RabiesPhase 2NCT00694460
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
A Phase 2 study testing Three 1 mL doses of Rabies vaccine and two JE vaccine, Three 0.5 mL doses of Rabies vaccine and two JE vaccine and Three 0.1mL doses of Rabies Vaccine and two JE vaccine in people with Rabies and Japanese Encephalitis, run by Novartis at 1 site in Thailand.
Trial summary
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis
- What is being tested?
- Three 1 mL doses of Rabies vaccine and two JE vaccine, Three 0.5 mL doses of Rabies vaccine and two JE vaccine and Three 0.1mL doses of Rabies Vaccine and two JE vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2002to Sep 2004
- 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 if they
- are in good health at time of entry into the study
- 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°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
- being under treatment with 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
Show all 14Show fewer
- known immunodeficiency or an autoimmune disease
- history of allergy to eggs, egg products
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.
- Conditions
- Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis
- Being tested
- Three 1 mL doses of Rabies vaccine and two JE vaccine, Three 0.5 mL doses of Rabies vaccine and two JE vaccine, Three 0.1mL doses of Rabies Vaccine and two JE vaccine, Two 0.1mL doses of Rabies vaccine and two JE vaccine, Two doses of JE vaccine
- Keywords
- rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody
- Medical subject headings
- Rabies, Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three 1 mL doses of Rabies vaccine and two JE vaccineBiological
Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Three 0.5 mL doses of Rabies vaccine and two JE vaccineBiological
Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Three 0.1mL doses of Rabies Vaccine and two JE vaccineBiological
Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Two 0.1mL doses of Rabies vaccine and two JE vaccineBiological
Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses)
Two doses of JE vaccineBiological
Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine |
| 2 | Experimental | Not described Receives: Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine |
| 3 | Experimental | Not described Receives: Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine |
| 4 | Experimental | Not described Receives: Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine |
| 5 | Active comparator | Not described Receives: Biological: Two doses of JE vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies virus neutralizing antibody concentrations
Measured: 2 years
Secondary outcomes (1)
Japanese encephalitis virus neutralizing antibody titers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startAug 2002
- Primary completionAug 2004
- Study completionSep 2004
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 (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694460
- Sponsor's protocol ID
- M49P2
- Status last verified
- Jun 2008
- First submitted
- 30 May 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.
- ClinicalTrials.gov ID
- NCT00694460
- Acronym / sponsor ID
- M49P2
- Conditions
- Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis
- Keywords
- rabies vaccination, pre-exposure prophylaxis, rabies virus neutralizing antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Aug 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 10 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.
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Three 1 mL doses of Rabies vaccine and two JE vaccine |
| 2 | Experimental | Biological: Three 0.5 mL doses of Rabies vaccine and two JE vaccine |
| 3 | Experimental | Biological: Three 0.1mL doses of Rabies Vaccine and two JE vaccine |
| 4 | Experimental | Biological: Two 0.1mL doses of Rabies vaccine and two JE vaccine |
| 5 | Active comparator | Biological: Two doses of JE vaccine |
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 if they
- are in good health at time of entry into the study
- are available for all the visits scheduled in the study
- have been granted a written informed consent, signed by their parents
Key exclusion criteria (14 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°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
- being under treatment with 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 |
|---|---|---|
| Three 1 mL doses of Rabies vaccine and two JE vaccineVaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) | Biological | 1 |
| Three 0.5 mL doses of Rabies vaccine and two JE vaccineVaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) | Biological | 2 |
| Three 0.1mL doses of Rabies Vaccine and two JE vaccineVaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) | Biological | 3 |
| Two 0.1mL doses of Rabies vaccine and two JE vaccineVaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) | Biological | 4 |
| Two doses of JE vaccineVaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses) | Biological | 5 |
Primary outcome
Rabies virus neutralizing antibody concentrations
Time frame: 2 years
1 secondary outcome
Japanese encephalitis virus neutralizing antibody titers
Time frame: 2 years
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 10 Jun 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.
Novartis Vaccines study chair
Novartis Vaccines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Three 1 mL doses of Rabies vaccine and two JE vaccine, Three 0.5 mL doses of Rabies vaccine and two JE vaccine and Three 0.1mL doses of Rabies Vaccine and two JE vaccine in people with Rabies and Japanese Encephalitis, run by Novartis 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 14 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 10 Jun 2008. 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 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.
What does the primary outcome measure?
Rabies virus neutralizing antibody concentrations (time frame: 2 years). 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 10 Jun 2008.