A Phase 2b, Randomized, Observer-Blinded Trial to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Participants ≥11 to <15 Years of Age

Conditions

Meningitis, Meningococcal

Brief summary

The percentages of participants with hSBA titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains at - baseline (Day 1 [Month 0]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group)., The%of participants with solicited administration site and systemic events during the 7 days following each vaccination at Day 1, Day 721,and Day 1441.The % of participants with any unsolicited AEs including all SAEs, AEs leading to withdrawal,AESIs and medically attended AEs during the 30 days following each vaccination at Day 1,Day 721,and Day 1441.The % of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs during the 6 months following the first vaccination

Detailed description

The percentages of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y at - baseline (Day 1 [Month 0]), - 1 month after the first dose of MenABCWY (Day 31 [Month 1]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group).

Related papers

No related papers found yet.

Interventions

DRUGNaCl 0.9% solution

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The percentages of participants with hSBA titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains at - baseline (Day 1 [Month 0]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group)., The%of participants with solicited administration site and systemic events during the 7 days following each vaccination at Day 1, Day 721,and Day 1441.The % of participants with any unsolicited AEs including all SAEs, AEs leading to withdrawal,AESIs and medically attended AEs during the 30 days following each vaccination at Day 1,Day 721,and Day 1441.The % of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs during the 6 months following the first vaccination	—

Measure

Time frame

The percentages of participants with hSBA titers ≥ lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains at - baseline (Day 1 [Month 0]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group)., The%of participants with solicited administration site and systemic events during the 7 days following each vaccination at Day 1, Day 721,and Day 1441.The % of participants with any unsolicited AEs including all SAEs, AEs leading to withdrawal,AESIs and medically attended AEs during the 30 days following each vaccination at Day 1,Day 721,and Day 1441.The % of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs during the 6 months following the first vaccination

—

Secondary

Measure	Time frame
The percentages of participants with hSBA titers ≥ LLOQ for N. meningitidis serogroups A, C, W and Y at - baseline (Day 1 [Month 0]), - 1 month after the first dose of MenABCWY (Day 31 [Month 1]) and, - 1 month after the second dose of MenABCWY (Day 751 [Month 25]) for the ABCWY-24 group and Day 1471 [Month 49] for the ABCWY-48 group).	—

Countries

Germany

Outcome results

None listed