NCT02177032已完成3 期
Phase 3, Randomized, Stratified, Open Label, Multicenter, Controlled Clinical Study to Evaluate Safety and Immunogenicity of a Rabies Vaccine Administered, With and Without Human Rabies Immunoglobulin, Using the New "4-sites, 1-week" Intradermal Regimen for Postexposure Prophylaxis Compared to the Currently Recommended "2-sites, TRC" Intradermal Regimen in Children and Adults Subjects.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 885
- 试验地点
- 11
- 主要终点
- Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)
研究概览
简要总结
Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females ≥ 1 years of age
- •Individuals/ individual's parents or legal guardians who have given written consent
- •Individuals in good health
- •Individuals who can comply with study procedures
排除标准
- •Behavioral or cognitive impairment or psychiatric disease.
- •Unable to comprehend and to follow all required study procedures for the whole period of the study.
- •History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
- •Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
- •Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
- •Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
- •Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
- •Female of childbearing potential, refusal to use an "acceptable birth control method" through day
- •Female of childbearing potential, with a positive pregnancy test prior to enrollment.
- •Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
- •Allergic to any of the vaccine components.
- •Allergic to any of the human rabies immunoglobulin components.
- •Contraindication or precaution against rabies vaccination.
- •Contraindication or precaution against man rabies immunoglobulin administration.
- •Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day
- •Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- •Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
- •Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
- •Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
- •Part of the study personnel or immediate family members of study personnel conducting this study.
- •Current or history of drug or alcohol abuse within the past 2 years.
结局指标
主要结局
Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)
时间窗: Study day 50 (D50)
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
次要结局
- Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination(From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen))
- Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age(At Days 8, 15, 91, 181 and 366)
- Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age(At Days 8, 15, 50, 91, 181 and 366)
- Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age(At Days 8, 15, 50, 91, 181 and 366)
- Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs(Study Day 50)
- Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age(At Days 8, 15, 91, 181 and 366)
- Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age(At Days 8, 15, 50, 91, 181 and 366)
- Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age(At Days 8, 15, 50, 91, 181 and 366)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(Day 1 to Day 366)
- Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age(At Days 8, 15,50, 91, 181 and 366)
研究者
研究点 (11)
Loading locations...
相似试验
招募中
3 期
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of AgeChickenpoxNCT06740630GlaxoSmithKline1,840
已完成
3 期
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV VaccinesHepatitis BNCT00366366GlaxoSmithKline150
已完成
3 期
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult ParticipantsHealthyNCT02543268Crucell Holland BV329
已完成
3 期
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years OldRespiratory Syncytial Virus PreventionNCT05083585Janssen Vaccines & Prevention B.V.250
已完成
3 期
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy ToddlersMeningococcal MeningitisMeaslesMumpsRubellaVaricellaNCT00384397Sanofi Pasteur, a Sanofi Company1,128