Dataset Information

A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix^® Vaccine When Given to Healthy Infants at 3 and 12 Months of Age.

ABSTRACT:

Introduction

Infants and young children typically have the highest age-related risk of invasive meningococcal disease. The immunogenicity and safety of a single primary dose and a booster of a meningococcal A/C/W/Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix^®) in infants were evaluated.

Methods

In this phase 3b, open-label, single-arm study, healthy 3-month-old infants received a single Nimenrix dose followed by a booster at age 12 months (1 + 1 series). Functional antibodies before and 1 month after each vaccination were evaluated with serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement for each A/C/W/Y serogroup. Primary endpoints were rSBA seroprotection (titers ≥ 1:8) rates and geometric mean titers (GMTs); supportive s

SUBMITTER: Koski S

PROVIDER: S-EPMC11829884 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature

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Dataset Information

A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix^® Vaccine When Given to Healthy Infants at 3 and 12 Months of Age.

Introduction

Methods

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix® Vaccine When Given to Healthy Infants at 3 and 12 Months of Age.

Introduction

Methods

OmicsDI is part of the ELIXIR infrastructure

Tweets

A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix^® Vaccine When Given to Healthy Infants at 3 and 12 Months of Age.