Harabacz 1992.

Methods	Design: randomized controlled trial with 7 centres Generation of allocation sequence: not described Allocation concealment: not described Blinding: double blind Inclusion of all randomized participants in the analysis: 379/379 (100%) for safety; 356/379 (94%) for efficacy Length of follow up: for immunogenicity (328 days for conventional schedule; 321 for abbreviated schedule); for safety (28 days after each immunization respect to adverse drug events and 5 days for axillary body temperature)
Participants	Number: 379 healthy adults aged 18 to 69 years (240 male and 139 female) Inclusion criteria: not described Exclusion criteria: not described
Interventions	Vaccine: Encepur Dose‐finding study (3 different doses and 2 immunization schedules): 1. 1.0 µg/0.5 mL 2. 1.5 µg/0.5 mL 3. 2.0 µg/0.5 mL Schedules (3 doses): 1. Conventional (days 0, 28, and 300) 2. Abbreviated (days 0, 7, and 21) Immunization was intramuscular in the deltoid
Outcomes	1. Seroconversion at days 28, 42, 56, 300, 314, and 328 (conventional) and at days 21, 35, and 321 (abbreviated); antibody titres were assayed by enzyme‐linked immunosorbent assay (ELISA), haemagglutination inhibition test, and neutralization test; lower limit for seroconversion defined as 8 in haemagglutination inhibition test, 2 in neutralization test and 160 in ELISA; geometric mean of tick‐borne encephalitis (TBE) antibody titres on the same days 2. Adverse events assessed up to 28 days following each vaccination: asthenia, malaise, fever (> 37.5 °C; within 5 days after each dose), injection site hypersensitivity and/or pain, headache
Notes	Location: TBE‐endemic areas near 7 study centres (3 in Germany, 1 in Czechoslovakia, 2 in Yugoslavia, and 1 in Switzerland)