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A phase III, randomised, observer-blind, multicentre study to evaluate the immunogenicity and safety of a 2-dose vaccination with the new process manufactured adjuvanted pandemic H1N1 influenza candid...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-015960-32

A phase III, randomised, observer-blind, multicentre study to evaluate the immunogenicity and safety of a 2-dose vaccination with the new process manufactured adjuvanted pandemic H1N1 influenza candidate vaccine in children aged 3 to 9 years old

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Extrait

To evaluate whether the humoral immune response of the 3.75 µg dosage with AS03A H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination. To evaluate whether the humoral immune response of the 1.9 µg dosage with AS03B H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination.

Critère d'inclusion

  • Immunisation of healthy children aged 3 years to 9 years against novel H1N1 influenza of pandemic potential

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