Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) (NCT03964012) | Clinical Trial Compass
CompletedPhase 3
Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)
Mali, The Gambia1,800 participantsStarted 2019-08-20
Plain-language summary
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).
Who can participate
Age range2 Years – 29 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
✓. 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).
✓. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
✓. 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.
✓. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration
Exclusion criteria
✕. 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).
. 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).
✕. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
✕. Current or previous, confirmed disease caused by Neisseria meningitidis.
✕. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
✕. Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®).
✕. History of significant hypersensitivity reactions to any previous vaccine.
✕. 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.