Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination. Booster Extension: Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.
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Rate of SAEs to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of related SAEs to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of any solicited or unsolicited Grade 3 or Grade 4 events up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of any solicited or related unsolicited Grade 3 or Grade 4 events up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of solicited local AEs within 7 days after each and after any vaccination up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of solicited systemic AEs within 7 days after each and after any vaccination up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
Timeframe: up to Day 84 (Month 3) after first vaccination
Rate of related unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
Timeframe: up to Day 84 (Month 3) after first vaccination