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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.

NCT02545517 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2024-07-18

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 GSK Clinical Study Register is no longer maintained for this study.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

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).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-05
Primary Completion
2022-12-23
Completion
2022-12-23

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Entities

Companies

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 NCT02545517 on ClinicalTrials.gov