CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 459 enrolled
Drug / intervention
Rabipur +2 morebiological
Likely dose
Purified Chick-Embryo Cell Rabies Vaccine 1.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02545517
NCT02545517Phase 3Completed

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.

GlaxoSmithKline·interventional·Posted Sep 10, 2015·Updated Jul 18, 2024

In Brief

A Phase 3 clinical trial evaluating Rabipur, Blood sampling, and 1 other intervention for Virus Diseases and Rabies. Completed, enrolled 459 participants across 7 sites in 3 countries.

Detailed 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 GSK Clinical Study Register is no longer maintained for this study.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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 10, 2015
Enrollment StartOct 5, 2015
Primary CompletionDec 23, 2022
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 10.8 years ago

Interventions

Rabipurbiological

Participants in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm.

Blood samplingprocedure

Blood samples were drawn from all participants at Day 1 and then at subsequent year intervals from extension study Day 1 onwards.

Purified Chick-Embryo Cell Rabies Vaccinebiological

1 booster dose of 1.0 mL of Purified Chick-Embryo Cell Rabies Vaccine intramuscular (IM).