Rabies PreventionPhase 3I49P1NCT01107275
Early Rabies Vaccine Immunization in Primary School Children
A Phase 3 study testing rabies vaccine in people with Rabies Prevention, run by Provincial Public Health Office, Phetchabun at 1 site in Thailand.
Trial summary
700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Prevention
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2002to Nov 2008
- Phase
- Phase 3
- 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 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female 5-8 years old school children will be included in the study if:
- Their parents or legal guardians have given the written informed consent prior to study entry;
- They are in good health at time of study entry as determined by medical history, physical examination and clinical judgment of the investigator;
- They are available for all the visits scheduled in the study.
Who cannot join
- Subjects are not to be enrolled into the study if:
- They have a history of rabies immunization;
- They have an acute infectious disease at the time of study entry;
- They are under treatment with parenteral and/or oral steroids, immunosuppressive drugs, phenytoin or other specific anti-inflammatory drugs, or have taken chloroquine during the two month period before enrolment;
- They have a known immunodeficiency or an autoimmune disease;
- They have a known hypersensitivity to neomycin, tetracycline or amphotericin-B;
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- They have planned surgery during the first study period (49 days);
- They are participating in any other trial of an investigational agent;
- They have any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- The family plans to leave the area of the study site before the end of the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare Immunogenicity, Safety and Long-term Booster Response After Primary Vaccination With 2 Intradermal Doses Versus 3 Intradermal Doses of PCEC Rabies Vaccine (Rabipur) in Healthy School Children in Thailand (5-8 Years of Age)
700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.
- Conditions
- Rabies Prevention
- Being tested
- rabies vaccine
- Keywords
- Rabies, PCECV, pre-exposure immunization, intradermal, children
- 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
Also called PCECV, Rabipur
intradermal vaccination
| Study group | Role | What they receive |
|---|---|---|
| 2 primary ID doses | Experimental | two doses of rabies vaccines given intradermally on days 0 and 28 Receives: Biological: rabies vaccine |
| 3 primary ID doses | Experimental | three doses of rabies vaccines given intradermally on days 0, 7, and 28 Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
rabies virus neuralizing antibody, assessed by RFFIT
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Measured: seven days after the first booster dose
Secondary outcomes (2)
rabies virus neuralizing antibody, assessed by RFFIT
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Measured: one year after the first booster dose
rabies virus neuralizing antibody, assessed by RFFIT
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
Measured: immediately before administration of the first booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startNov 2002
- Primary completionNov 2004
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rabies PreventionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provincial Public Health Office, Phetchabun
- Sponsor type
- Other government
- Investigators
- Thavatchai Kamoltham, MD, Principal investigator, Provincial PHO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107275
- Sponsor's protocol ID
- I49P1
- Acronym
- I49P1
- Status last verified
- Apr 2010
- First submitted
- 16 Apr 2010
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kamoltham T, Thinyounyong W, Phongchamnaphai P, Phraisuwan P, Khawplod P, Banzhoff A, Malerczyk C. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe. J Pediatr. 2007 Aug;151(2):173-7. doi: 10.1016/j.jpeds.2007.02.044.
PubMed 17643772
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Immunogenicity, Safety and Long-term Booster Response After Primary Vaccination With 2 Intradermal Doses Versus 3 Intradermal Doses of PCEC Rabies Vaccine (Rabipur) in Healthy School Children in Thailand (5-8 Years of Age)
- ClinicalTrials.gov ID
- NCT01107275
- Acronym / sponsor ID
- I49P1 / I49P1
- Conditions
- Rabies Prevention
- Keywords
- Rabies, PCECV, pre-exposure immunization, intradermal, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Provincial Public Health Office, PhetchabunOther government
- Study start
- Nov 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Apr 2010 (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.
700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 primary ID doses | Experimental | Biological: rabies vaccinetwo doses of rabies vaccines given intradermally on days 0 and 28 |
| 3 primary ID doses | Experimental | Biological: rabies vaccinethree doses of rabies vaccines given intradermally on days 0, 7, and 28 |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their parents or legal guardians have given the written informed consent prior to study entry;
- They are in good health at time of study entry as determined by medical history, physical examination and clinical judgment of the investigator;
- They are available for all the visits scheduled in the study.
Key exclusion criteria (10 listed)
- They have a history of rabies immunization;
- They have an acute infectious disease at the time of study entry;
- They are under treatment with parenteral and/or oral steroids, immunosuppressive drugs, phenytoin or other specific anti-inflammatory drugs, or have taken chloroquine during the two month period before enrolment;
- They have a known immunodeficiency or an autoimmune disease;
- They have a known hypersensitivity to neomycin, tetracycline or amphotericin-B;
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 vaccineAlso: PCECV, Rabipurintradermal vaccination | Biological | 2 primary ID doses, 3 primary ID doses |
Primary outcome
rabies virus neuralizing antibody, assessed by RFFIT
Time frame: seven days after the first booster dose
rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT)
2 secondary outcomes
rabies virus neuralizing antibody, assessed by RFFIT
Time frame: one year after the first booster dose
rabies virus neuralizing antibody, assessed by RFFIT
Time frame: immediately before administration of the first booster dose
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 20 Apr 2010.
- Results publication: PubMed 17643772Kamoltham T, Thinyounyong W, Phongchamnaphai P, Phraisuwan P, Khawplod P, Banzhoff A, Malerczyk C. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe. J Pediatr. 2007 Aug;151(2):173-7. doi: 10.1016/j.jpeds.2007.02.044.
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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.
Thavatchai Kamoltham, MD principal investigator
Provincial PHO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rabies vaccine in people with Rabies Prevention, run by Provincial Public Health Office, Phetchabun at 1 site in Thailand.
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 4 inclusion and 10 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 20 Apr 2010. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
rabies virus neuralizing antibody, assessed by RFFIT (time frame: seven days after the first booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107275, which also lists 1 linked publication.
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 20 Apr 2010.