RabiesPhase 2NCT00703521
Rabies Immunization Concomitant With JEV in Children
A Phase 2 study testing Rabies vaccine in people with Rabies, run by Mahidol University.
Trial summary
Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option. Methods. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Sep 2005
- Phase
- Phase 2
- 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female 12-18 months old toddlers will be included in the study if they;
- are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
- are available for all the visits scheduled in the study;
- have been granted a written informed consent signed by their parents
Who cannot join
- a history of rabies immunization;
- a history of Japanese encephalitis immunization or disease;
- a significant acute or chronic infectious disease at the time of enrollment;
- fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
- being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;
- administration of any vaccine within the past 14 days before enrollment;
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- known immunodeficiency or an autoimmune disease;
- known hypersensitivity to neomycin, tetracycline, amphotericin-B;
- planned surgery during the study period;
- being enrolled in any other investigational trial contemporaneously;
- the family plans to leave the area of the study site before the end of study period;
- history of febrile convulsions;
- history of wheezing
About this study
Official title: A Three-Year Clinical Study on Immunogenicity, Safety and Booster Response of Purified Chick Embryo Cell Rabies Vaccine (Pcecv) Administered Intramuscularly or Intradermally to 12- to 18-Month-Old Thai Children Concomitantly With Japanese Encephalitis Vaccine
Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option.
Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).
- Conditions
- Rabies
- Being tested
- Rabies vaccine
- Keywords
- rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody, Antibody response, immunologic memory of rabies vaccination, Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes
- 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
1.0 mL IM day 0,7,28 and 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1,2,3,4,5 | Placebo comparator | 1. Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year
2. Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year
3. Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year
4. Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year
5. Japanese encephalitis vaccine 0.25 mL subcutaneous Receives: Biological: Rabies vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startAug 2002
- Primary completionOct 2002
- Study completionSep 2005
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiron company: Clinical Research and Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703521
- Sponsor's protocol ID
- M49P2
- Status last verified
- Jun 2008
- First submitted
- 20 Jun 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Year Clinical Study on Immunogenicity, Safety and Booster Response of Purified Chick Embryo Cell Rabies Vaccine (Pcecv) Administered Intramuscularly or Intradermally to 12- to 18-Month-Old Thai Children Concomitantly With Japanese Encephalitis Vaccine
- ClinicalTrials.gov ID
- NCT00703521
- Acronym / sponsor ID
- M49P2
- Conditions
- Rabies
- Keywords
- rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody, Antibody response, immunologic memory of rabies vaccination, Safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Chiron company: Clinical Research and Medical Affairs
- Study start
- Aug 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 23 Jun 2008 (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.
Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries. Including PreP in national childhood immunization programs (EPI) is a viable option.
Methods. In an open-label phase II clinical trial, 200 healthy toddlers were randomized to receive Purified Chick Embryo Cell Vaccine (PCECV) in a 3-dose Full-IM (1mL), Half-IM (0.5mL), 3-ID (0.1mL), or a 2-dose 2-ID (0.1mL) regimen, all in combination with two doses of Japanese Encephalitis (JEV), or JEV alone. One booster dose of PCECV (IM or ID) and JEV, or JEV alone was administered concomitantly one year after primary vaccination. Safety was evaluated after each injection. Blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. All sera were analyzed for rabies and JE virus neutralizing antibodies (RVNA, JEVNA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1,2,3,4,5 | Placebo comparator | Biological: Rabies vaccine1. Rabies vaccine 1.0 mL IM on day 0, 7, 28,and 1 year 2. Rabies vaccine 0.5 mL IM on day 0, 7, 28,and 1 year 3. Rabies vaccine 0.1 mL Intradermal on day 0, 7, 28,and 1 year 4. Rabies vaccine 0.1 mL Intradermal on day 0, 28,and 1 year 5. Japanese encephalitis vaccine 0.25 mL subcutaneous |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female 12-18 months old toddlers will be included in the study if they;
- are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
- are available for all the visits scheduled in the study;
- have been granted a written informed consent signed by their parents
Key exclusion criteria (13 listed)
- a history of rabies immunization;
- a history of Japanese encephalitis immunization or disease;
- a significant acute or chronic infectious disease at the time of enrollment;
- fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
- being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment;
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 vaccine1.0 mL IM day 0,7,28 and 1 year | Biological | 1,2,3,4,5 |
Primary outcome
Not reported in the source record.
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 24 Oct 2008.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rabies vaccine in people with Rabies, run by Mahidol University.
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 13 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 24 Oct 2008. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 24 Oct 2008.