search
Back to results

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

Primary Purpose

Rabies

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Human rabies vaccine
Sponsored by
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies focused on measuring Rabies, Vaccine, Safety, INDIRAB, Vietnam

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cho Gao Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human rabies vaccines

Arm Description

Five doses 0.5 mL vaccine INDIRAB® on D0, D3, D7, D14, D28 using administered intramuscularly.

Outcomes

Primary Outcome Measures

Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events.
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2016
Last Updated
March 31, 2016
Sponsor
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Collaborators
Bharat Biotech International Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT02729168
Brief Title
Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Collaborators
Bharat Biotech International Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
Rabies, Vaccine, Safety, INDIRAB, Vietnam

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human rabies vaccines
Arm Type
Experimental
Arm Description
Five doses 0.5 mL vaccine INDIRAB® on D0, D3, D7, D14, D28 using administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Human rabies vaccine
Other Intervention Name(s)
INDIRAB®
Primary Outcome Measure Information:
Title
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).
Time Frame
30 minutes after vaccination
Title
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events.
Time Frame
For 7 days after each vaccination
Title
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events.
Time Frame
Within 35 days after the first vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Cho Gao Health Centre
City
Cho Gao
State/Province
Tien Giang
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs