临床试验/NCT01086969

NCT01086969已完成3 期

Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India

Sanofi3 个研究点分布在 1 个国家目标入组 300 人开始时间: 2010年6月最近更新: 2012年2月6日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi
入组人数: 300
试验地点: 3
主要终点: Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination

研究概览研究设计入排标准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

The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.

Primary Objectives:

To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.
To describe the safety profile of participants after one dose of Menactra®.

详细描述

Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 2 Years 至 55 Years（Child, Adult）
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

结局指标

主要结局

Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination

时间窗: Baseline and 21 days post-vaccination

Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.

Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination

时间窗: Day 0 and Day 30 post-vaccination

Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.

Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination

时间窗: Day 0 to 30 post-vaccination

Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination

时间窗: Day 0 to 7 post-vaccination

Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia

次要结局

未报告次要终点

研究者

发起方

Sanofi

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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