An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of V221 Given Concomitantly With Pneumococcal Conjugate Vaccine in Healthy Children 12 to 15 Months of Age

Merck Sharp & Dohme LLC0 个研究点目标入组 1,027 人开始时间: 2006年3月最近更新: 2017年4月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 1,027
主要终点: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.

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: None

入排标准

年龄范围: 12 Months 至 15 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•In good health
•12 to 15 months of age
•Negative clinical history to measles, mumps, rubella, varicella and/or zoster
•Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
•Signed consent

排除标准

•Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
•Any condition resulting in depressed immunity
•Any allergy to any vaccine component as stated in the package circulars
•Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
•History of seizure disorder
•Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
•Recent febrile illness

结局指标

主要结局

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL

时间窗: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<255 mIU/mL) to Measles at Baseline.

Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL

时间窗: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 ELISA Ab units/mL) to Mumps at Baseline.

Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer

时间窗: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.

Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B

Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL

时间窗: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone

Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline.

Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer