Eder 2003ii.

Methods	Design: randomized controlled trial Generation of allocation sequence: not described Allocation concealment: not described Blinding: double blind Inclusion of all randomized participants in the analysis: no participants lost to follow up in immunogenicity analysis 21 participants lost from safety (92% included in analysis) Length of follow up: for immunogenicity, serological texts were performed before first dose and 4 weeks after second and third dose (about 12 months after the first dose administration); for adverse effects, within 7 days after each of the 3 doses
Participants	Number: 261 children aged 4 to 12 years Inclusion criteria: not described Exclusion criteria: for immunogenicity positive tick‐borne encephalitis (TBE) antibody at screening; tick bite during the study; retraction of informed consent or failure to appear at scheduled examination (36 participants)
Interventions	Vaccine: TicoVac Immunogenicity trial, comparison of 2 doses (seeEder 2003i): 1. 1.65 µg of TBE virus antigen/0.25 mL vs 3.29 µg of TBE virus antigen/0.5 mL 2. 1.65 µg of TBE virus antigen/0.25 mL vs 3.29 µg of TBE virus antigen/0.5 mL 3. 1.65 µg of TBE virus antigen/0.25 mL vs 3.29 µg of TBE virus antigen/0.5 mL Schedule: dose 1, day 0; dose 2, 14 to 32 days after dose 1; dose 3, 9 to 10 months after dose 2
Outcomes	1. Antibody responses determined by enzyme‐linked immunosorbent assay (ELISA) before dose 1 and after doses 2 and 3 1.1. Seroconversion, defined as a positive ELISA result of at least 126 Vienna International Units (VIEU)/mL (Kiessig 93) or 4‐fold titre increase 1.2. Geometrical mean concentration (VIEU/mL by ELISA) 2. Adverse events (follow‐up for 7 days after each vaccination, diary card filled by parents and reviewed by study physicians): fever (mild: < 38.5 °C; moderate: 38.5 °C to 40 °C; severe: > 40 °C)
Notes	Location: Germany