NCT04127786

Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults

Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,708 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

The primary objective of this study is: To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42, ie. 14 days after the 3rd injection (for Primary Series Cohort 1). The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested To demonstrate that: * the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97% * VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28 * 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group * the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97% * 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1) To describe: * the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups * the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2) * the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2) * safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg

Detailed description

The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months. For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months.

Conditions

• Rabies
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Purified vero rabies vaccine - serum free - VRVg-2	Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
BIOLOGICAL	Purified inactivated rabies vaccine - Verorab®	Pharmaceutical form:Freeze-dried Route of administration: Intramuscular
BIOLOGICAL	Purified inactivated rabies vaccine - Imovax® Rabies	Pharmaceutical form: Freeze-dried Route of administration: Intramuscular

Timeline

• Start date: 2019-10-21
• Primary completion: 2020-03-25
• Completion: 2025-04-24
• First posted: 2019-10-16
• Last updated: 2026-02-10
• Results posted: 2024-02-09

Locations

4 sites across 1 country: Thailand

Regulatory

• FDA-regulated drug study