NCT03239873已完成3 期
A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly With M-M-R™ II
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 74
- 主要终点
- Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
研究概览
简要总结
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX® (Varicella Virus Vaccine Live) manufactured with a new passage extension (PE34) process compared with the VARIVAX® 2016 commercial process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX® PE34 Process are non-inferior to those induced by VARIVAX® 2016 commercial process, and that antibody response rate induced by VARIVAX® PE34 Process is acceptable.
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
- Triple (Participant, Care Provider, Investigator)
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 varicella, herpes zoster, measles, mumps, and rubella
排除标准
- •Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
- •Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
- •Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
- •History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX® or M-M-R II®
- •Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
- •Received salicylates within 14 days prior to study vaccination
- •Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
- •Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
- •History of seizure disorder, including febrile seizure
- •Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
- •History of thrombocytopenia
- •Born to a human immunodeficiency virus (HIV)-infected mother
- •Has a diagnosis of active untreated tuberculosis
- •Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
结局指标
主要结局
Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
时间窗: 6 weeks (43 days) after vaccination 1
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers \<1.25 gpELISA units/mL) at baseline.
Geometric Mean Titer of VZV Antibodies
时间窗: 6 weeks (43 days) after vaccination 1
The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.
次要结局
- Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)(Up to 42 days after vaccination 1)
- Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)(6 weeks (~43 days) after vaccination 1)
- Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)(Up to 42 days after vaccination 1)
- Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)(Up to 42 days after vaccination 2)
- Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2(Up to 5 days after vaccination 2)
- Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody(Baseline and 6 weeks (~43 days) after vaccination 1)
- Percentage of Participants Who Discontinued From the Study Due to an Adverse Event(Up to 42 days after vaccination 1 and up to 42 days after vaccination 2)
- Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)(Up to 42 days after vaccination 2)
- Percentage of Participants With One or More Vaccine-Related Serious Adverse Events(Up to ~180 days after vaccination 2)
- Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)(Up to ~180 days after vaccination 2 (Up to ~285 days))
- Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)(Up to 42 days after vaccination 1; Up to 42 days after vaccination 2)
- Percentage of Participants With One or More Adverse Events(Up to 42 days after vaccination 1 and up to 42 days after vaccination 2)
- Percentage of Participants With One or More Vaccine-Related Adverse Events(Up to 42 days after vaccination 1 and up to 42 days after vaccination 2)
- Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)(Up to 42 days after vaccination 1)
- Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1(Up to 5 days after vaccination 1)
- Percentage of Participants With One or More Serious Adverse Events(Up to ~180 days after vaccination 2 (Up to ~285 days))
- Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody(Baseline and 6 weeks (~43 days) after vaccination 1)
- Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)(Up to 42 days after vaccination 2)
研究者
研究点 (74)
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