Clinical trial NCT02729168: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rabies
Keywords: Rabies
Vaccine
Safety
INDIRAB
Vietnam
Lead sponsor: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Sponsor class: OTHER
Collaborators: name: Bharat Biotech International Limited
First posted: 2016-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).
timeFrame: 30 minutes after vaccination
measure: Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events.
timeFrame: For 7 days after each vaccination
measure: Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events.
timeFrame: Within 35 days after the first vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Cho Gao
country: Vietnam
facility: Cho Gao Health Centre
state: Tien Giang
Study officials:
References: