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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

Primary Purpose

Virus Diseases

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Blood draw

About this trial

This is an interventional prevention trial for Virus Diseases focused on measuring Persistence, Purified chicken-embryo cell rabies vaccine, Rabies Virus Neutralizing Antibody (RVNA), Immunogenicity, Post-Exposure Prophylaxis (PEP), Rabipur

Eligibility Criteria

10 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:
1. Clinical conditions.
2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent for all age groups.
3. 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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

V49_24E1 Group

Arm Description

Up to 225 subjects, who completed the full PEP rabies regimens in the parent study V49_24 (NCT01680016), will be invited to participate to this extension study.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02991872

First Posted

December 9, 2016

Last Updated

April 10, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02991872

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

December 16, 2016 (Actual)

Primary Completion Date

March 12, 2017 (Actual)

Study Completion Date

March 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Virus Diseases

Keywords

Persistence, Purified chicken-embryo cell rabies vaccine, Rabies Virus Neutralizing Antibody (RVNA), Immunogenicity, Post-Exposure Prophylaxis (PEP), Rabipur

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V49_24E1 Group

Arm Type

Other

Arm Description

Up to 225 subjects, who completed the full PEP rabies regimens in the parent study V49_24 (NCT01680016), will be invited to participate to this extension study.

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

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 Outcome Measure Information:

Title

Time Frame

Day-1/Visit-1

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Mengshan

ZIP/Postal Code

546700

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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