Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly

Study Overview
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Brief Summary
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An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.

Detailed Description
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The trial is a bridging study to evaluate safety of Rabies vaccine INDIRAB® Five Doses (0.5 ml) post exposure administered Intramuscularly in healthy Vietnamese Volunteer Aged from 5 years old. 120 subjects will be enrolled in Cho Gao district, Tien Giang province, in which there are 100 adults (≥15 years old) and 20 children (5-<15 years old). These subjects will be received 5 doses (0.5ml) INDIRAB® on D0, 3, 7, 14 and 28. The frequency, rate and severity of immediate adverse events (AE) within 30 minutes after vaccination, solicited and unsolicited AE within 7 days after each vaccination, the frequency and rate of serious adverse events (SAE) within 35 days after the first vaccination will be recorded as evidences for INDIRAB® safety assessment. The subjects to be included from this trial would be representative of the population of Vietnam. The protocol has been reviewed and approved by Institutional Review Board of Pasteur Institute in Ho Chi Minh City and Vietnam Ministry of Health - Independent Ethics Committee and Vietnam Minister of Health.

Official Title
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A Bridging Study to Evaluate Safety of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 5 Years Old

Conditions
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Rabies

Intervention / Treatment
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* Biological: Human rabies vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female aged from 5 years old. Women of childbearing age must use an appropriate method of contraception. Subjects had sign written consent form to participate in the study. With subjects aged from 5 to below 18 years old, parents/legal representative had sign written consent form for children to participate in this study. Subject who gave voluntary to comply with the study requirements. Exclusion Criteria: Subjects have atopic allergy or severe allergy to any component of vaccine. Subjects with mental illness, mental retardation. Subjects with severe acute or chronic disease may affect safety (eg: hepatobiliary disease, kidney disease, diabetes, hypertension…). Subjects received rabies vaccine. Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection. Subjects who received other vaccine within 28 days before INDIRAB® vaccination, or those who had another vaccination schedule during the study. Pregnant or lactating women. Subjects had been participated, are participating, are going to participate in any other clinical trials during the period of this study.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human rabies vaccines<br>Five doses 0.5 mL vaccine INDIRAB® on D0, D3, D7, D14, D28 using administered intramuscularly. | Biological: Human rabies vaccine<br> <br> * Other names: INDIRAB®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general). |  | 30 minutes after vaccination | 
| Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events. |  | For 7 days after each vaccination | 
| Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events. |  | Within 35 days after the first vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rabies, Vaccine, Safety, INDIRAB, Vietnam