Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly
|ClinicalTrials.gov Identifier: NCT02729168|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rabies||Biological: Human rabies vaccine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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®
- Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general). [ Time Frame: 30 minutes after vaccination ]
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729168
|Cho Gao Health Centre|
|Cho Gao, Tien Giang, Vietnam|