Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT00948272|
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : May 28, 2014
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.
- 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.
- 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 or disease||Intervention/treatment||Phase|
|Rabies||Biological: Purified Vero Rabies Vaccine - Serum Free Biological: Purified inactivated rabies vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||384 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||August 2011|
|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
- To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. [ Time Frame: 42 days post-primary series vaccination ]
- To provide information concerning the safety after Purified Vero Rabies Vaccine. [ Time Frame: 0 to 7 days post-vaccination and entire study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948272
|Gières, France, 38610|
|Montpellier Cedex 5, France, 34094|
|Pierre Bénite, France, 69130|
|Poitiers, France, 86000|
|Rennes, France, 35000|
|Rueil Malmaison, France, 92502|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|