RABAVERT SUMMARY
RabAvert® Rabies Vaccine produced by Chiron Behring GmbH & Co KG is a sterile freeze-dried vaccine obtained by growing the fixed-virus strain Flury LEP in primary cultures of chicken fibroblasts.
RabAvert® is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.
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NEWS HIGHLIGHTS
Published Studies Related to Rabavert (Rabies Vaccine Flury LEP)
Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997-2005. [2007.05.22] On October 20, 1997, the U.S. Food and Drug Administration (FDA) licensed Purified Chick Embryo Cell (PCEC, RabAvert) vaccine against rabies in humans following clinical trials demonstrating safety and efficacy...
Clinical Trials Related to Rabavert (Rabies Vaccine Flury LEP)
Rabies Immune Plasma Booster Study [Completed]
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).
Phase I Pediatric FMP2.1/AS02A Trial in Mali [Completed]
The purpose of this study is to test the safety and dosages of a malaria vaccine in 100
children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine
when it is given to people who are regularly exposed to malaria and it will provide
information regarding optimal vaccine dosage. This study will compare 3 injections of
different vaccine doses to a rabies vaccine that is already approved. During the study, the
child's health will be checked in the clinic and during home visits. Children may
participate for about 14 months, and blood will be taken from each child throughout the
study. If the child becomes sick from malaria, he/she will be treated. Information from this
study may be used to develop a malaria vaccine that will help control the disease.
Study of Intradermal Administration of PCEC Rabies Vaccine [Completed]
Immunogenicity of Rabies Vaccine for Pre Exposure [Recruiting]
The purpose of this study is to compare the effectiveness of a two dose versus a three dose
schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children [Completed]
To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in
malaria-exposed children living in western Kenya and aged 12-47 months
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Page last updated: 2008-01-02
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