Purified Vero Rabies Vaccine - Serum Free
Biological0.5 mL, Intramuscular
Other names: VRVg
NCT Number: NCT00948272
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Gières, France
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 mL, Intramuscular
Other names: VRVg
0.5 mL, Intramuscular
Other names: Verorab
Time frame: 42 days post-primary series vaccination
Time frame: 0 to 7 days post-vaccination and entire study duration
Sanofi Pasteur, a Sanofi Company
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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