| 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). | Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities. | Posted | | | | | | After 6 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | After 7 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | After 8 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | After 9 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | After 10 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities. | Posted | | | | | | After 6 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | After 7 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | After 8 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | MenPS Group | |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | After 9 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | After 10 years of primary vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | MenPS Group | |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | MenPS Group |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | MenPS Group |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Up to 4 days post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099. | Posted | | Number | | percentage of participants | | Up to 31 days post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099. | Posted | | Number | | percentage of participants | | Up to 6 months post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 |
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| 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. | All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099. | Posted | | Number | | percentage of participants | | Up to 6 months post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099. | Posted | | Number | | percentage of participants | | Up to 6 months post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | MenPS Group |
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| 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. | All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099. | Posted | | Number | | percentage of participants | | Up to 6 months post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. |
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