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

Rabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729168
• Other study ID #: VX-2015.01
• 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

• Rabies

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