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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

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ClinicalTrials.gov Identifier: NCT02991872
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Virus Diseases Procedure: Blood draw Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 16, 2016
Actual Primary Completion Date : March 12, 2017
Actual Study Completion Date : March 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
V49_24E1 Group
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.
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   10 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Individuals who can comply with study procedures.

Exclusion Criteria:

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

  1. Documented medical history of exposure to rabies or rabies prophylaxis after completion of the parent study (V49_24 [NCT01680016]) and before study start.
  2. 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.
  3. Progressive, unstable or uncontrolled clinical conditions.
  4. Clinical conditions representing a contraindication to blood draws.
  5. 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.
  6. Received immunoglobulins or any blood products within 180 days prior to informed consent for all age groups.
  7. Study personnel as an immediate family or household member.
  8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991872


Locations
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China
GSK Investigational Site
Mengshan, China, 546700
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02991872     History of Changes
Other Study ID Numbers: 205634
V49_24E1 ( Other Identifier: Novartis )
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by GlaxoSmithKline:
Persistence
Purified chicken-embryo cell rabies vaccine
Rabies Virus Neutralizing Antibody (RVNA)
Immunogenicity
Post-Exposure Prophylaxis (PEP)
Rabipur

Additional relevant MeSH terms:
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Rabies
Virus Diseases
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs