RabiesNCT02729168
Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly
A study testing Human rabies vaccine in people with Rabies, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Human rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
An open label, non-comparative bridging study to evaluate the safety of Rabies vaccine INDIRAB® in Healthy Vietnamese volunteer aged from 5 years old.
Read the 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.
- Conditions
- Rabies
- Being tested
- Human rabies vaccine
- Keywords
- Rabies, Vaccine, Safety, INDIRAB, Vietnam
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human rabies vaccineBiological
Also called INDIRAB®
| Study group | Role | What they receive |
|---|---|---|
| Human rabies vaccines | Experimental | Five doses 0.5 mL vaccine INDIRAB® on D0, D3, D7, D14, D28 using administered intramuscularly. Receives: Biological: Human rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general).
Measured: 30 minutes after vaccination
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of solicited and unsolicited adverse events.
Measured: For 7 days after each vaccination
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of Serious Adverse Events.
Measured: Within 35 days after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
- Sponsor type
- University, hospital or other
- Collaborators
- Bharat Biotech International Limited
- Responsible party
- Principal investigator, Le Hoang San, Pasteur Institute, Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729168
- Sponsor's protocol ID
- VX-2015.01
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2016
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02729168
- Acronym / sponsor ID
- VX-2015.01
- Conditions
- Rabies
- Keywords
- Rabies, Vaccine, Safety, INDIRAB, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological ProductsUniversity, hospital or other
- Collaborators
- Bharat Biotech International Limited
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human rabies vaccines | Experimental | Biological: Human rabies vaccineFive doses 0.5 mL vaccine INDIRAB® on D0, D3, D7, D14, D28 using administered intramuscularly. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human rabies vaccineAlso: INDIRAB® | Biological | Human rabies vaccines |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human rabies vaccine in people with Rabies, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of rabies vaccine INDIRAB® by assessing the frequency, rate and severity of adverse events (local and general). (time frame: 30 minutes after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.