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临床试验/NCT02545517
NCT02545517已完成3 期

A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults Who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis With Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately From a Japanese Encephalitis Vaccine.

GlaxoSmithKline8 个研究点 分布在 3 个国家目标入组 459 人开始时间: 2015年10月5日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
459
试验地点
8
主要终点
Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6

研究概览

简要总结

The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM regimen.

This product has been transferred to BN. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on www.clinicaltrials.gov.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All individuals who were randomized to a Rabies primary series vaccination for pre-exposure prophylaxis (PrEP), received the full PrEP regimen and completed the parent trial following study protocol.

排除标准

  • Completed the parent study without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen.
  • History of exposure to suspected or confirmed rabid animal.
  • Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of the parent study

结局指标

主要结局

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 5 and Year 6

时间窗: Year 5 to Year 6 (after primary series of vaccination)

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 7 and Year 8

时间窗: Year 7 to Year 8 (after primary series of vaccination)

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 8

时间窗: At Year 8 after primary series of vaccine administration

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 4

时间窗: At Year 4 after primary series of vaccine administration

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 8 and Year 9

时间窗: Year 8 to Year 9 (after primary series of vaccination)

RVNA Antibody Concentrations 7 Days After the Booster Dose

时间窗: At Day 7 after booster dose

RVNA antibody concentrations were measured in terms of Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 6

时间窗: At Year 6 after primary series of vaccine administration

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 9

时间窗: At Year 9 after primary series of vaccine administration

RVNA Geometric Mean Ratios (GMRs) 7 Days After the Booster Dose Versus Antibody Concentrations Before the Booster Dose

时间窗: Day 7 after booster dose compared to baseline (7 days before booster dose)

GMR was calculated as ratio of post booster dose RVNA GMCs (7-day post booster dose) to the baseline RVNA GMCs (7 days before booster dose). The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 4 and Year 5

时间窗: Year 4 to Year 5 (after primary series of vaccination)

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 3

时间窗: At Year 3 after primary series of vaccine administration

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 7

时间窗: At Year 7 after primary series of vaccine administration

Number of Participants Reporting Serious Adverse Events (SAEs) After a Booster Dose of Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine

时间窗: From booster vaccination [6 to 9 months after Year 3 (3 years after primary series of vaccination)] up until completion of the safety follow-up period (10 years after primary series of vaccination)

A SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required/prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the participants or may require intervention to prevent one of the other outcomes listed. Safety is assessed as the number of participants reporting SAEs after a booster dose of PCEC rabies vaccine administered in this extension study, if RNVA concentrations were \<0.5 IU/mL, following a primary series of accelerated or conventional rabies pre-exposure (PrEP) intramuscular (IM) regimen in the parent study.

Number of Participants Who Had Their Rabies Virus Neutralizing Antibody (RNVA) Concentrations Drop Below 0.5 International Units (IU) Per Milliliter (mL) Between Day 366 and Year 3

时间窗: Day 366 to Year 3 (after primary series of vaccination)

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 3 and Year 4

时间窗: Year 3 to Year 4 (after primary series of vaccination)

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 6 and Year 7

时间窗: Year 6 to Year 7 (after primary series of vaccination)

Number of Participants Who Had Their RNVA Concentrations Drop Below 0.5 IU/mL Between Year 9 and Year 10

时间窗: Year 9 to Year 10 (after primary series of vaccination)

Percentage of Participants With RVNA Concentrations Greater Than or Equal to (>=) 0.5 IU/mL, 7 Days After Booster Dose

时间窗: At Day 7 after booster dose

The booster dose was administered in this Extension study (conducted from Year 3 to Year 9 after the primary schedule study) only when participants had RVNA concentrations \<0.5 IU/mL at the yearly immunogenicity check (i.e., at "Scheduled Clinic Visit"). Booster dose administration occurred at an approximate timepoint between 6 and 9 months from the previous "Scheduled Clinic Visit" during the Years 3 to 9.

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 5

时间窗: At Year 5 after primary series of vaccine administration

Percentage of Participants With RVNA Concentrations >= 0.5 IU/mL at Year 10

时间窗: At Year 10 after primary series of vaccine administration

次要结局

  • Rabies Virus Neutralizing Antibody Concentrations(At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration)
  • Reverse Cumulative Percentage for Participants With RVNA Concentrations >=0.5 IU/mL(At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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