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Rabies clinical trials

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NCT ID: NCT01339312 Completed - Rabies Clinical Trials

Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine

Start date: April 2011
Phase: Phase 3
Study type: Interventional

This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations. Primary Objective: - To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over. Secondary Objectives: - To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall - To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.

NCT ID: NCT01286493 Completed - HIV Clinical Trials

Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

Start date: February 2011
Phase: N/A
Study type: Interventional

Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

NCT ID: NCT01228383 Completed - Rabies Clinical Trials

Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults

Start date: December 2011
Phase: Phase 2
Study type: Interventional

Study design: Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study Study objectives: Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects. Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).

NCT ID: NCT01137045 Completed - Rabies Clinical Trials

Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG

Start date: June 2010
Phase: Phase 4
Study type: Interventional

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

NCT ID: NCT01107275 Completed - Rabies Prevention Clinical Trials

Early Rabies Vaccine Immunization in Primary School Children

I49P1
Start date: November 2002
Phase: Phase 3
Study type: Interventional

700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.

NCT ID: NCT01063140 Completed - Rabies Clinical Trials

Rabies Immune Plasma Booster Study

Start date: January 2009
Phase: Phase 4
Study type: Observational

Rabies immune globulin is a product that is lifesaving to unvaccinated individuals exposed to the rabies virus. Rabies immune globulin is made from plasma from immune donors. Currently the only practical method to obtain this plasma is to immunize normal volunteer Source Plasma donors and collect their plasma while titers are adequate. The use of rabies vaccine for immunization of normal Source Plasma donors is currently limited to a level that, while protective for the individual, is unsuitable for production of rabies immune globulin. The objective of this study is to obtain efficacy and safety data regarding the rabies boostering program to demonstrate that: 1. Rabies immune plasma production can be substantially increased by giving booster doses to previously immunized donors whose titers are below 10.0 IU/mL. 2. It is safe for normal Source Plasma donors to receive booster doses of rabies vaccine on a regular basis. This study utilizes two rabies vaccines approved by the FDA, Imovax® (Sanofi-Pasteur) and RabAvert® (Novartis).

NCT ID: NCT01044199 Completed - Rabies Prevention Clinical Trials

Study of Intradermal Administration of PCEC Rabies Vaccine

Rabies-ID
Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine immunogenicity and safety of intradermal administration of the PCEC rabies vaccine in adults.

NCT ID: NCT00948272 Completed - Rabies Clinical Trials

Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration. Primary Objective: - To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series. Secondary Objectives: - To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects. - To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.

NCT ID: NCT00825305 Completed - Rabies Clinical Trials

Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)

Start date: November 2008
Phase: Phase 3
Study type: Interventional

This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China

NCT ID: NCT00708084 Completed - Rabies Clinical Trials

Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents

Start date: May 2008
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.