A parallel-group, prevention, Phase III, modified double-blind, 2-arm, study to investigate the immunogenicity and describe the safety of a quadrivalent meningococcal conjugate vaccine (MenACYW conjugate vaccine) compared with Nimenrix® when administered in a 1+1 schedule in healthy infants and toddlers at 6 and 12 months of age

Conditions

Healthy volunteers (Meningococcal infection)

Brief summary

Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y, Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA

Detailed description

hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W, and Y, hSBA antibody titers against meningococcal serogroups A, C, W, and Y, hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y, Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA, hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse, Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y, rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y, Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA, rSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse, Number of participants with immediate adverse events (AEs), Number of participants with solicited injection site reactions or systemic reactions, Number of participants with unsolicited AEs, Number of participants with serious adverse events (SAEs)

Related papers

No related papers found yet.

Interventions

DRUGNimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A

DRUGC

DRUGW-135 and Y conjugate vaccine

DRUGMenQuadfi solution for injection Meningococcal Group A

DRUGW and Y conjugate vaccine

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y, Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA	—

Secondary

Measure	Time frame
hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W, and Y, hSBA antibody titers against meningococcal serogroups A, C, W, and Y, hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y, Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA, hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse, Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y, rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y, Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA, rSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse, Number of participants with immediate adverse events (AEs), Number of participants with solicited injection site reactions or systemic reactions, Number of participants with unsolicited AEs, Number of participants wi	—

Measure

Time frame

hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W, and Y, hSBA antibody titers against meningococcal serogroups A, C, W, and Y, hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y, Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA, hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse, Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y, rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W, and Y, Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA, rSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse, Number of participants with immediate adverse events (AEs), Number of participants with solicited injection site reactions or systemic reactions, Number of participants with unsolicited AEs, Number of participants wi

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Countries

Czechia, Denmark, Finland, Germany, Poland, Romania

Outcome results

None listed