Nervous System Diseases
Conditions
Sponsors
Eubiologics Co Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female participants with the age at time of study vaccination 2.Participant informed consent or assent and/or parent and/or legal guardian informed consent: a.Children = 17 years of age: Signed or fingerprinted or personally marked written informed consent obtained from parent and/or legal guardian b.Children = 12 years of age in The Gambia and = 13 years of age in Mali: Participant signed or fingerprinted or personally marked written informed assent c.Adults = 18 years of age: Signed or fingerprinted or personally marked written informed consent Note: Participants who turn 18 years of age during the study period, will be required to provide informed consent 3.Children who complete their local EPI schedule: a.A birth dose of OPV is not required b.Cohort 2: Through and including 9 months of age (no MenAfriVac® dose) c.Cohort 4: Through and prior to 15 months of age (no MenAfriVac® dose and no 15+ months EPIs) d.Cohort 5: Through and prior to 9 months of age (no MenAfriVac® dose and no 9+ months EPIs) 4.Healthy, as defined by the absence of any clinically significant medical conditions 5.Participant and/or parent and/or legal guardian of the participant resides in the study site area, with no intent to move out during the study period, and is able and willing to adhere to all protocol requirements 6.Participant must be either of non-childbearing potential or, if of childbearing potential, not breastfeeding and not pregnant and must have been practicing adequate contraception for = 2 months prior to study vaccination and agree to continue such precautions consistently through 2 months post study vaccination, as well as agree to not become pregnant through other means 7.Participant agrees not to enroll in another study of an investigational research agent
Exclusion criteria
Exclusion criteria: 1.Acute illness at the time of study vaccination 2.Recorded fever/use of an antipyretic medication within 48 hours prior to study vaccination 3.Cohorts 1 and 2: a. Abnormal safety laboratory test value for age b. Laboratory confirmed HIV, chronic hepatitis B virus infection, and/or hepatitis C virus infection 4.Current/previous N. meningitidis 5.Household contact/intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to Screening 6.Administration of systemic antibiotic treatment within 3 days of study vaccination 7.Administration of any vaccine other than the study vaccines within 28 days prior to/after study vaccination 8. Participation in another investigational product clinical study within 90 days prior to enrollment in this study/receipt of any such investigational product other than the study vaccines within 30 days prior to administration of study vaccines/planned use during study 9.Receipt of immunoglobulins and/or any blood products within 90 days prior to study vaccination/planned administration during study 10.Confirmed/suspected/family history immunodeficiency of congenital or hereditary immunodeficiency 11.Prior use of or anticipated need of long-acting immunomodulating drug/chronic administration of high dose systemic corticosteroids during study 12.History of severe adverse/allergic reaction to any vaccine or any components of the study vaccines 13.Participant is an employee/close personal relation of any person employed by the Sponsor, PATH, the CRO, the PI, key study site personnel 14.Planned surgery during the study period that would require hospitalization, use of prohibited medication, or will interfere with follow-up visits 15.History of known disturbance of coagulation/blood disorder 16.Medical/psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 17.Neurological disease/disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). ;Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination ;Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination ;Cohort 4 1. The percentage of participants with rSBA titers = 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination ;Cohort 5 1. The percentage of participants with rSBA titers = 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination ;Cohort 6 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination ;Cohort 1 1. Number and severity of solicited AEs for 7 days post-vaccination (Day 8). 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination (Day 29). 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination (Day 169). ;Cohort 2 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 336 days post-vaccination ;Cohort 3 1. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination ;Cohort 4 1. The percentage of participants with rSBA titers = 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination ;Cohort 5 1. The percentage of participants with rSBA titers = 1:8 against serogroups A, C, W, Y, and X at 28 days post-vaccination ;Cohort 6 1. Number and seve | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 4 1. Number and severity of solicited AEs for 7 days post-vaccination 2. Number, severity, and relatedness of unsolicited AEs for 28 days post-vaccination 3. Number, severity, and relatedness of SAEs for 168 days post-vaccination 4. Percentage of participants with seropositive response for measles at 28 days post-vaccination. The seropositive response to measles vaccine is defined as anti-measles IgG concentration = 200 mIU/mL. 5. Percentage of participants with seropositive response for rubella at 28 days post-vaccination. The seropositive response to rubella vaccine is defined as = 10 IU/mL. 6. GMTs of rSBA against serogroups A, C, W, Y, and X at 28 days post-vaccination. 7. Percentage of participants with rSBA titer of = 1:8 and = 1:128, respectively, against serogroups A, C, W, Y, and X at and at 28 days post-vaccination. Persistence outcomes 1.GMTs of rSBA against serogroups A, C, W, Y, and X in a subset of participants at 168 days post-vaccination (Day 169) in a subset of participants. 2. Percentage with rSBA titer of = 1:8 and = 1:128, respectively, against serogroups A, C, W, Y, and X at 168 days post-vaccination (Day 169) in a subset of participants. ;Cohort 1 1. GMTs of rSBA against serogroups A, C, W, Y, and X at BaselineA and 28 days post-vaccination 2. Percentage of participants with seroresponse measured by rSBA against serogroups A, C, W, Y, and X at 2 | — |
Countries
Gambia, Mali
Contacts
Public ContactNiles Eaton
Clinical Research Manager
Outcome results
None listed