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A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children

NCT02991872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-04-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the long-term persistence of immune responses approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in 2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the subset of subjects who participated in the parent study (V49\_24 \[NCT01680016\]) who were aged ≥6 and ≤17 years at the time of enrollment.

This study is aimed to respond to a post-marketing commitment by the China Food and Drug Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo cell rabies vaccine license in China, granted in August 2015.

Conditions

  • Virus Diseases

Interventions

PROCEDURE

Blood draw

Subjects aged from ≥6 to ≤17 years at the time of enrolment in the parent clinical trial (following the CFDA post-marketing commitment requirement) and who received the full PEP rabies regimen as an intramuscular injection according to the vaccine group to which they were assigned in the V49\_24 (NCT01680016) study will be invited to take part in this study. Single blood draw from subjects at Day-1/Visit-1. Subjects will be observed for 15 minutes after the blood draw.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2017-03-12
Completion
2017-03-12

Countries

  • China

Study Locations

More Related Trials

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 NCT02991872 on ClinicalTrials.gov