The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China. Study details include: * Study duration (including 6-month safety follow-up after the last dose): * Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months) * Cohort II (Groups 3 and 4): up to 18 months * Cohort III (Groups 5 and 6): up to 21 months * Cohort III (Group 7): approximately 16 months * Vaccination Visits Period: * Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121). Telephone calls (TCs) are planned on the 4th, the 9th, and the 21st day after each vaccination, and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection. \- Cohort II (Groups 3 and 4): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). A 1-dose booster is planned for Group 3 only at 18 MoA (within the 18th month from the participant's birth date). Up to 4 blood samples will be collected. In the primary vaccination period, blood samples are collected before the first primary vaccination (D01) and 30 days post the 2nd dose of primary vaccination (D61 or D121). A blood sample will be collected from all participants at 18 MoA. A post-booster blood sample will be collected from participants in Group 3, 30 days post their booster vaccination. Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods, respectively, for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection. \- Cohort III - Groups 5 and 6: a 3-dose primary vaccination at V01 (D01), V02 (D31) and V03 (D61), a 1-dose booster at 12 MoA (within the 12th months from the participant's birth date) on V05 or at 18 MoA (within the 18th months from the participant's birth date) on V06. In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D91); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 (for participants receiving the booster at 12 MoA) or V06 (for participants receiving the booster at 18 MoA), and 30 days post booster vaccination (V05 + 30 days or V06 + 30 days). Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods respectively for safety follow-up. \- Cohort III - Group 7: a 3-dose primary vaccination at V01 (D01), V02 (D61) and V03 (D121), a 1-dose booster at V05 at 12 MoA (within the 12th months from the participant's birth date). In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D151); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 and 30 days post booster vaccination (V06). Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods (ie, V04 and V06), respectively, for safety follow-up. A safety visit is planned on the 9th day after the first vaccination for the ESDR participants (the first 30 participants in this group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,568
Pharmaceutical form:Liquid solution-Route of administration:IM injection
Pharmaceutical form:Lyophilized powder (MenAC conjugate vaccine) and liquid solution (MenYW135 conjugate vaccine)-Route of administration:IM injection
Investigational Site Number : 1561001
Jingxi, China
RECRUITINGInvestigational Site Number : 1561003
Liuzhou, China
RECRUITINGInvestigational Site Number : 1561000
Nanning, China
RECRUITINGInvestigational Site Number : 1561002
Tengzhou Town, China
RECRUITINGParticipants 12 through 23 MoA (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
30 days post-2nd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Time frame: 30 days post 2nd vaccination (up to Day 121)
Participants 12 through 23 MoA (Cohort I): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W measured by rSBA
30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine
Time frame: 30 days post 2nd vaccination (up to Day 121)
Participants 6 through 11 MoA (Cohort II): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
30 days post-2nd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Time frame: 30 days post 2nd vaccination (up to Day 121)
Participants 6 through 11 MoA (Cohort II): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
30 days (+10 days) post-2nd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine
Time frame: 30 days post 2nd vaccination (up to Day 121)
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
30 days post-3rd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Time frame: Day 91
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
Time frame: Day 91
Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
30 days post-3rd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Time frame: Day 151
Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7) or MenACYW135, CanSino conjugate vaccine (Group 6)
Time frame: Day 151
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time frame: Within 30 minutes post-vaccination
Presence of solicited injection site reactions
(pre-listed in the participant diary and CRF)
Time frame: for 8 days, including the day of each study vaccination.
Presence of solicited systemic reactions
(pre-listed in the participant diary and CRF)
Time frame: for 8 days, including the day of each study vaccination.
Presence of unsolicited AEs
Time frame: for 30 days including the day of each study vaccination.
Presence of SAEs
Time frame: Approximately 7 months to 9 months for Group 1 and Group 2; up to 18 months for participants from Group 3 and Group 4; up to 21◦months for participants from Group 5 and Group 6; Approximately 16 months for participants from Group 7
Presence of AEs leading to study discontinuation
Time frame: Approximately 7 months to 9 months for Group 1 and Group 2; up to 18 months for participants from Group 3 and Group 4; up to 21◦months for participants from Group 5 and Group 6; Approximately 16 months for participants from Group 7
Participants 12 through 23 MoA (Cohort I) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine.
Time frame: 30 days post 2nd vaccination (up to Day 121)
Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA
30 days (+10 days) post-2nd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine.
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Time frame: 30 days post 2nd vaccination (up to Day 121)
Participants 6 through 11 MoA (Cohort II) Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 18 MoA.
Time frame: at 18 MoA (up to Day 394)
Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA pre-booster dose at 18 MoA
Time frame: at 18 MoA (up to Day 394)
Participants 6 through 11 MoA (Cohort II) Antibody titers (in terms of GMTs) against booster meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine given at 18 MoA.
Time frame: at 18 MoA (up to Day 424)
Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) after one dose of booster vaccination of MenACYW conjugate vaccine
Time frame: at 18 MoA (up to Day 424)
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine.
Time frame: D91
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
pre-booster dose at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
Time frame: at 12 and 18 MoA (up to Day 484)
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA
pre-booster dose at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
Time frame: at 12 and 18 MoA (up to Day 484)
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
30 days (+10 days) post-booster vaccination at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
Time frame: 30 days after 12 and 18 MoA (up to Day 514)
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA
30 days (+10 days) post-booster vaccination at 12 and 18 MoA with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
Time frame: 30 days after 12 and 18 MoA (up to Day 514)
Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7).
Time frame: D151
Participants 2 MoA (Cohort III - Group 7): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 12 MoA (Group 7) with MenACYW conjugate vaccine
Time frame: at 12 MoA (up to Day 333)
Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 12 MoA (Group 7) with MenACYW conjugate vaccine
Time frame: at 12 MoA (up to Day 333)
Participants 2 MoA (Cohort III - Group 7): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine at 12 MoA (Group 7)
Time frame: 30 days after 12 MoA (up to Day 363)
Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine at 12 MoA (Group 7)
Time frame: 30 days after 12 MoA (up to Day 363)