RabiesPhase 3NCT01339312
Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine
A Phase 3 study testing Purified inactivated rabies vaccine, serum free and Purified Vero Rabies Vaccine in people with Rabies and Rabies Virus, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.
Trial summary
This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rabies, Rabies Virus
- What is being tested?
- Purified inactivated rabies vaccine, serum free and Purified Vero Rabies Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Sep 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults (≥ 18 years)
- Aged ≥ 18 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
- Subjects aged 10-17 years:
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- Aged 10 to 17 years on the day of inclusion
- Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by subjects aged 12 years and over. In addition, provision of assent form signed by subjects aged 10 to 11 years
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine during the course of the trial
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
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- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, or reported by the parent/guardian
- At high risk for rabies infection during the trial: (such as veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies is enzootic, previous bite by a rabid animal with no post-exposure treatment administered)
- Known systemic hypersensitivity to any of the vaccine components , or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self-reported thrombocytopenia, contraindicating intramuscular vaccination, or reported by the parent/guardian
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Post-exposure Use in Healthy Subjects in China
This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations.
Primary Objective:
Read more
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall
- To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.
Read the detailed description
All participants will receive five vaccinations (on Days 0, 3, 7, 14, and 28) and will be assessed for immunogenic response on Days 0, 14, and 42. They will also be monitored for safety from the day of the first vaccination and for up to 6 months after the final vaccination.
- Conditions
- Rabies, Rabies Virus
- Being tested
- Purified inactivated rabies vaccine, serum free, Purified Vero 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 inactivated rabies vaccine, serum freeBiological
Also called Purified Vero Rabies Vaccine Serum Free
0.5 mL, Intramuscular
Purified inactivated rabies vaccine, serum freeBiological
Also called Purified Vero Rabies Vaccine Serum Free
0.5 mL, Intramuscular
Purified Vero Rabies VaccineBiological
Also called Verorab Vaccine
0.5 mL, Intramuscular
Purified Vero Rabies VaccineBiological
Also called Verorab Vaccine
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| VRVg Vaccine Group 1 | Experimental | Participants aged 18 years or older will receive Purified Vero Rabies Vaccine Serum Free (VRVg) Receives: Biological: Purified inactivated rabies vaccine, serum free |
| VRVg Vaccine Group 2 | Experimental | Participants aged 10 to 17 years will receive Purified Vero Rabies Vaccine Serum Free (VRVg) Receives: Biological: Purified inactivated rabies vaccine, serum free |
| Verorab Vaccine Group 1 | Active comparator | Participants aged 18 years or older will receive Verorab Vaccine Receives: Biological: Purified Vero Rabies Vaccine |
| Verorab Vaccine Group 2 | Active comparator | Participants aged 10 to 17 years will receive Verorab Vaccine Receives: Biological: Purified Vero Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination
Rabies virus neutralizing antibody (RVNA) titer as determined by rapid fluorescent focus inhibition test (RFFIT)
Measured: Day 14
Secondary outcomes (1)
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination.
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.
Measured: Day 1 up to 6 months post last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionSep 2012
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 816 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 SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339312
- Sponsor's protocol ID
- VRV08
- Other IDs
- U1111-1117-7193
- Status last verified
- May 2014
- First submitted
- 19 Apr 2011
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Li R, Huang L, Li J, Mo Z, He B, Wang Y, Wu X, Minutello M, Guinet-Morlot F, Pichon S. A next-generation, serum-free, highly purified Vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab(R) when administered according to a post-exposure regimen in healthy children and adults in China. Vaccine. 2013 Dec 5;31(50):5940-7. doi: 10.1016/j.vaccine.2013.10.043. Epub 2013 Oct 19.
PubMed 24148575
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 and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Post-exposure Use in Healthy Subjects in China
- ClinicalTrials.gov ID
- NCT01339312
- Acronym / sponsor ID
- VRV08
- Conditions
- Rabies, Rabies Virus
- Keywords
- Rabies, Rabies virus, Purified Vero Rabies Vaccine - Serum Free
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Apr 2011 (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 is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations.
Primary Objective:
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall
- To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.
Detailed description
All participants will receive five vaccinations (on Days 0, 3, 7, 14, and 28) and will be assessed for immunogenic response on Days 0, 14, and 42. They will also be monitored for safety from the day of the first vaccination and for up to 6 months after the final vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VRVg Vaccine Group 1 | Experimental | Biological: Purified inactivated rabies vaccine, serum freeParticipants aged 18 years or older will receive Purified Vero Rabies Vaccine Serum Free (VRVg) |
| VRVg Vaccine Group 2 | Experimental | Biological: Purified inactivated rabies vaccine, serum freeParticipants aged 10 to 17 years will receive Purified Vero Rabies Vaccine Serum Free (VRVg) |
| Verorab Vaccine Group 1 | Active comparator | Biological: Purified Vero Rabies VaccineParticipants aged 18 years or older will receive Verorab Vaccine |
| Verorab Vaccine Group 2 | Active comparator | Biological: Purified Vero Rabies VaccineParticipants aged 10 to 17 years will receive Verorab Vaccine |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adults (≥ 18 years)
- Aged ≥ 18 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
Key exclusion criteria (18 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine during the course of the trial
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
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 inactivated rabies vaccine, serum freeAlso: Purified Vero Rabies Vaccine Serum Free0.5 mL, Intramuscular | Biological | VRVg Vaccine Group 1 |
| Purified inactivated rabies vaccine, serum freeAlso: Purified Vero Rabies Vaccine Serum Free0.5 mL, Intramuscular | Biological | VRVg Vaccine Group 2 |
| Purified Vero Rabies VaccineAlso: Verorab Vaccine0.5 mL, Intramuscular | Biological | Verorab Vaccine Group 1 |
| Purified Vero Rabies VaccineAlso: Verorab Vaccine0.5 mL, Intramuscular | Biological | Verorab Vaccine Group 2 |
Primary outcome
Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination
Time frame: Day 14
Rabies virus neutralizing antibody (RVNA) titer as determined by rapid fluorescent focus inhibition test (RFFIT)
1 secondary outcome
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination.
Time frame: Day 1 up to 6 months post last 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 28 May 2014.
- Results publication: PubMed 24148575Li R, Huang L, Li J, Mo Z, He B, Wang Y, Wu X, Minutello M, Guinet-Morlot F, Pichon S. A next-generation, serum-free, highly purified Vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab(R) when administered according to a post-exposure regimen in healthy children and adults in China. Vaccine. 2013 Dec 5;31(50):5940-7. doi: 10.1016/j.vaccine.2013.10.043. Epub 2013 Oct 19.
- 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 SA
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 Purified inactivated rabies vaccine, serum free and Purified Vero Rabies Vaccine in people with Rabies and Rabies Virus, run by Sanofi Pasteur, a Sanofi Company 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 10 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 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?
Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination (time frame: Day 14). 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 NCT01339312, 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.