Agency/committee | Composition of the experimental vaccine | Composition of the comparator |
Danish Medicines Agency Danish National Committee on Health Research Ethics | 225 mcg aluminium as potassium aluminium sulfate 9.56 mg sodium chloride 0.78 mg L-histidine 50 mcg polysorbate 80 35 mcg borax | 225 mcg aluminium as potassium aluminium sulfate 9.56 mg sodium chloride 0.78 mg L-histidine 50 mcg polysorbate 80 35 mcg borax |
Protocol | 225 mcg aluminium as amorphous aluminium hydroxyphosphate sulfate (Merck aluminium adjuvant) | Merck standard aluminium diluent (225 µg alum) in normal saline, unique selling proposition (NaCl 0.9%) or Merck aluminium adjuvant placebo |
Recruitment brochure | No information | Saline |
Informed consent form | No information | Saline |