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A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a...

Update Il y a 4 ans
Reference: EUCTR2009-015321-37

A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

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Extract

To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months after the administration of the toddler dose in study 6096A1-008-EU, as measured by serotype-specific (immunoglobulin G) IgG concentrations. To evaluate the immune response to 13 pneumococcal vaccine serotypes 1 month after a dose of 13vPnC administered not earlier than 24 months after the toddler dose in study 6096A1-008-EU, as measured by serotype specific IgG concentrations.

Inclusion criteria

  • Pneumococcal infection

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