RabiesPhase 2NCT00948272
Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults
A Phase 2 study testing Purified Vero Rabies Vaccine - Serum Free and Purified inactivated rabies vaccine in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 6 sites in France.
Trial summary
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration. Primary Objective: To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Purified Vero Rabies Vaccine - Serum Free and Purified inactivated rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 6 sitesFrance
- Study dates
- Jul 2009to Aug 2011
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 60 years on the day of inclusion
- Provision of a signed Informed Consent Form
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)
- Entitlement to national social security
Who cannot join
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
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- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
- Previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen)
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- Subject at high risk for rabies exposure during the trial period
- Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
- Study site employee who is involved in the protocol and may have direct access to trial related data.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Study site
Gières, 38610
Study site
Montpellier, 34094
Study site
Pierre-Bénite, 69130
Study site
Poitiers, 86000
Study site
Rennes, 35000
Study site
Rueil-Malmaison, 92502
About this study
Official title: Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.
Primary Objective:
Read more
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
- To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
Read the detailed description
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
- Conditions
- Rabies
- Being tested
- Purified Vero Rabies Vaccine - Serum Free, Purified inactivated rabies vaccine
- Keywords
- Rabies, Rabies virus, Purified Vero Rabies Vaccine, Serum Free
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified Vero Rabies Vaccine - Serum FreeBiological
Also called VRVg
0.5 mL, Intramuscular
Purified inactivated rabies vaccineBiological
Also called Verorab
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| VRVg Group | Experimental | Not described Receives: Biological: Purified Vero Rabies Vaccine - Serum Free |
| Verorab Group | Active comparator | Not described Receives: Biological: Purified inactivated rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
Measured: 42 days post-primary series vaccination
Secondary outcomes (1)
To provide information concerning the safety after Purified Vero Rabies Vaccine.
Measured: 0 to 7 days post-vaccination and entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionAug 2011
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 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
- NCT00948272
- Sponsor's protocol ID
- VRV01
- Other IDs
- UTN: U1111-1111-4382
- Status last verified
- May 2014
- First submitted
- 28 Jul 2009
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial. Vaccine. 2013 Apr 26;31(18):2295-301. doi: 10.1016/j.vaccine.2013.02.058. Epub 2013 Mar 16.
PubMed 23510665
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
- ClinicalTrials.gov ID
- NCT00948272
- Acronym / sponsor ID
- VRV01
- Conditions
- Rabies
- Keywords
- Rabies, Rabies virus, Purified Vero Rabies Vaccine, Serum Free
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Jul 2009 (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.
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.
Primary Objective:
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
- To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
Detailed description
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRVg Group | Experimental | Biological: Purified Vero Rabies Vaccine - Serum Free |
| Verorab Group | Active comparator | Biological: Purified inactivated rabies vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 60 years on the day of inclusion
- Provision of a signed Informed Consent Form
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)
- Entitlement to national social security
Key exclusion criteria (18 listed)
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
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 Vero Rabies Vaccine - Serum FreeAlso: VRVg0.5 mL, Intramuscular | Biological | VRVg Group |
| Purified inactivated rabies vaccineAlso: Verorab0.5 mL, Intramuscular | Biological | Verorab Group |
Primary outcome
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
Time frame: 42 days post-primary series vaccination
1 secondary outcome
To provide information concerning the safety after Purified Vero Rabies Vaccine.
Time frame: 0 to 7 days post-vaccination and entire study duration
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 28 May 2014.
- Results publication: PubMed 23510665Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial. Vaccine. 2013 Apr 26;31(18):2295-301. doi: 10.1016/j.vaccine.2013.02.058. Epub 2013 Mar 16.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Purified Vero Rabies Vaccine - Serum Free and Purified inactivated rabies vaccine in people with Rabies, run by Sanofi Pasteur, a Sanofi Company at 6 sites in France.
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 18 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. (time frame: 42 days post-primary series 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 NCT00948272, 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 28 May 2014.