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A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscularly ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-006651-39

A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscularly according to a 0, 1, 6-month schedule in females aged 18-25 years

Femme Homme

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Extrait

To evaluate whether there is an increased incidence of neuroinflammatory AIDs or other autoimmune diseases, with onset during the theoretical risk period of 12 months (the period beginning with administration of the first dose and ending 6 months after the last dose of vaccine) in the group vaccinated with Cervarix® compared to the group vaccinated with Havrix®.

Critère d'inclusion

  • No medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to be related to the vaccine

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