Rabies Post-exposure ProphylaxisPhase 3NCT00345319
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)
A Phase 3 study testing rabies vaccine in people with Rabies Post-exposure Prophylaxis, run by Novartis Vaccines at 1 site in China.
Trial summary
Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Post-exposure Prophylaxis
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to May 2006
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- male and female healthy subjects aged 10-60 years old
Who cannot join
- history of rabies immunization
- previous exposure to a suspect rabid animal within the last 12 months
- any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days
- treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment
- known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
- known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Immunogenicity and Safety of Rabies Vaccine Given in a Post-exposure Prophylaxis Regimen to Healthy Children and Adults Aged 10-60 Years.
Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.
- Conditions
- Rabies Post-exposure Prophylaxis
- Being tested
- rabies vaccine
- Keywords
- rabies, vaccine, post-exposure prophylaxis
- 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
Administration of PCECV according to ESSEN regimen
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Biological: rabies vaccine |
| Group 2 | Active comparator | Not described Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum bactericidal activity
Measured: measured at day 14 and day 45 after first vaccination dose
Secondary outcomes (1)
solicited local and systemic reactions
Measured: within 6 days following vaccination and adverse events thought the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Post-exposure ProphylaxisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines - Information Services, Study chair, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345319
- Sponsor's protocol ID
- M49P7
- Status last verified
- Dec 2011
- First submitted
- 27 Jun 2006
- Last updated
- 14 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Immunogenicity and Safety of Rabies Vaccine Given in a Post-exposure Prophylaxis Regimen to Healthy Children and Adults Aged 10-60 Years.
- ClinicalTrials.gov ID
- NCT00345319
- Acronym / sponsor ID
- M49P7
- Conditions
- Rabies Post-exposure Prophylaxis
- Keywords
- rabies, vaccine, post-exposure prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 28 Jun 2006 (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.
Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: rabies vaccine |
| Group 2 | Active comparator | Biological: rabies vaccine |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- male and female healthy subjects aged 10-60 years old
Key exclusion criteria (6 listed)
- history of rabies immunization
- previous exposure to a suspect rabid animal within the last 12 months
- any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days
- treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment
- known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
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 vaccineAdministration of PCECV according to ESSEN regimen | Biological | Group 1, Group 2 |
Primary outcome
serum bactericidal activity
Time frame: measured at day 14 and day 45 after first vaccination dose
1 secondary outcome
solicited local and systemic reactions
Time frame: within 6 days following vaccination and adverse events thought the study
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 14 Dec 2011.
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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 - Information Services study chair
Novartis Vaccines & Diagnostics
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 Post-exposure Prophylaxis, run by Novartis Vaccines at 1 site in China.
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 1 inclusion and 6 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 14 Dec 2011. 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 China. 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?
serum bactericidal activity (time frame: measured at day 14 and day 45 after first vaccination dose). 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 14 Dec 2011.