Rabies Clinical Trial
Official title:
A Bridging Study to Evaluate Safety of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 5 Years Old
An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.
The trial is a bridging study to evaluate safety of Rabies vaccine INDIRAB® Five Doses (0.5
ml) post exposure administered Intramuscularly in healthy Vietnamese Volunteer Aged from 5
years old. 120 subjects will be enrolled in Cho Gao district, Tien Giang province, in which
there are 100 adults (≥15 years old) and 20 children (5-<15 years old). These subjects will
be received 5 doses (0.5ml) INDIRAB® on D0, 3, 7, 14 and 28.
The frequency, rate and severity of immediate adverse events (AE) within 30 minutes after
vaccination, solicited and unsolicited AE within 7 days after each vaccination, the
frequency and rate of serious adverse events (SAE) within 35 days after the first
vaccination will be recorded as evidences for INDIRAB® safety assessment. The subjects to be
included from this trial would be representative of the population of Vietnam.
The protocol has been reviewed and approved by Institutional Review Board of Pasteur
Institute in Ho Chi Minh City and Vietnam Ministry of Health - Independent Ethics Committee
and Vietnam Minister of Health.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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