A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,412
- 主要终点
- Geometric Mean Titer (GMT) of Measles Virus Antibodies
研究概览
简要总结
This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process
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)
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
- •Negative clinical history for measles, mumps, rubella, varicella, and zoster
排除标准
- •Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
- •Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
- •Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
- •Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
- •Received 1) systemic immunomodulatory steroids [greater than the
- •equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to
- •entering the study, or 2) any dose of systemic immunomodulatory steroids within
- •7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
- •History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
- •Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
- •Diagnosis of an active neurological disorder. Enrollment may be considered
- •when the disease process has been stabilized
- •History of seizure disorder, including single febrile seizure
- •Diagnosis of active untreated tuberculosis
- •History of thrombocytopenia
- •Born to a human immunodeficiency virus (HIV) infected mother
研究组 & 干预措施
MMRV (AMP)
Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
干预措施: MMRV (AMP) (Biological)
MMRV (2006 process)
Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process
干预措施: MMRV (2006 process) (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Measles Virus Antibodies
时间窗: Six weeks after vaccination 1
Sera were tested for measles virus IgG antibody levels by ELISA
Geometric Mean Titer (GMT) of VZV Antibodies
时间窗: Six weeks after vaccination 1
Sera were tested for VZV IgG antibody levels by gpELISA
Geometric Mean Titer (GMT) of Mumps Virus Antibodies
时间窗: Six weeks after vaccination 1
Sera were tested for mumps virus IgG antibody levels by ELISA
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
时间窗: Six weeks after vaccination 1
Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
时间窗: Six weeks after vaccination 1
Sera were tested for measles virus IgG antibody levels by an ELISA
Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
时间窗: Six weeks after vaccination 1
Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
Geometric Mean Titer (GMT) of Rubella Virus Antibodies
时间窗: Six weeks after vaccination 1
Sera were tested for rubella virus IgG antibody levels by ELISA
Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
时间窗: Six weeks after vaccination 1
Sera were tested for rubella virus IgG antibody levels by an ELISA
Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
时间窗: Up to 5 days after vaccination 1
次要结局
- Percentage of Participants With Measles-like Rash(Up to 42 days after each vaccination)
- Percentage of Participants With Varicella-like Rash(Up to 42 days after each vaccination)
- Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)(Up to 42 days after each vaccination)
- Percentage of Participants With Mumps-like Symptoms(Up to 42 days after each vaccination)
- Percentage of Participants With Zoster-like Rash(Up to 42 days after each vaccination)
- Percentage of Participants With an Injection-site Adverse Event(Up to 5 days after each vaccination)
- Percentage of Participants With Rubella-like Rash(Up to 42 days after each vaccination)