All concomitant medications, with the exception of vitamins and/or dietary supplements, administered at ANY time during the 30 days (Days 0 -29) after each vaccination are to be recorded in the eCRF. This also applies to concomitant medication administered prophylactically in anticipation of reaction to the vaccination and any medication intended to treat an AE.
A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [oral/tympanic on oral