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| ID | Type | Description | Link |
|---|---|---|---|
| CVIA 071 | Other Identifier | PATH |
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| Name | Class |
|---|---|
| PATH | OTHER |
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This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra.
A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata).
Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NmCV-5 | Experimental | Subjects in this arm will receive polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. A single dose of 0.5 mL will be administered intramuscularly. |
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| Menactra | Active Comparator | Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. A single dose of 0.5 mL will be administered intramuscularly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NmCV-5 | Biological | Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroresponse | Percentage of subjects with seroresponse, measured by rabbit complement serum bactericidal activity (rSBA) against serogroups A, C, Y, W and X. [Seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the subject's pre-immunization (Day 1) rSBA titer was < 8; or a ≥ four-fold increase over baseline at Day 29 post-immunization if the subject's pre-immunization (Day 1) rSBA titer was ≥ 8]. | 28 Days post vaccination |
| Geometric mean titres | Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29 | 28 Days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited adverse events | Solicited AEs for 7 days following vaccination | 7 days post vaccination |
| Unsolicited adverse events | Unsolicited AEs for 28 days following vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 | Bamako | BP251 | Mali | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30120069 | Background | Chen WH, Neuzil KM, Boyce CR, Pasetti MF, Reymann MK, Martellet L, Hosken N, LaForce FM, Dhere RM, Pisal SS, Chaudhari A, Kulkarni PS, Borrow R, Findlow H, Brown V, McDonough ML, Dally L, Alderson MR. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6. Epub 2018 Aug 14. | |
| 37256992 |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000717934 | NmCV-5 vaccine |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Observer blind
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| Menactra | Biological | Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine |
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| 28 days post vaccination |
| Serious adverse events (SAEs) | SAEs for 6 months following vaccination | 6 months post vaccination |
| Seroprotective rSBA titres | Percentage of subjects with rSBA titer of ≥ 8 against serogroups A, C, Y, W, and X at Day 1 and Day 29 | 28 days post vaccination |
| Long term protective rSBA titres | Percentage of subjects with rSBA titer of ≥ 128 against serogroups A, C, Y, W, and X at Day 1 and Day 29 | 28 days post vaccination |
| Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine |
| Fajara |
| The Gambia |
| Derived |
| Castilla J, Cenoz MG, Barricarte A. Meningococcal Group B Vaccine (4CMenB) in Children. Reply. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available. |
| 37256991 | Derived | Lopez-Lacort M, Munoz-Quiles C, Orrico-Sanchez A. Meningococcal Group B Vaccine (4CMenB) in Children. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available. |
| 37224196 | Derived | Haidara FC, Umesi A, Sow SO, Ochoge M, Diallo F, Imam A, Traore Y, Affleck L, Doumbia MF, Daffeh B, Kodio M, Wariri O, Traore A, Jallow E, Kampmann B, Kapse D, Kulkarni PS, Mallya A, Goel S, Sharma P, Sarma AD, Avalaskar N, LaForce FM, Alderson MR, Naficy A, Lamola S, Tang Y, Martellet L, Hosken N, Simeonidis E, Welsch JA, Tapia MD, Clarke E. Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia. N Engl J Med. 2023 May 25;388(21):1942-1955. doi: 10.1056/NEJMoa2214924. |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |