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

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.

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Key information

Conditions

Virus Diseases Infections

Age range

10 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site

Mengshan, 546700, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with age ≥ 6 and ≤17 at the time of enrollment in the parent study who signed the informed consent prior to the extension study entry, who received the full PEP in the parent study according to either the Zagreb or Essen intramuscular regimens.
Subjects who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent for this extension study after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures.

Exclusion criteria

Prior to extension study entry, each subject must not have:

Documented medical history of exposure to rabies or rabies prophylaxis after completion of the parent study (V49_24 [NCT01680016]) and before study start.
Participated in the parent study (V49_24 [NCT01680016]) but not received the full PEP vaccination course (or received it out of window) following assignment to either Zagreb or Essen regimen during the parent study.
Progressive, unstable or uncontrolled clinical conditions.
Clinical conditions representing a contraindication to blood draws.
Abnormal function of the immune system resulting from:

Clinical conditions.
Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent for all age groups.
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent for all age groups.
Received immunoglobulins or any blood products within 180 days prior to informed consent for all age groups.
Study personnel as an immediate family or household member.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Treatment and study plan

Blood draw

Procedure

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.

Primary outcomes

Rabies Virus Neutralizing Antibody(RVNA) GMCs as measured by rapid fluorescent focus inhibition test(RFFIT) measured in the study, following the Post-Exposure Prophylaxis(PEP) received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).

Time frame: Day-1/Visit-1
Percentage of subjects with RVNA concentration ≥ 0.5 IU/mL measured in this study, following the PEP received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).

Time frame: Day-1/Visit-1

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase IV, Open Label, Single-center Extension Study, to Evaluate the Long-term Persistence of Immune Responses After Post-exposure Prophylaxis With Purified Chicken-embryo Cell Rabies Vaccine in Chinese Children

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 14, 2016
Registry last updated: Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed