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The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults...

Update Il y a 5 ans
Reference: EUCTR2014-004248-36

The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in Children 6 to <72 months of age, Mexican population, in comparison to Fluzone, a non adjuvanted Trivalent Influenza Vaccine (TIV)

Woman and Man

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Extract

1. To assess the safety of aTIV and TIV vaccines administered to healthy subjects 6 to <72 months of age, from day 1 to day 50 (naïve subjects) and from day 1 to day 22 (non-naïve subjects). 2. To demonstrate non-inferiority of aTIV to TIV as measured by geometric mean titers (GMTs) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.

Inclusion criteria

  • Influenza

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