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Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adult and Pediatric Population in Thaïland

NCT04478084 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

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 vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) and Day 42 (to assess the immune response after 4 doses \[2-2-2-0-2\]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults.

Secondary Objectives:

* To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) when co-administered with ERIG (Group 3 and Group 4) at Day 0 in healthy adults
* To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess the immune response 90 days post-rabies simulated exposure) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults
* To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and Group 6) at Day 0 in adults, after each vaccination.

Conditions

  • Rabies (Healthy Volunteers)

Interventions

BIOLOGICAL

Purified vero rabies vaccine - serum free VRVg-2

Pharmaceutical form:freeze-dried Route of administration: intradermal

BIOLOGICAL

Purified inactivated rabies vaccine

Pharmaceutical form:freeze-dried Route of administration: intradermal

BIOLOGICAL

Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)

Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular

BIOLOGICAL

Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)

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
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2022-03-19
Completion
2022-07-21

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 NCT04478084 on ClinicalTrials.gov