Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00948272
First received: July 28, 2009
Last updated: October 5, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rabies |
Biological: Purified Vero Rabies Vaccine - Serum Free Biological: Purified inactivated rabies vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Rabies
Drug Information available for:
Rabies Vaccine
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. [ Time Frame: 42 days post-primary series vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To provide information concerning the safety after Purified Vero Rabies Vaccine. [ Time Frame: 0 to 7 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 384 |
| Study Start Date: | July 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: VRVg Group |
Biological: Purified Vero Rabies Vaccine - Serum Free
0.5 mL, Intramuscular
Other Name: VRVg
|
| Active Comparator: Verorab Group |
Biological: Purified inactivated rabies vaccine
0.5 mL, Intramuscular
Other Name: Verorab
|
Detailed Description:
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- 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
Exclusion Criteria :
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948272
Locations
| France | |
| Gières, France, 38610 | |
| Montpellier Cedex 5, France, 34094 | |
| Pierre Bénite, France, 69130 | |
| Poitiers, France, 86000 | |
| Rennes, France, 35000 | |
| Rueil Malmaison, France, 92502 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00948272 History of Changes |
| Other Study ID Numbers: | VRV01, UTN: U1111-1111-4382 |
| Study First Received: | July 28, 2009 |
| Last Updated: | October 5, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Sanofi:
|
Rabies Rabies virus Purified Vero Rabies Vaccine Serum Free |
Additional relevant MeSH terms:
|
Rabies Rhabdoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013