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

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

Pharmaceutical study code

MI-CP178

Information for the public

Information related to the decision procedure

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