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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02729168
Other study ID # VX-2015.01
Secondary ID
Status Completed
Phase N/A
First received March 25, 2016
Last updated March 31, 2016
Start date October 2015
Est. completion date December 2015

Study information

Verified date March 2016
Source Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

1. Healthy male or female aged from 5 years old. Women of childbearing age must use an appropriate method of contraception.

2. 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.

3. Subject who gave voluntary to comply with the study requirements.

Exclusion Criteria:

1. Subjects have atopic allergy or severe allergy to any component of vaccine.

2. Subjects with mental illness, mental retardation.

3. Subjects with severe acute or chronic disease may affect safety (eg: hepatobiliary disease, kidney disease, diabetes, hypertension…).

4. Subjects received rabies vaccine.

5. Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.

6. Subjects who received other vaccine within 28 days before INDIRAB® vaccination, or those who had another vaccination schedule during the study.

7. Pregnant or lactating women.

8. Subjects had been participated, are participating, are going to participate in any other clinical trials during the period of this study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Human rabies vaccine


Locations

Country Name City State
Vietnam Cho Gao Health Centre Cho Gao Tien Giang

Sponsors (2)

Lead Sponsor Collaborator
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products Bharat Biotech International Limited

Country where clinical trial is conducted

Vietnam, 

Outcome

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