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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) Using the Zagreb Regimen as Simulated Rabies Post-exposure Prophylaxis in Healthy Adults in Thailand

NCT04594551•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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.

Detailed Description

The duration of each subject's participation in the study will be approximately 7 months (21 day-vaccination period followed by 6 months safety follow-up period).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged ≥ 18 years on the day of inclusion
•Able to attend all scheduled visits and to comply with all study procedures
•Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2s

Exclusion Criteria

•Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
•Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
•Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 7 (D90)
•Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine
•Bite by, or exposure to a potentially rabid animal in the previous 6 months without post-exposure prophylaxis
•Receipt of immune globulins, blood or blood-derived products in the past 3 months
•Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•At high risk for rabies exposure
•Known systemic hypersensitivity to any of the study/control vaccine components or to human rabies immunoglobulin (HRIG), or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
•Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
+9 more criteria

Locations (3)

Investigational site number 7640002

Bangkok, Thailand

Investigational site number 7640001

Bangkok, Thailand

Investigational site number 7640003

Bangkok, Thailand

Key Dates

Start Date

October 11, 2020

Primary Completion Date

June 23, 2021

Completion Date

June 23, 2021

Last Updated

September 19, 2025

Enrollment

201

ACTUAL participants

Conditions

Rabies (Healthy Volunteers)

Interventions

Purified vero rabies vaccine - serum free

BIOLOGICAL

Purified inactivated rabies vaccine

BIOLOGICAL

Human rabies immunoglobulins

BIOLOGICAL

Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.

NCT07455318

Rabies (Healthy Volunteers)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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