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NCT02991872

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

Completed Phase 4 Last updated 12 April 2017
What this trial tests

Phase 4 trial testing Blood draw in Virus Diseases in 150 participants. Completed in 12 March 2017.

Timeline
16 December 2016
Primary endpoint
12 March 2017
12 March 2017

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment150
Start date16 December 2016
Primary completion12 March 2017
Estimated completion12 March 2017
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 10 to 22, any sex, with Virus Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Blood draw

Trials testing the same drug.

Other recruiting trials for Virus Diseases

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

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