Phase 1/2a, randomised, double-blinded, placebo-controlled, dose- escalation study
Phase 1/2a, randomised, double-blinded, placebo-controlled, dose- escalation study to evaluate the safety, tolerability, Immunogenicity and vaccine-like viral shedding of MEDI-534, a live, attenuated intranasal vaccine against respiratory syncytical virus (RSV) and parainfluenza virus type 3 (PIV 3), in healthy 6 - <24 month-old children in and 2 month old infants
RSV and PIV3 are important causes of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia in infants and young children.
The purpose of this study is to describe the safety, immune
response (ability of the body to fight infection), and virus
shedding (virus that can be found in the nose after vaccination) of
an experimental live PIV3 and RSV nasal vaccine called MEDI 534 in
comparison to a placebo (an inactive sugar and salt solution that
does not contain the vaccine, MEDI-534). MEDI -534 or placebo
is given as nose drops in this study.
Recruitment for this study was completed in 2011, all subjects have received there last dose of Investigational Product. The study is in phone call follow up of which the last calls will take place in October 2012. The Vaccines Trials Group recruited 4 participants to this study. All visits and phone call follow ups were completed in January 2012.
Funders of the project - MedImmune
Dr Peter Richmond, Dr Tanya Stoney