Virus Diseases Clinical Trial
Official title:
A Phase IV, Randomized, Open-label Study to Evaluate One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese Children
The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.
The clinical basis for the last renewal of the Rabipur license in China was the results from
study V49_24 (NCT01680016), an immunogenicity and safety trial conducted in Chinese children
(6 to 17 years) and adults (≥51 years), which confirmed the non-inferior immunogenicity of
the Zagreb versus the conventional Essen post exposure prophylaxis intramuscular (PEP IM)
regimen at Day 15 for both age groups.
At the time of license renewal in 2015, the Chinese health authorities requested that GSK
continue to conduct immunogenicity persistence follow-ups for at least 1 year to compare the
Zagreb regimen with the Essen regimen in populations under 17 years old.
V49_24E1 is an extension study to meet this request, in which subjects aged 17 years or
younger who were immunized in the parent trial V49_24 will be recalled for a blood
immunogenicity analysis approximately 4-5 years after the original vaccination.
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