RabiesNCT01067079
Single Center, Open Label, Follow up Study in Subjects Who Previously Received Rabies Vaccine as Simulated Post-Exposure Regimen
An observational study of Rabies, run by Novartis Vaccines at 1 site in China.
Trial summary
This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- No vaccine administered; subjects only have blood sampling for immunogenicity
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Jan 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
Who may be able to join
- Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
Who cannot join
- Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study.
- Receipt of additional doses of rabies vaccine after completion of initial vaccine series.
- For additional entry criteria please refer to protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule
This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules
- Conditions
- Rabies
- Being tested
- No vaccine administered; subjects only have blood sampling for immunogenicity
- Keywords
- Rabies vaccine, Long-term Immunogenicity
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No vaccine administered; subjects only have blood sampling for immunogenicityOther
No vaccine administered; subjects only have blood sampling for
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Not described Receives: Other: No vaccine administered; subjects only have blood sampling for immunogenicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL
Measured: 13 months, 3 years and 5 years after initial vaccination
Secondary outcomes (1)
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration
Measured: 13months, 3 years and 5years after initial vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2010
- Study completionJan 2010
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067079
- Sponsor's protocol ID
- M49P8E1
- Status last verified
- Dec 2011
- First submitted
- 9 Feb 2010
- Last updated
- 30 Dec 2011
- Results posted
- No
Publications
Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773.
PubMed 25483635
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Single Center, Open Label, Follow-up Immunogenicity Study in Subjects Who Previously Received Post-exposure Rabies Vaccine According to the Essen or 2:1:1 (Zagreb) Schedule
- ClinicalTrials.gov ID
- NCT01067079
- Acronym / sponsor ID
- M49P8E1
- Conditions
- Rabies
- Keywords
- Rabies vaccine, Long-term Immunogenicity
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Feb 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.
This study will evaluate the immunogenicity of rabies vaccine at 13 months, 3 year and 5 years after initial vaccination, administered in two different post-exposure vaccination schedules
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: No vaccine administered; subjects only have blood sampling for immunogenicity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
Key inclusion criteria (1 listed)
- Male and Female subjects who received complete vaccine series in accordance to the designated vaccination schedule in the previous M49P8 study
Key exclusion criteria (3 listed)
- Any disease condition, that in the opinion of investigator may interfere with subjects ability to participate in the study.
- Receipt of additional doses of rabies vaccine after completion of initial vaccine series.
- For additional entry criteria please refer to protocol.
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 |
|---|---|---|
| No vaccine administered; subjects only have blood sampling for immunogenicityNo vaccine administered; subjects only have blood sampling for | Other | Arm 1 |
Primary outcome
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL
Time frame: 13 months, 3 years and 5 years after initial vaccination
1 secondary outcome
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by geometric mean concentration
Time frame: 13months, 3 years and 5years after initial vaccination
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
- Derived from this study: PubMed 25483635Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rabies, 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 3 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: stopped early, as of the sponsor's last update on 30 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.
Are results available for this study?
The study was stopped early. 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?
Rabies virus neutralizing antibody(RVNA) responses 13months, 3 years and 5 years after completion of initial vaccination series as evaluated by percentage of subjects with RVNA greater than or equal to 0.5 IU/mL (time frame: 13 months, 3 years and 5 years after initial vaccination). 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 NCT01067079, 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 30 Dec 2011.