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| ID | Type | Description | Link |
|---|---|---|---|
| V49_24E1 | Other Identifier | Novartis |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V49_24E1 Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Day-1/Visit-1 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mengshan | 546700 | China |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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