A phase II, open, non-randomized study designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adul...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000115-28

A phase II, open, non-randomized study designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine H5N1 A/Vietnam/1194/2004 containing 3.8, 7.5, 15 or 30 µg HA, adjuvanted or not with AS03

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Extrait

To assess if the humoral immune response induced 21 days after one booster administration of the pandemic influenza vaccine fulfils the criteria established by the European Committee for Medicinal Products for Human Use (CHMP) in subjects primed approximately 14 months earlier with two administrations (21 days apart) of the candidate vaccine formulated from an heterologous strain and adjuvanted with AS03.


Critère d'inclusion

  • Since 1997, avian H5N1 influenza has caused several human infections and high mortality rate in Southeast Asia. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate ‘pandemic-like’ vaccines must be developed and tested in clinical trials to determine the best vaccination schedule

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