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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729168
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Bharat Biotech International Limited
Information provided by (Responsible Party):
Le Hoang San, Pasteur Institute, Ho Chi Minh City

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rabies Biological: Human rabies vaccine Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arms and Interventions
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Arm Intervention/treatment
Experimental: Human rabies vaccines
Five doses 0.5 mL vaccine INDIRAB® on D0, D3, D7, D14, D28 using administered intramuscularly.
 Biological: Human rabies vaccine
Other Name: INDIRAB®


Outcome Measures
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Primary Outcome Measures :
  1. Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general). [ Time Frame: 30 minutes after vaccination ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729168


Locations
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Vietnam
Cho Gao Health Centre
Cho Gao, Tien Giang, Vietnam
Sponsors and Collaborators
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Bharat Biotech International Limited
More Information
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Responsible Party: Le Hoang San, Principal Investigator, Pasteur Institute, Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT02729168    
Other Study ID Numbers: VX-2015.01
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Le Hoang San, Pasteur Institute, Ho Chi Minh City:
Rabies
Vaccine
Safety
INDIRAB
Vietnam
Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases