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Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally

Rabies Clinical Trial

Official title:
A Cross-over, Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S on Healthy Vietnamese Volunteers With 3 Doses of Pre-exposure Prophylaxis

Clinical Trial Summary

Randomized, open-label, prospective, before-and-after comparison study in the same group. Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of administration: Intramuscular or Intramuscular. Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28. The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose regimen in healthy volunteers.

Clinical Trial Description

1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone). Pre-exposure prophylaxis regimens for two groups - Intramuscular 1ml on days D0, D7 and D21-28 - Intradermal injection 0.1 ml on days D0, D7 and D21-28 Randomization was performed according to two age stratifications: - Stratification of research subjects from 5-15 years old - Stratification of research subjects from 16-60 years old Population selected research subjects in the community in Dong Hung district, Thai Binh province ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05937113
Study type Interventional
Source Vietnam Military Medical University
Contact
Status Completed
Phase Phase 4
Start date June 13, 2020
Completion date October 30, 2020
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