MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants

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Study title: 
MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants
EU record number: 
B/BE/08/BVW1
EudraCT number: 
2008-002651-24
Pharmaceutical study code: 
MI-CP178
Company / Sponsor: 
MedImmune LLC
Phase: 
I/II a
Treated organism: 
Humans
Indication category: 
Infectious disease
Disease: 
lower respiratory tract illness
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
Method of transfer of nucleic acid of interest: 
Attenuated Bovine Parainfluenza Virus type 3 strain bPIV3/15626/84
Administered biological material: 
Recombinant Attenuated Bovine Parainfluenza Virus
Route of administration: 
Intranasal
Locations in Belgium: 
Flanders, Wallonia and Brussels as a consequence of clinical trials conducted with children potentially recruited at: - UZ Brussels - St-Vincentiusziekenhuis, Antwerp.
Nr of subjects: 
20 to 30 subjects in Belgium; 720 worldwide
Foreseen duration: 
3 years
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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