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A phase I/II, randomized, observer blinded study to evaluate and compare the safety, reactogenicity and immunogenicity of various formulations of the GlaxoSmithKline Biologicals’ adjuvanted 11-valent ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005682-11

A phase I/II, randomized, observer blinded study to evaluate and compare the safety, reactogenicity and immunogenicity of various formulations of the GlaxoSmithKline Biologicals’ adjuvanted 11-valent pneumococcal conjugate vaccine versus the licensed single-dose 23-valent pneumococcal polysaccharide vaccine and GlaxoSmithKline Biologicals’ aluminium-based 10-valent pneumococcal conjugate vaccine, in healthy elderly subjects

Femme et Homme

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Extrait

• To assess in healthy elderly subjects the safety and reactogenicity of the 11PCV adjuvanted either with AS01B or AS01E or AS02V, and of the 10-valent pneumococcal conjugate vaccine adjuvanted with AlPO4 (10PCV/AlPO4), given as a 2-dose vaccination 3 months apart, and of the licensed 23-valent pneumococcal polysaccharide vaccine (23PPV) given as a 1-dose vaccination. • To compare the antibody response of the 11PCV, adjuvanted either with AS01B, AS01E or AS02V, after 1 and 2 injections with the antibody response of the 23PPV.

Critère d'inclusion

  • Two doses vaccination in elderly subjects aged between 65 and 85 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine (Pneumo 23)

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