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Rabies clinical trials

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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.

NCT ID: NCT00703521 Completed - Rabies Clinical Trials

Rabies Immunization Concomitant With JEV in Children

Start date: August 2002
Phase: Phase 2
Study type: Interventional

Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option. Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).

NCT ID: NCT00694460 Completed - Rabies Clinical Trials

Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

Start date: August 2002
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.

NCT ID: NCT00656097 Completed - Rabies Clinical Trials

A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

Start date: March 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) or placebo in combination with rabies vaccine in healthy adult subjects.

NCT ID: NCT00345319 Completed - Clinical trials for Rabies Post-exposure Prophylaxis

Purified Rabies Vaccine for Human Use (Chick-embryo Cell)

Start date: March 2006
Phase: Phase 3
Study type: Interventional

Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.

NCT ID: NCT00260351 Completed - Rabies Clinical Trials

Immunogenicity and Safety of Verorabâ„¢ in Indian Population

Start date: December 2004
Phase: Phase 4
Study type: Interventional

- To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or, - To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure. Secondary objectives: 1. To describe the immunogenicity profile of each regimen 2. To assess the safety of the vaccine in each group.