Safety and immunogenicity of GSK Biologicals’ (pre-) pandemic influenza vaccine in children aged 6 to 35 months

Update Il y a 4 ans
Reference: EUCTR2011-004734-33

Woman and Man

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Extract

To assess whether a heterologous booster dose of 1.9 µg A/turkey/Turkey/1/2005 (H5N1) HA with AS03B given 6 months following a 2-dose primary vaccination series with 1.9 µg A/Indonesia/05/2005 (H5N1) HA with AS03B elicits an antibody response that meets the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) guidance targets for pre-pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR) and mean geometric increase (MGI) based on HI responses to A/turkey/Turkey/1/2005 (H5N1) ten days following booster vaccination.


Inclusion criteria

  • Immunisation of healthy children aged 6 to 35 months against H5N1 influenza

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