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A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-015174-35

A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks

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Extrait

To evaluate the safety and reactogenicity of the H1N1 candidate vaccine in terms of solicited local and general symptoms, unsolicited adverse events (AEs) and serious adverse events (SAEs) two weeks post Dose 1.

Critère d'inclusion

  • Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks

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