Meningococcal Meningitis
Conditions
Interventions
Polyvalent conjugated Meningococcal vaccine NmCV5
Sponsors
Serum Institute of India Pvt. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration. 2. Written informed consent obtained from subjects at least 18 years of age or from their parent/guardian for subjects less than 18 years of age with additional subject assent obtained as appropriate for participating community (i.e. subjects at least 13 years of age in Mali or at least 12 years of age in The Gambia). 3. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures. 4. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit. 5. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration
Exclusion criteria
Exclusion criteria: 1. Acute illness, at the time of study IP administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility). 2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study IP administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility). 3. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years. 4. Current or previous, confirmed disease caused by Neisseria meningitidis. 5. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration. 6. Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®). 7. History of significant hypersensitivity reactions to any previous vaccine. 8. Administration of any vaccine other than study IPs within 28 days prior to study IP administration or planned administration prior to completion of the study Day 29 visit. 9. Administration of any investigational drug within 30 days prior to study IP administration or planned administration during the study period. 10. Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure: 1. 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 postimmunization if the subject’s pre-immunization (Day 1) rSBA titer was = 8]. 2. Geometric mean titres Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Solicited adverse events Solicited AEs for 7 days following vaccination ;2. Unsolicited adverse events Unsolicited AEs for 28 days following vaccination;3. Solicited adverse events Solicited AEs for 7 days following vaccination 7 days post vaccination;4. Unsolicited adverse events Unsolicited AEs for 28 days following vaccination;5. Serious adverse events (SAEs) SAEs for 6 months following vaccination ;6. 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;7. 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 | — |
Countries
Gambia, Mali
Contacts
Public ContactPrasad Kulkarni
Medical Director
Outcome results
None listed