NCT02545517

A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.

A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults Who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis With Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately From a Japanese Encephalitis Vaccine.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies PrEP IM regimen. This product has been transferred to BN. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on www.clinicaltrials.gov.

Conditions

• Virus Diseases
• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Rabipur	Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.
PROCEDURE	Blood sampling	Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards.
BIOLOGICAL	Purified Chick-Embryo Cell Rabies Vaccine	1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM).

Timeline

• Start date: 2015-10-05
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2015-09-10
• Last updated: 2024-07-18
• Results posted: 2024-07-18

Locations

7 sites across 3 countries: Austria, Germany, Switzerland