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Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland

NCT04594551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-09-19

No results posted yet for this study

Summary

Primary Objective:

To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.

Secondary Objective:

Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.

Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.

Conditions

  • Rabies (Healthy Volunteers)

Interventions

BIOLOGICAL

Purified vero rabies vaccine - serum free

Pharmaceutical form:freeze-dried - Route of administration: intramuscular

BIOLOGICAL

Purified inactivated rabies vaccine

Pharmaceutical form:freeze-dried - Route of administration: intramuscular

BIOLOGICAL

Human rabies immunoglobulins

Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2021-06-23
Completion
2021-06-23

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04594551 on ClinicalTrials.gov