Dog BiteNCT02339896
Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children
An observational study of Dog Bite, run by Queen Saovabha Memorial Institute.
Trial summary
To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dog Bite
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jan 2016
- How long will I take part?
- 365 Days
- Phase
- Observational
- 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 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: recruit the patients from Rabies clinic of Queen Saovabha Memorial Institute, Thammasat Hospital, Charoen Krung Pracha Rak Hospital and HRM Princess Maha Chakri Sirindhorn Medical Center and all had experienced WHO category II or III exposure to suspected rabid animal. In patients with WHO category III have to receive a heterologous biological (ERIG or HRIG)
Who may be able to join
- they are 1-15 years healthy children
- give signed informed consent from their parents
- willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan.
Who cannot join
- they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy
- Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs
- person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded
- Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit
About this study
Official title: Observation an Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) With or Without Rabies Immunoglobulin in Children
To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children
Read the detailed description
post exposure rabies vaccination with modified Thai red cross intrademal regimen has been proven to be immunogenic and effection when using purified vero cell vaccine (PVRV) In present, new chromatographically purified vero cell rabies vaccine (SPEEDA), chromatography purifed vero cell derived rabies vaccine, is manufactured by the Liaoning Chengda Biotechnology is available This study has a goal to determine the immunogenicity of speeda when using with post exposure rabies intradermal vaccination with or without rabies immune globulin in children
- Conditions
- Dog Bite
- Being tested
- rabies vaccine
- Keywords
- rabies, modified TRC intradermal rabies vaccine, SPEEDA
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabies vaccineBiological
rabies vaccine 0.1 ml intradermal two site for 4 times
| Study group | Role | What they receive |
|---|---|---|
| WHO category 2 | Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times Receives: Biological: rabies vaccine | |
| WHO category 3 | Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times with ERIG Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the level of rabies neutralizing antibodies after using SPEEDA® with modified TRC-ID rabies with or without RIG and the safety of using SPEEDA® with modified TRC-ID rabies with or without RIG in children
Measured: 1 year 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startFeb 2014
- Primary completionMar 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dog BiteStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- Queen Saovabha Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyada Angsuwatcharakon, Queen Saovabha Memorial Institute
- Investigators
- Piyada Angsuwatcharakon, MD, Principal investigator, QSMI TRC society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339896
- Sponsor's protocol ID
- RC5704
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation an Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) With or Without Rabies Immunoglobulin in Children
- ClinicalTrials.gov ID
- NCT02339896
- Acronym / sponsor ID
- RC5704
- Conditions
- Dog Bite
- Keywords
- rabies, modified TRC intradermal rabies vaccine, SPEEDA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Queen Saovabha Memorial InstituteUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 16 Jan 2015 (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.
To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children
Detailed description
post exposure rabies vaccination with modified Thai red cross intrademal regimen has been proven to be immunogenic and effection when using purified vero cell vaccine (PVRV) In present, new chromatographically purified vero cell rabies vaccine (SPEEDA), chromatography purifed vero cell derived rabies vaccine, is manufactured by the Liaoning Chengda Biotechnology is available This study has a goal to determine the immunogenicity of speeda when using with post exposure rabies intradermal vaccination with or without rabies immune globulin in children
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 365 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO category 2 | – | Biological: rabies vaccineChildren patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times |
| WHO category 3 | – | Biological: rabies vaccineChildren patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times with ERIG |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- recruit the patients from Rabies clinic of Queen Saovabha Memorial Institute, Thammasat Hospital, Charoen Krung Pracha Rak Hospital and HRM Princess Maha Chakri Sirindhorn Medical Center and all had experienced WHO category II or III exposure to suspected rabid animal. In patients with WHO category III have to receive a heterologous biological (ERIG or HRIG)
Key inclusion criteria (3 listed)
- they are 1-15 years healthy children
- give signed informed consent from their parents
- willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan.
Key exclusion criteria (4 listed)
- they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy
- Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs
- person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded
- Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit
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 |
|---|---|---|
| rabies vaccinerabies vaccine 0.1 ml intradermal two site for 4 times | Biological | WHO category 2, WHO category 3 |
Primary outcome
determine the level of rabies neutralizing antibodies after using SPEEDA® with modified TRC-ID rabies with or without RIG and the safety of using SPEEDA® with modified TRC-ID rabies with or without RIG in children
Time frame: 1 year 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
Related trials for Dog Bite
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Rabies Post-exposure Prophylaxis, Rabies
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.
Piyada Angsuwatcharakon, MD principal investigator
QSMI TRC society
Questions about this trial
What is this clinical trial studying?
An observational study of Dog Bite, run by Queen Saovabha Memorial Institute.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
determine the level of rabies neutralizing antibodies after using SPEEDA® with modified TRC-ID rabies with or without RIG and the safety of using SPEEDA® with modified TRC-ID rabies with or without RIG in children (time frame: 1 year 6 month). 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 16 Jan 2015.