Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age

Sanofi Pasteur, a Sanofi Company29 个研究点分布在 3 个国家目标入组 707 人开始时间: 2019年9月12日最近更新: 2025年9月15日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 707
试验地点: 29
主要终点: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary Objective:

To demonstrate:

the non-inferiority of the seroprotection rate (antibody titers greater than or equal to [>=] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then
the non-inferiority of the antibody response (geometric mean titers [GMT]). If this non-inferiority was demonstrated, then
the superiority of the antibody response (GMT). If this superiority was demonstrated, then
the superiority of the seroprotection rate.

Or to demonstrate:

the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then
the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
the superiority of the antibody response (GMT).

Secondary Objective:

To demonstrate:

the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then
the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
the superiority of the antibody response (GMT).

Or to demonstrate:

the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then
the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
the superiority of the antibody response (GMT) .

详细描述

Study duration per participant was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events up to 30 days after vaccination, serious adverse events and adverse event of special interest throughout the study.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Modified double-blind: the participant (or legally acceptable representative), and the Investigator remained unaware of the treatment assignments throughout the study. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.

入排标准

年龄范围: 12 Months 至 23 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Group 1: MenACYW Conjugate Vaccine

Experimental

Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.

干预措施: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine (Biological)

Group 2: Nimenrix® Vaccine

Active Comparator

Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.

干预措施: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine (Biological)

Group 3: NeisVac-C® Vaccine

Active Comparator

Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.

干预措施: Meningococcal group C polysaccharide Conjugate vaccine adsorbed (Biological)

结局指标

主要结局

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)