RabiesPhase 4NCT00260351
Immunogenicity and Safety of Verorab™ in Indian Population
A Phase 4 study testing Purified Verocell Rabies Vaccine in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 3 sites in India.
Trial summary
To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or, To demonstrate that… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Rabies
- What is being tested?
- Purified Verocell Rabies Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 3 sitesIndia
- Study dates
- Dec 2004to Oct 2008
- Phase
- Phase 4
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with WHO category III rabies exposure
- Subject aged at least 2 years old (day of second birthday)
Who cannot join
- Subject unable to comply with the follow-up schedule of the protocol
- Delayed post-exposure treatment (>72 hours between incident and treatment
- Subject bitten by an observable animal at the inclusion visit
- Subject with immune-compromised or underlying diseases which may lead to inferior immune response
- Subject with known pregnancy at the time of inclusion
- Subject enrolled or scheduled to be enrolled in another clinical study.
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- Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius
- Subject in whom blood sampling will be difficult.
- Subject receiving chloroquine or other anti-malarial treatment
- Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs
- Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.)
- Previous rabies immunization
- Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin
- Subject with clinical signs of rabies
- Subject with known allergy to vaccine components (e.g. neomycin)
- Subject who received blood and/or plasma transfusion within the past 3 months
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine (PVRV, Verorab™) Administered for Rabies Post-exposure Treatment. Comparison of Essen-IM, Zagreb-IM, and Thai Red Cross (TRC)-ID Regimens in the Indian Population.
- To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or,
- To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.
Secondary objectives:
- To describe the immunogenicity profile of each regimen
- To assess the safety of the vaccine in each group.
- Conditions
- Rabies
- Being tested
- Purified Verocell Rabies Vaccine
- Keywords
- rabies;, rabies post-exposure;, category III
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified Verocell Rabies VaccineBiological
Also called PVRV, VERORAB
0.1 mL, ID (TRC regimen)
Purified Verocell Rabies VaccineBiological
Also called PVRV, VERORAB
0.5 mL, IM (ZAGREB regimen)
Purified Verocell Rabies VaccineBiological
Also called PVRV, VERORAB
0.5 mL, IM (ESSEN regimen)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants on Thai Red Cross, TRC-ID regimen Receives: Biological: Purified Verocell Rabies Vaccine |
| Group 2 | Experimental | Participants on Zagreb-IM regimen Receives: Biological: Purified Verocell Rabies Vaccine |
| Group 3 | Experimental | Participants on Essen-IM regimen. Receives: Biological: Purified Verocell Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
Measured: 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2008
- Study completionOct 2008
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.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260351
- Sponsor's protocol ID
- RAB28
- Status last verified
- Jan 2014
- First submitted
- 29 Nov 2005
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine (PVRV, Verorab™) Administered for Rabies Post-exposure Treatment. Comparison of Essen-IM, Zagreb-IM, and Thai Red Cross (TRC)-ID Regimens in the Indian Population.
- ClinicalTrials.gov ID
- NCT00260351
- Acronym / sponsor ID
- RAB28
- Conditions
- Rabies
- Keywords
- rabies;, rabies post-exposure;, category III
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Dec 2005 (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.
- To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects with a WHO category III rabies exposure,or,
- To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen (2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.
Secondary objectives:
- To describe the immunogenicity profile of each regimen
- To assess the safety of the vaccine in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Purified Verocell Rabies VaccineParticipants on Thai Red Cross, TRC-ID regimen |
| Group 2 | Experimental | Biological: Purified Verocell Rabies VaccineParticipants on Zagreb-IM regimen |
| Group 3 | Experimental | Biological: Purified Verocell Rabies VaccineParticipants on Essen-IM regimen. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with WHO category III rabies exposure
- Subject aged at least 2 years old (day of second birthday)
Key exclusion criteria (16 listed)
- Subject unable to comply with the follow-up schedule of the protocol
- Delayed post-exposure treatment (>72 hours between incident and treatment
- Subject bitten by an observable animal at the inclusion visit
- Subject with immune-compromised or underlying diseases which may lead to inferior immune response
- Subject with known pregnancy at the time of inclusion
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 |
|---|---|---|
| Purified Verocell Rabies VaccineAlso: PVRV, VERORAB0.1 mL, ID (TRC regimen) | Biological | Group 1 |
| Purified Verocell Rabies VaccineAlso: PVRV, VERORAB0.5 mL, IM (ZAGREB regimen) | Biological | Group 2 |
| Purified Verocell Rabies VaccineAlso: PVRV, VERORAB0.5 mL, IM (ESSEN regimen) | Biological | Group 3 |
Primary outcome
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
Time frame: 6 months post-vaccination
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 Jan 2014.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Purified Verocell Rabies Vaccine in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 3 sites in India.
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 2 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine (time frame: 6 months post-vaccination). 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 Jan 2014.