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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT02956421 |
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Date of registration:
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03/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
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Scientific title:
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Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02956421 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Limin Wijaya |
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Address:
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Telephone:
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Email:
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Affiliation:
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Singapore General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures.
- Never received rabies vaccine before.
- Refrain from blood donation during the course of the study.
- Able to attend all scheduled visits and comply with all trial procedures.
Exclusion Criteria:
- For women who are pregnant and breast-feeding
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either
the trial vaccine or another vaccine
- History of allergies to the medicine (S), convulsions, epilepsy, mental illness and
brain disease and clear serious systemic reaction
- Known bleeding disorder or suspected impairment of immunologic function, or receipt
of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
- Donation of blood within the last 2 months or who have donated plasma within the last
14 days
- Patient with clinical signs of encephalitis
- Recipient of any vaccine in the 4 weeks preceding the first trial vaccination, except
for influenza vaccination
- Planned participation in another clinical trial during the present trial period
- Concomitant use or at high probability of expected concomitant use during the planned
study of medication such as immune suppressants, steroids, non-study vaccine or
similar substances
- Use of any investigational or non-registered drug or vaccine other than the study
vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use
during the study period.
- Administration of immunoglobulins and/or any blood products within 3 months prior to
the first dose of study vaccine or planned administration during the study period.
- History of allergic disease or reactions likely to be exacerbated by any component of
the study vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection.
- Uncontrolled acute or chronic, clinically significant pulmonary, cardiovascular,
hepatic or renal functional abnormality, as determined by medical history or physical
examination.
- Chronic administration of immuno-suppressants or other immune-modifying drugs within
3 months prior to the first vaccine dose.
- Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal
tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant
tumor
Age minimum:
21 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rabies
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Intervention(s)
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Biological: RABIPUR®
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Biological: PIKA rabies vaccine
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Primary Outcome(s)
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Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen
[Time Frame: 42 days]
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Identification of any adverse events for all the treatment groups
[Time Frame: 42 days]
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Secondary Outcome(s)
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Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
[Time Frame: Day 7]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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