A Study to Evaluate the One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens in Chinese Children

ID: NCT03192371
Status: Withdrawn
Phase: Phase 4
Start Date: February 15, 2018
First Submitted: June 16, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: GlaxoSmithKline
Sponsors & Collaborators: GlaxoSmithKline
Location: N/A
Conditions: Virus Diseases
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Study Description

Brief Summary

The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.

Detailed Description

The clinical basis for the last renewal of the Rabipur license in China was the results from study V49_24 (NCT01680016), an immunogenicity and safety trial conducted in Chinese children (6 to 17 years) and adults (≥51 years), which confirmed the non-inferior immunogenicity of the Zagreb versus the conventional Essen post exposure prophylaxis intramuscular (PEP IM) regimen at Day 15 for both age groups.

At the time of license renewal in 2015, the Chinese health authorities requested that GSK continue to conduct immunogenicity persistence follow-ups for at least 1 year to compare the Zagreb regimen with the Essen regimen in populations under 17 years old.

V49_24E1 is an extension study to meet this request, in which subjects aged 17 years or younger who were immunized in the parent trial V49_24 will be recalled for a blood immunogenicity analysis approximately 4-5 years after the original vaccination.
Condition or disease Intervention/treatment Phase

Virus Diseases

Biological: Rabipur
Other Names
Rabies Vaccine (Chicken Embryo Cell) for Human use
Phase 4

Tracking Information

First Submitted DateJune 16, 2017
Last Update Posted DateFebruary 22, 2018
Anticipated Start DateFebruary 15, 2018
Anticipated Completion DateMay 12, 2019
Anticipated Primary Completion DateMay 12, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • All Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to subject withdrawal. [Time Frame: From Day1/Visit 1 through Day 393/Visit 11 (study termination).]

    Only SAEs and unsolicited AEs leading to study withdrawal will be collected. SAEs to be assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity, result in congenital anomaly/or birth defect or significant medical event that may not be immediately life threatening or resulting in death or hospitalization but may jeopardize the subject or require intervention to prevent one of the other outcomes listed. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject and/or parent(s)/legal guardian(s).

  • Percentage of subjects with RVNA concentrations ≥ 0.5 IU/mL [Time Frame: Study days 1, 15, 43, 197 and 393.]

    Comparison between Zagreb and Essen groups will be reported in terms of difference between percentages of subjects with RVNA concentrations ≥ 0.5 IU/mL.

  • Evaluation of immunogenicity in terms of antibody concentrations. [Time Frame: Study days 1, 15, 43, 197 and 393.]

    Immunogenicity is assessed in terms of Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Antibody (RVNA) concentrations. Comparison between Zagreb and Essen groups will be reported in terms of difference between GMCs.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study to Evaluate the One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens in Chinese Children
Official TitleA Phase IV, Randomized, Open-label Study to Evaluate One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese Children
Brief Summary

The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.

Detailed Description

The clinical basis for the last renewal of the Rabipur license in China was the results from study V49_24 (NCT01680016), an immunogenicity and safety trial conducted in Chinese children (6 to 17 years) and adults (≥51 years), which confirmed the non-inferior immunogenicity of the Zagreb versus the conventional Essen post exposure prophylaxis intramuscular (PEP IM) regimen at Day 15 for both age groups.

At the time of license renewal in 2015, the Chinese health authorities requested that GSK continue to conduct immunogenicity persistence follow-ups for at least 1 year to compare the Zagreb regimen with the Essen regimen in populations under 17 years old.

V49_24E1 is an extension study to meet this request, in which subjects aged 17 years or younger who were immunized in the parent trial V49_24 will be recalled for a blood immunogenicity analysis approximately 4-5 years after the original vaccination.

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
0
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Prevention
Conditions
Virus Diseases
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: Rabipur

Rabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years.

Other Names
Rabies Vaccine (Chicken Embryo Cell) for Human use
Study Groups/Cohorts
Zagreb 2-1-1 Group
4 doses of Rabipur vaccine, administered intramuscularly according to the Zagreb (2-1-1) regimen (i.e., 2 doses of vaccine administered on Day 1 and 1 dose of vaccine administered on Days 8 and 22).

Essen 1-1-1-1-1 Group
5 doses of Rabipur vaccine, administered intramuscularly according to the Essen (1-1-1-1-1) regimen (i.e., 1 dose of vaccine administered on Days 1, 4, 8, 15, and 29).

Study Arms
Experimental Essen 1-1-1-1-1 Group
5 doses of Rabipur vaccine, administered intramuscularly according to the Essen (1-1-1-1-1) regimen (i.e., 1 dose of vaccine administered on Days 1, 4, 8, 15, and 29).
Biological : Rabipur
Rabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years.

Experimental Zagreb 2-1-1 Group
4 doses of Rabipur vaccine, administered intramuscularly according to the Zagreb (2-1-1) regimen (i.e., 2 doses of vaccine administered on Day 1 and 1 dose of vaccine administered on Days 8 and 22).
Biological : Rabipur
Rabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years.

Arm Intervention/Treatment
Experimental Essen 1-1-1-1-1 Group
5 doses of Rabipur vaccine, administered intramuscularly according to the Essen (1-1-1-1-1) regimen (i.e., 1 dose of vaccine administered on Days 1, 4, 8, 15, and 29).
Biological : Rabipur
Experimental Zagreb 2-1-1 Group
4 doses of Rabipur vaccine, administered intramuscularly according to the Zagreb (2-1-1) regimen (i.e., 2 doses of vaccine administered on Day 1 and 1 dose of vaccine administered on Days 8 and 22).
Biological : Rabipur

Recruitment Information

Recruitment Status:Withdrawn
Enrollment0
Completion DateMay 12, 2019
Eligibility Criteria: Inclusion Criteria:
1. Individuals of 6 through 17 years of age on the day of informed consent/assent.
2. Individuals who are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator.
3. Individuals who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent on behalf of their child, and adolescents who have provided written assent, after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
4. Individuals who can comply with study procedures and are available for the duration of follow-up.

Exclusion Criteria:
1. A body temperature ≥38°C (axillary) within 3 days of intended study vaccination.
2. Known hypersensitivity to gentamycin, known allergies to excipients of Rabipur such as Polygeline, chicken protein, egg products or any other vaccine component.
3. Previously received any rabies vaccine or rabies immune globulin.
4. Subjects currently receiving or planning to receive antimalarial medications 4 days prior to V1/Day 1 vaccination and until the final vaccination.
5. Progressive, unstable or uncontrolled clinical conditions.
6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
7. 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.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Received immunoglobulins or any blood products within 180 days prior to informed consent.
9. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
10. Study personnel as an immediate family or household member.
11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
12. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
13. Children in care: A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
14. If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" for the duration of the study.
GenderAll
Age6 Years to 17 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03192371
Other Study ID Numbers
205854
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
GlaxoSmithKline
Collaborators
Not Available
Investigators
Study Director
GSK Clinical Trials
GlaxoSmithKline