The main purpose of this study is to evaluate the immune response and safety of a booster dose of the meningococcal group B vaccine, rMenB+OMV NZ (also known as Bexsero), in adolescents and young adults aged 10 to 20 years. This study focuses on individuals who were first vaccinated with rMenB+OMV NZ as infants. The primary hypothesis is that a booster dose of the vaccine will elicit a stronger immune response in these primed individuals compared to those who have never received any group B meningococcal vaccine, referred to as 'nave' participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
312
1 dose in the Primed group or 2 doses in the Naive group.
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kokkola, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Seinäjoki, Finland
GSK Investigational Site
Tampere, Finland
GSK Investigational Site
Turku, Finland
GSK Investigational Site
Florence, Italy
GSK Investigational Site
Genova, Italy
...and 7 more locations
hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain
Time frame: At Day 31
Number of participants with hSBA titers greater than or equal (>=) to pre-defined limit of detection against each MenB indicator strain
Time frame: At Day 31
Number of participants with hSBA titers >= lower limit of quantification (LLOQ) against each MenB indicator strain
Time frame: At Day 31
Number of participants with four-fold increase in hSBA titers
Time frame: At Day 31
hSBA GMTs against each MenB indicator strain
Time frame: At Day 31 compared to Day 1
hSBA Geometric Mean Ratios (GMRs) against each MenB indicator strain
Time frame: At Day 31 compared to Day 1
Number of participants with hSBA titers >= to pre-defined limit of detection against each MenB indicator strain
Time frame: At Day 1
Number of participants with hSBA titers >= LLOQ against each MenB indicator strain
Time frame: At Day 1
hSBA GMTs against each MenB indicator strain
Time frame: At Day 1
Number of participants with solicited administration site events
The solicited administration site events include injection site pain, erythema (redness), swelling and induration.
Time frame: Day 1 (day of injection) to Day 7
Number of participants with solicited systemic events
The solicited systemic events include fever (temperature \>= 38.0°C), headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), nausea.
Time frame: Day 1 (day of injection) to Day 7
Number of participants with any unsolicited adverse events (AEs)
Time frame: Day 1 (day of injection) to Day 31
Number of participants with adverse events of special interest (AESI): arthritis, serious adverse events (SAEs), AEs leading to withdrawal
Time frame: Day 1 to Day 31 (throughout the study period)
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