E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027274 |
E.1.2 | Term | Meningococcal infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To describe the safety profile of MenACYW conjugate vaccine and the safety profiles of the control vaccines (ie, locally-licensed MenAC conjugate vaccines: Royal or Green Bamboo) |
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E.2.2 | Secondary objectives of the trial |
•To describe the antibody (AB) responses against meningococcal serogroups A,C,Y and W for MenACYW conjugate vaccine and against serogroups A and C for Green Bamboo's MenAC conjugate vaccine following the administration of a single dose of the corresponding vaccine in children and adolescents 7-17 years of age (Cohort I [Groups 1 and 2]) •To describe the AB responses against meningococcal serogroups A,C,Y and W for MenACYW conjugate vaccine and against serogroups A and C for Royal’s MenAC conjugate vaccine following the administration of a single dose of the corresponding vaccine in children 2-6 years of age (Cohort II [Groups 3 and 4]) •To describe the AB responses against meningococcal serogroups A,C,Y, and W for MenACYW conjugate vaccine and against serogroups A and C for Royal’s MenAC conjugate vaccine following the administration of a single dose of the corresponding vaccine in toddlers 12-23 months of age (Cohort III [Groups 5 and 6]) [See translation section for continuation] |
•To describe the AB responses against meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and against serogroups A and C for Royal’s MenAC conjugate vaccine following the administration of two doses of the corresponding vaccine in infants 6-11 months of age (1 month interval between doses) (Cohort IV [Groups 7 and 8]) •To describe the AB responses against meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and against serogroups A and C for Green Bamboo’s MenAC conjugate vaccine following the administration of three doses of the corresponding vaccine in infants 3-5 months of age (1 month interval between doses) (Cohort V [Groups 9 and 10]) •To describe the immunogenicity of MenACYW conjugate vaccine and the immunogenicity of the control vaccines (ie, locally-licensed MenAC conjugate vaccines: Royal or Green Bamboo) to meningococcal serogroups A, C, Y, and W before and 30 days after the administration of 1, 2, or 3 doses of the corresponding vaccine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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
For participants 12 through 17 years of age: A female participant is eligible to participate if she is not pregnant or breastfeeding |
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E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply: - History of meningococcal infection - History of Guillain-Barré syndrome - At high risk for meningococcal infection during the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any study vaccination 2. 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 3. Presence of solicited systemic reactions (pre-listed in the participant’s DC and CRF) up to 7 days after each and any study vaccination 4. Presence of unsolicited AEs up to 30 days after each and any study vaccination 5. Presence of SAEs, throughout the trial, ie, from Visit 1 (first vaccination) to 6 months after the last study vaccination |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. D1 (all participants), D31 (participants of 3 through 11 months of age), and D61 (participants of 3 through 5 months of age) 2. D1 to D8 (all participants), D31 to D38 (participants of 3 through 11 months of age), D61 to D68 (participants of 3 through 5 months of age) 3. D1 to D8 (all participants), D31 to D38 (participants of 3 through 11 months of age), D61 to D68 (participants of 3 through 5 months of age) 4. D1 to D31 (all participants), D31 to D61 (participants of 3 through 11 months of age), D61 to D91 (participants of 3 through 5 months of age) 5. D1 to D181 (participants from 12 months through 17 years of age), D1 to D211 (participants of 6 through 11 months of age), D1 to D241 (participants of 3 through 5 months of age) |
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E.5.2 | Secondary end point(s) |
1. 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) 2. 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) 3. 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) 4. 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) 5. 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) 6. 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 of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after one dose of Green Bamboo’s vaccine in Group 2 (participants 2 through 17 years of age; 1 dose of vaccine) 7. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after one dose of MenACYW conjugate vaccine in Group 3 and against meningococcal serogroups A and C measured by rSBA 30 days after one dose of Royal’s vaccine in Group 4 (participants 2 through 6 years of age, 1 dose of vaccine) 8. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after one dose of MenACYW conjugate vaccine in Group 5 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after one dose of Royal’s vaccine in Group 6 (participants 12 through 23 months of age, 1 dose of vaccine) 9. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after the last dose of MenACYW conjugate vaccine in Group 7 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after the last dose of Royal’s vaccine in Group 8 (participants 6 through 11 months of age, 2 doses of vaccine 30 days apart) 10. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after the last dose of MenACYW conjugate vaccine in Group 9 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after the last dose of Green Bamboo’s vaccine in Group 10 (participants 3 through 5 months of age, 3 doses of vaccine, 30 days apart) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. D1 and D31 2. D1 and D31 3. D1 and D31 4. D1 and D61 5. D1 and D91 6. D1 and D31 7. D1 and D31 8. D1 and D31 9. D1 and D61 10. D1 and D91 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Randomized, open-label, parallel design |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 10 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last contact of the last participant |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 11 |