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

NCT02729168 | Completed

• 1 other identifier: VX-2015.01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies

Keywords

Rabies; Vaccine; Safety; INDIRAB; Vietnam

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Human rabies vaccines

EXPERIMENTAL

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

Biological: Human rabies vaccine

Interventions

Human rabies vaccine BIOLOGICAL

Also known as: INDIRAB®

Human rabies vaccines

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products: lead
• Bharat Biotech International Limited: collaborator

Study Sites (1)

Cho Gao Health Centre

Chợ Gạo, Tien Giang, Vietnam

Location

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: April 6, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-03

Locations

VN (1)