| 
            B/BE/21/BVW9           | 
                  
            Dossier withdrawn by the notifier           | 
                  
                  
            Humans           | 
                  
            V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)           | 
              
          
                  | 
            Only notified under the "contained use" procedure. Dossier submitted on 07/04/2014.           | 
                  
            A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects            | 
                  
                  
            Humans           | 
                  
            gene expressing certolizumab           | 
              
          
                  | 
            B/BE/12/BVW2           | 
                  
            Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure           | 
                  
                  
            Humans           | 
                  
            Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle           | 
              
          
                  | 
            Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012.           | 
                  
            A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects            | 
                  
                  
            Humans           | 
                  
            Human Trefoil Factor 1            | 
              
          
                  | 
            B/BE/07/BVW3           | 
                  
            A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients           | 
                  
                  
            Humans           | 
                  
            Hepatitis B virus polyepitope gene           |