Godkendelsen var baseret på resultaterne af kliniske undersøgelser af den immunogene og reaktogene aktivitet af Hexavac, når stoffet indgives ifølge bestemte primære og booster vaccinationsprogrammer.
The approval was based on results from clinical trials, which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules.