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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1256-8979 | Registry Identifier | ICTRP |
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This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
The duration of each participant's participation will be approximately 180 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 MenACYW1-dose schedule | Experimental | 1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age |
|
| Group 2 MenACYW135 Ps 1-dose schedule | Active Comparator | 1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age |
|
| Group 3 MenACYW1-dose schedule | Experimental | 1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age |
|
| Group 4 Royal MenAC1-dose schedule | Active Comparator | 1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACYW conjugate vaccine | Biological | Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W | 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W | Antibodies titers are expressed as geometric mean titers | Day 31 (post- vaccination) |
| Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine | 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C | 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C | Antibody titers are expressed as geometric mean titers |
| Measure | Description | Time Frame |
|---|---|---|
| Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1) | 30 days post 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 vaccination for participants with pre vaccination rSBA titer ≥1:8 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
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Inclusion Criteria:
Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 1561000 | Nanning | Guangxi | 530028 | China | ||
| Investigational Site Number : 1561001 |
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| Label | URL |
|---|---|
| MEQ00076 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Investigators and study staff as well as Sponsor study staff who conduct the safety assessment and the participant/parent/LAR will not know which study intervention is administered. Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered.
|
| MenACYW135 polysaccharide vaccine | Biological | Pharmaceutical form: Lyophilized powder-Route of administration:IM injection |
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| MenAC conjugate vaccine | Biological | Pharmaceutical form:Lyophilized powder-Route of administration:IM injection |
|
| Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine | 30 days post-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-vaccination for participants with pre vaccination rSBA titer ≥1:8 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Number of participants with immediate adverse events (AEs) | Unsolicited systemic AEs that occur within 30 minutes after vaccination | Within 30 minutes post-vaccination |
| Presence of solicited injection site reactions | Solicited injection site reactions include injection site pain, erythema and swelling | Within 7 days post-vaccination |
| Presence of solicited systemic reactions | Solicited systemic reactions include fever, headache, malaise and myalgia | Within 7 days post-vaccination |
| Presence of unsolicited AEs | Within 30 days post-vaccination |
| Presence of SAEs | SAEs, including adverse events of special interest (AESIs), reported throughout the study | Up to Day 181 post-vaccination |
| Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2 | Antibody titers measured by rSBA titer ≥1:8, ≥1:128 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4 | Antibody titers measured by rSBA titer ≥1:8, ≥1:128 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3 | Antibodies titers are expressed as geometric mean titers | Day 01 (pre-vaccination) and Day 31 (post- vaccination) |
| Jingxi |
| 533899 |
| China |
| Investigational Site Number : 1561003 | Liuzhou | 545100 | China |
| Investigational Site Number : 1561002 | Tengzhou | 543399 | China |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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