Meningococcal infection
Conditions
Interventions
1 dose of MenACYW conjugate to participants aged 7 through 17 years of age:MenACYW conjugate
1 dose of Green Bamboo’s MenAC conjugate to participants aged 7 through 17 years of age:Green Bamboo’s MenAC conjugate
1 dose of MenACYW conjugate to participants aged 2 through 6 years of age:MenACYW conjugate
1 dose of Royal’s MenAC conjugate to participants aged 2 through 6 years of age:Royal’s MenAC conjugate
1 dose of MenACYW conjugate to participants aged 12 through 23 months of age:MenACYW conjugate
1 dose of Royal’s MenAC conjugate to participants aged 12 through 23 months of age:Royal’s MenAC conjugate
2 doses of MenACYW conjugate at 1 month interval to participants aged 6 through 11 months of age:MenACYW conjugate
2 doses of Royal’s MenAC conjugate at 1 month interval to participants aged 6 through 11 months of age:Royal’s MenAC conjugate
3 doses of MenACYW conjugate at 1 month interval to participants aged 3 through 5 months of age:MenACYW conjugate
3 doses of Green Bamboo’s MenAC conjugate at 1 month interval to participants aged 3 through 5 months of age:Green Bamboo’s MenAC conjugate
Sponsors
Center for Disease Control and Prevention of Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: 1. For participants 3 through 23 months of age: Born at full term of pregnancy (=37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the Investigator 2. For participants 12 through 17 years of age: A female participant is eligible to participate if she is not pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: 1. History of meningococcal infection 2. History of Guillain-Barré syndrome 3. At high risk for meningococcal infection during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any study vaccination.;Presence of solicited injection site reactions (pre listed in the participant’s diary card [DC] and case report form [CRF]) up to 7 days after each and any study vaccination.;Presence of solicited systemic reactions (pre-listed in the participant’s DC and CRF) up to 7 days after each and any study vaccination.;Presence of unsolicited AEs up to 30 days after each and any study vaccination.;Presence of SAEs, throughout the trial, ie, from Visit 1 (first vaccination) to 6 months after the last study vaccination.;Antibody titers against meningococcal serogroups A, C, Y, and W in Group 9 and against meningococcal serogroups A and C in Group 10 measured by rSBA titer =1:8, =1:128on D91 (+7 days); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort I [Groups 1 and 2]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Green Bamboo’s MenAC conjugate vaccine measured using serum bactericidal assay using rabbit complement (rSBA) in serum specimens collected on D01 (pre-vaccination) and D31 (30 days [+7 days] after vaccination with the corresponding study vaccine);Cohort II [Groups 3 and 4]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Royal’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D31 (30 days [+7 days] after vaccination with the corresponding study vaccine);Cohort III [Groups 5 and 6]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Royal’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D31 (30 days [+7 days] after vaccination with the corresponding study vaccine);Cohort IV [Groups 7 and 8]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Royal’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D61 (30 days [+7 days]) after the second vaccination with the corresponding study vaccine);Cohort V [Groups 9 and 10]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Green Bamboo’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D91 (30 days [+7 days] after the third vaccination with the corresponding study vaccine);Antibody titers in terms of Geometric mean titers (GMT) against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after one dose of MenACYW conjugate vaccine in Group 1 and antibody titers in terms | — |
Countries
China
Contacts
Public ContactLiwei Shi
Center for Disease Control and Prevention of Guangxi Zhuang Autonomous Region
Outcome results
None listed