RabiesPhase 3NCT00825305
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
A Phase 3 study testing Abbreviated Zagreb 2-1-1 schedule and Standard Essen 1-1-1-1-1 schedule in people with Rabies, run by Novartis Vaccines at 1 site in China.
Trial summary
This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Abbreviated Zagreb 2-1-1 schedule and Standard Essen 1-1-1-1-1 schedule
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects 18-50 years of age who:
- are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
- volunteer for the simulated post-exposure vaccination courses and blood draws;
- have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
- are available for all the visits scheduled in the study.
Who cannot join
- Subjects with the below criteria were excluded:
- pregnancy or unwillingness to practice acceptable contraception during participation in the study;
- a history of rabies immunization;
- a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
- fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
- treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;
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- administration of any vaccine within the past 14 days before enrolment;
- known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
- history of allergy to egg protein;
- known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;
- treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;
- mental condition rendering the subject unable to understand the nature, scope and consequences of the study;
- participation in any other investigational trial within the past 3 months before enrolment;
- planned surgery during the study period;
- intention to leave the area of the study site before the end of study period;
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China
This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China
- Conditions
- Rabies
- Being tested
- Abbreviated Zagreb 2-1-1 schedule, Standard Essen 1-1-1-1-1 schedule
- Keywords
- vaccine, prevention, rabies, Rabies disease
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated Zagreb 2-1-1 scheduleBiological
Also called PCEC Rabies vaccine for human use
Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.
Standard Essen 1-1-1-1-1 scheduleBiological
Also called PCEC Rabies vaccine for human use
Subjects received the standard Essen regimen.
| Study group | Role | What they receive |
|---|---|---|
| Zagreb (2-1-1) | Experimental | Rabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively Receives: Biological: Abbreviated Zagreb 2-1-1 schedule |
| Essen (1-1-1-1-1) | Active comparator | Rabies PCEC vaccine was applied according Essen schedule, i.e. 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. Receives: Biological: Standard Essen 1-1-1-1-1 schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies Virus Neutralizing Antibody Concentrations on Day 14.
Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Measured: 14 days
Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination
Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.
Measured: 7 days after each vaccination
Secondary outcomes (2)
Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.
Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Measured: 7 days and 42 days
Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.
Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.
Measured: 7 days, 14 days and 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825305
- Sponsor's protocol ID
- M49P8
- Status last verified
- Dec 2011
- First submitted
- 19 Jan 2009
- Last updated
- 13 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
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 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China
- ClinicalTrials.gov ID
- NCT00825305
- Acronym / sponsor ID
- M49P8
- Conditions
- Rabies
- Keywords
- vaccine, prevention, rabies, Rabies disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 19 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zagreb (2-1-1) | Experimental | Biological: Abbreviated Zagreb 2-1-1 scheduleRabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively |
| Essen (1-1-1-1-1) | Active comparator | Biological: Standard Essen 1-1-1-1-1 scheduleRabies PCEC vaccine was applied according Essen schedule, i.e. 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects 18-50 years of age who:
- are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
- volunteer for the simulated post-exposure vaccination courses and blood draws;
- have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
- are available for all the visits scheduled in the study.
Key exclusion criteria (16 listed)
- Subjects with the below criteria were excluded:
- pregnancy or unwillingness to practice acceptable contraception during participation in the study;
- a history of rabies immunization;
- a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
- fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
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 |
|---|---|---|
| Abbreviated Zagreb 2-1-1 scheduleAlso: PCEC Rabies vaccine for human useSubjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase. | Biological | Zagreb (2-1-1) |
| Standard Essen 1-1-1-1-1 scheduleAlso: PCEC Rabies vaccine for human useSubjects received the standard Essen regimen. | Biological | Essen (1-1-1-1-1) |
Primary outcome
Rabies Virus Neutralizing Antibody Concentrations on Day 14.
Time frame: 14 days
Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination
Time frame: 7 days after each vaccination
Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.
2 secondary outcomes
Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.
Time frame: 7 days and 42 days
Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.
Time frame: 7 days, 14 days and 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 3 study testing Abbreviated Zagreb 2-1-1 schedule and Standard Essen 1-1-1-1-1 schedule in people with 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 5 inclusion and 16 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 13 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?
Yes. Results are posted in the registry (first posted 19 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 on Day 14. (time frame: 14 days). The study lists 2 primary outcomes in all. 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 NCT00825305, 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 13 Dec 2011.