-10) | Other | 24 | 6 |
Baseline characteristics
| Characteristic | MenPS Group | Total | ACWY-TT Group |
|---|---|---|---|
| Age, Continuous | 25.2 years STANDARD_DEVIATION 8.4 | 25.2 years STANDARD_DEVIATION 8.2 | 25.3 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 311 Participants | 235 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 76 Participants | 311 Participants | 235 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 40 Participants | 148 Participants | 108 Participants |
| Sex: Female, Male Male | 36 Participants | 163 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 76 | 0 / 164 | 0 / 56 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 66 / 164 | 20 / 56 |
| serious Total, serious adverse events | 0 / 235 | 0 / 76 | 0 / 164 | 0 / 56 |
Outcome results
Primary
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 10 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this measure and n: participants analyzed for specified serogroup.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenA | 142.5 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenC | 181.4 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenW-135 | 161.5 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenY | 387.0 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenY | 63.2 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenA | 73.7 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenW-135 | 11.9 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenC | 234.0 titers |
Primary
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Time frame: After 6 years of primary vaccination
Population: Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.
Primary
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 7 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenA | 220.8 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenC | 105.3 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenW-135 | 83.2 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenY | 270.2 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenY | 32.7 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenA | 54.5 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenW-135 | 10.0 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenC | 156.7 titers |
Primary
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 8 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this measure and n: participants analyzed for specified serogroup.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenC | 155.4 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenA | 104.8 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenW-135 | 119.7 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenY | 181.6 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenY | 26.0 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenW-135 | 10.8 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenA | 44.1 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenC | 240.6 titers |
Primary
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: After 9 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen.Here, N signifies number of participants evaluable for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenA | 227.8 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenC | 173.3 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenW-135 | 71.7 titers |
| ACWY-TT Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenY | 460.6 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenY | 57.8 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenA | 81.2 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenW-135 | 6.7 titers |
| MenPS Group | Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenC | 264.9 titers |
Primary
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 10 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this measure and n: participants analyzed for specified serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 76.5 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 90.7 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 70.2 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 87.0 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 67.9 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 72.7 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 64.6 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 83.2 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 53.7 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 70.4 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 57.4 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 88.9 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 22.2 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 24.1 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 68.5 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 64.8 percentage of participants |
Primary
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 7 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, Overall Number of Participants Analyzed (N) signifies number of participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 88.3 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 82.5 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 60.7 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 80.1 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 73.8 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 61.7 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 52.4 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 76.7 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 38.5 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 67.7 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 46.2 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 76.9 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 16.9 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 23.1 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 61.5 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 46.2 percentage of participants |
Primary
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 8 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this measure and Number analyzed (n): participants analyzed for specified serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 76.0 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 86.3 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 66.2 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 76.2 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 60.6 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 68.1 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 60.9 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 70.9 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 37.3 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 56.7 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 40.3 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 80.6 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 16.4 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 23.9 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 64.2 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 40.3 percentage of participants |
Primary
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: After 9 years of primary vaccination
Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 82.6 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 89.5 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 55.8 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 89.5 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 75.3 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 66.8 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 50.5 percentage of participants |
| ACWY-TT Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 86.3 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenY: >=1:128 | 50.8 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenA: >=1:8 | 65.6 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenA: >=1:128 | 59.0 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenC: >=1:8 | 90.2 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenW-135: >=1:128 | 9.8 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenW-135: >=1:8 | 9.8 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenC: >=1:128 | 67.2 percentage of participants |
| MenPS Group | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | rSBA-MenY: >=1:8 | 57.4 percentage of participants |
Primary
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary 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).
Time frame: After 6 years of primary vaccination
Population: Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.
Secondary
Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination
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: 1 month after booster vaccination
Population: All eligible participants who received primary vaccination in study107386 \[NCT00356369\], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ACWY-TT Group | Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination | 7.163 IU/mL |
| MenPS Group | Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination | 7.650 IU/mL |
Secondary
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Time frame: 1 month after booster vaccination
Population: All eligible participants who received primary vaccination in study107386 \[NCT00356369\], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of participants evaluable for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACWY-TT Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenA | 4059.5 titers |
| ACWY-TT Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenW-135 | 23431.0 titers |
| ACWY-TT Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenC | 13823.5 titers |
| ACWY-TT Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenY | 8958.4 titers |
| MenPS Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenC | 3444.3 titers |
| MenPS Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenA | 3584.8 titers |
| MenPS Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenY | 5137.8 titers |
| MenPS Group | Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenW-135 | 5792.6 titers |
Secondary
Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 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: 1 month after booster vaccination
Population: All eligible participants who received primary vaccination in study107386 \[NCT00356369\], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination | Anti-TT >=0.1 IU/mL | 99.4 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination | Anti-TT >=1.0 IU/mL | 94.8 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination | Anti-TT >=0.1 IU/mL | 98.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination | Anti-TT >=1.0 IU/mL | 88.5 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Guillain-Barre syndrome (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.
Time frame: Up to 6 months post booster vaccination
Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis (also termed meningococcus). It causes two life threatening diseases: meningococcal meningitis and fulminant meningococcemia which often occur together. Meningococcal meningitis is defined as an inflammatory response to bacterial infection of leptomeninges (pia-arachnoid) and the sub-arachnoid space. Meningococcal meningococcemia is meningococcal septicemia when the bacteria circulate and multiply in blood and involve multiple organs. It can cause multi-organ failure and severe disability or death.
Time frame: Up to 6 months post booster vaccination
Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
New onset chronic illness included autoimmune disorders, asthma, type I diabetes, and allergies.
Time frame: Up to 6 months post booster vaccination
Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster vaccine responses for serogroups A, C, W-135 and Y defined as: for initially seronegative participants (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers \>= 1:32, 1 month after vaccination, and for initially seropositive participants (pre-vaccination titer \>= 1:8) had rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination. Data reported below is including both seropositive and seronegative participants.
Time frame: 1 month after booster vaccination
Population: All eligible participants: received primary vaccination in study 107386\[NCT00356369\] and booster dose in study MENACWY-099;assay results available for antibodies against at least 1 study vaccine antigen component in blood sample taken 1 month post vaccination. N=participants evaluable for measure, n=participants analyzed for specified serogroups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenA | 87.7 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenC | 90.9 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenW-135 | 94.2 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenY | 83.8 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenY | 92.3 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenA | 88.5 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenW-135 | 96.2 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | rSBA-MenC | 75.0 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Time frame: 1 month after booster vaccination
Population: All eligible participants who received primary vaccination in study107386 \[NCT00356369\], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenY: >=1:8 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenA: >=1:128 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenC: >=1:128 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:128 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenY: >=1:128 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenA: >=1:8 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenC: >=1:8 | 100.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:8 | 100.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:8 | 98.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenY: >=1:8 | 100.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenY: >=1:128 | 100.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenA: >=1:128 | 100.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenC: >=1:8 | 98.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenC: >=1:128 | 96.2 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenA: >=1:8 | 100.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | rSBA-MenW-135: >=1:128 | 98.1 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
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.
Time frame: Up to 6 months post booster vaccination
Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination) | 0 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Solicited local events:1)pain(Grade \[G\] : 0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, painful when limb moved; interfered with normal activities,3=severe, significant pain at rest,prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre\[mm\] as 0 to less than or equal to\[\<=\]20 mm, greater than\[\>\]20 to \<=50 mm,\>50 mm). If to resolve any event medical advice taken, results reported as Medical Advice. Solicited general events: 1) fatigue, 2) gastrointestinal(GI) events(nausea, vomiting, diarrhea and/or abdominal pain,3) headache(G : 0=normal, 1=mild, easily tolerated,2=moderate, interfered with normal activity,3=severe, prevented normal activity), and 4)fever (G: 0=less than\[\<\] 37.5 degree Celsius\[°C\], 1= 37.5 degree C to 38.0degree C, 2= 38.1 degreeC to 39.0 degree C,3 =\>39.0 degree C). 'Related'=relationship to study vaccine assessed by investigator.Medical advice=medical advice received to resolve any event.
Time frame: Up to 4 days post booster vaccination
Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099. n participants analyzed for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All redness | 5.7 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All fever | 6.9 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: 0 to <=20 mm | 3.8 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 1 | 6.3 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Pain: Grade 1 | 20.8 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 2 | 0.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: >20 to <=50 mm | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 3 | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: 0 to <=20 mm | 5.7 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Related | 6.9 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: >50 mm | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 3 related | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Severe pain: Grade 3 | 0.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Medical advice | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: Medical advice | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All GI | 4.4 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: >20 to <=50 mm | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 1 | 3.8 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All fatigue | 14.5 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 2 | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All pain | 27.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 3 | 0.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 1 | 10.7 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Related | 3.8 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: >50 mm | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 3 related | 0.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 2 | 3.1 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI:Medical advice | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Pain: Medical advice | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All headache | 15.7 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 3 | 0.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 1 | 12.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: Medical advice | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 2 | 1.9 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Related fatigue | 12.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 3 | 1.3 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Pain: Grade 2 | 5.7 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Related | 13.8 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 3 Related | 0.6 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 3 related | 1.3 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All swelling | 3.8 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Medical advice | 0.0 percentage of participants |
| ACWY-TT Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Pain: Grade 1 | 24.5 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Pain: Grade 2 | 1.9 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Severe pain: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Pain: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All redness | 3.8 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: 0 to <=20 mm | 3.8 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: >20 to <=50 mm | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: >50 mm | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Redness: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All swelling | 5.7 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: 0 to <=20 mm | 5.7 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: >20 to <=50 mm | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: >50 mm | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Swelling: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All fatigue | 15.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 1 | 15.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Related fatigue | 15.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Grade 3 Related | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fatigue: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All fever | 5.7 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 1 | 5.7 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Related | 5.7 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Grade 3 related | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Fever: Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All GI | 1.9 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 1 | 1.9 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Related | 1.9 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI: Grade 3 related | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | GI:Medical advice | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All headache | 9.4 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 1 | 9.4 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 2 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 3 | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Related | 9.4 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Headache: Grade 3 related | 0.0 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | All pain | 26.4 percentage of participants |
Secondary
Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post 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. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Up to 31 days post booster vaccination
Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-TT Group | Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post Booster Vaccination | 9.1 percentage of participants |
| MenPS Group | Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post Booster Vaccination | 3.6 percentage of participants |