Invasive meningococcal disease (IMD)
Conditions
Brief summary
hSBA titers against each MenB indicator strain at Visit 2 (Day 31).
Detailed description
hSBA titers against each MenB indicator strain at Visit 2 (Day 31)., hSBA titers against each MenB indicator strain at Visit 1 (Day 1)., • Occurrence of solicited administration site and systemic events within 7 days following the first vaccination. • Occurrence of any unsolicited AEs within 31 days (including the day of injection) following the first vaccination. • Occurrence of AESI (arthritis), SAEs, AEs leading to withdrawal throughout the study period (Day 1 to Day 31).
Interventions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hSBA titers against each MenB indicator strain at Visit 2 (Day 31). | — |
Secondary
| Measure | Time frame |
|---|---|
| hSBA titers against each MenB indicator strain at Visit 2 (Day 31)., hSBA titers against each MenB indicator strain at Visit 1 (Day 1)., • Occurrence of solicited administration site and systemic events within 7 days following the first vaccination. • Occurrence of any unsolicited AEs within 31 days (including the day of injection) following the first vaccination. • Occurrence of AESI (arthritis), SAEs, AEs leading to withdrawal throughout the study period (Day 1 to Day 31). | — |
Countries
Finland, Italy, Spain
Outcome results
None listed