Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis
研究概览
简要总结
Primary Objective:
To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection.
Secondary Objective:
- To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
- To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer >= 0.5 IU/mL at Day 28 was at least 95 percent (%).
- To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).
详细描述
Study duration per participant was approximately 7 months including: 1 day of screening and vaccination, a total of 5 vaccine injections over a 28-day period, 1 safety-follow up visit at Day 42, 1 safety follow-up/end of study visit at Day 56 and a 6-month safety follow-up call after last vaccine administration.
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)
盲法说明
Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but was not involved in the immunogenicity and safety evaluations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
研究组 & 干预措施
Group 1: VRVg-2 + HRIG
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
干预措施: VRVg-2 (Biological)
Group 1: VRVg-2 + HRIG
Participants received 0.5 milliliters (mL) intramuscular (IM) injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
干预措施: Rabies immune globulin (human) (Biological)
Group 2: Verorab + HRIG
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
干预措施: Purified Inactivated Rabies Vaccine (Biological)
Group 2: Verorab + HRIG
Participants received 0.5 mL IM injection of Verorab on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
干预措施: Rabies immune globulin (human) (Biological)
Group 3: Imovax Rabies + HRIG
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
干预措施: Human Diploid Cell Vaccine (HDCV) (Biological)
Group 3: Imovax Rabies + HRIG
Participants received 1 mL IM injection of Imovax Rabies on Days 0, 3, 7, 14 and 28 along with HRIG injection at Day 0.
干预措施: Rabies immune globulin (human) (Biological)
Group 4: VRVg-2
Participants received 0.5 mL IM injection of VRVg-2 formulation on Days 0, 3, 7, 14 and 28.
干预措施: VRVg-2 (Biological)
结局指标
主要结局
Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titers Greater Than or Equal to (>=) 0.5 International Units Per Milliliter (IU/mL)-Non-Inferiority Analysis
时间窗: Day 28
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
次要结局
- Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus(Day 0 (pre-vaccination), Day 14, Day 28 and Day 42)
- Number of Participants With Solicited Injection Site Reactions(Within 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5))
- Number of Participants With Solicited Systemic Reactions(Up to 7 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5))
- Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization(Day 0 (pre-vaccination), Day 14, Day 28 and Day 42)
- Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])(Day 0 (pre-vaccination), Day 14, Day 28 and Day 42)
- Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL(Day 0 (pre-vaccination), Day 14, Day 28 and Day 42)
- Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers(Day 0 (pre-vaccination), Day 14, Day 28 and Day 42)
- Number of Participants With Immediate Unsolicited Adverse Events (AEs)(Within 30 minutes after any and each vaccination (Vaccination 1, 2, 3, 4 and 5))
- Number of Participants With Unsolicited Adverse Events(Up to 28 days after any and each vaccination (Vaccination 1, 2, 3, 4 and 5))
- Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)(From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 7))