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A phase II, double-blind study to evaluate the safety, reactogenicity and immunogenicity of two different formulations of GSK Biologicals’ pneumococcal protein candidate vaccine, when given as a boos...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-011022-33

A phase II, double-blind study to evaluate the safety, reactogenicity and immunogenicity of two different formulations of GSK Biologicals’ pneumococcal protein candidate vaccine, when given as a booster dose in healthy young adults previously vaccinated in the primary vaccination study SPNG-001 (111651)

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Extrait

•To assess the safety and reactogenicity of a booster dose of two formulations of GSK Biologicals’ candidate pneumococcal proteins vaccine when administered intramuscularly in healthy adults, in terms of vaccine-related and grade 3 solicited, unsolicited AEs and haematological or biochemical abnormalities and vaccine-related SAEs.

Critère d'inclusion

  • Booster vaccination with a pneumococcal protein candidate vaccine in healthy young adults aged between 18 and 41 years old, previously primed with 2 doses of pneumococcal protein vaccine in study SPNG-001

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