Meningitis
Conditions
Keywords
Meningitis, booster dose, Bexsero, Immune response
Brief summary
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.
Interventions
BIOLOGICALrMenB+OMV NZ vaccine
1 dose in the Primed group or 2 doses in the Naive group.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an Open-Label study.
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply: For primed group only: • Participated who were primed with rMenB + OMV NZ in only either 3+1 or 2+1 schedule during the first 2 years of life as confirmed by electronic or paper vaccination record. OR For naïve group only: • Electronic or paper vaccination record confirmed participant who has never received any group B meningococcal vaccine and is recruited in the same country as primed participants. For all participants: * Participants and/or participants' parent(s)/ legally acceptable representative(s) (LAR\[s\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol * Written or witnessed/thumb printed informed consent obtained from the participant / parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure. * Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure. Note: For age 10-16 years, parents or LAR to give consent along with participants, based on country regulations for participants and for \>16/18 to 20 years, participants give consent independent of parents/LARs, or as per local country regulations. * A male or female between, and including, 10 and 20 years of age at the time of the first study intervention administration. * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral ovariectomy. * Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study intervention administration, and * has agreed to continue adequate contraception during the entire study treatment period.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: Medical conditions * Current or previous, confirmed or suspected disease caused by N. meningitidis. * Known exposure to an individual with laboratory confirmed N. meningitidis infection, within 60 days prior to enrollment. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. * Medical conditions representing a contraindication to intramuscular vaccination and blood draws. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention during the period beginning 30 days before the first dose of study intervention (Day -29 to Day 1), or their planned use during the study period. * Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * Within 90 days prior to study intervention administration: for corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants or \>= 0.5 mg/kg/day with maximum of 20 milligram (mg)/day for pediatric participants. Inhaled and topical steroids are allowed. * Within 90 days prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. * Administration of immunoglobulins and/or any blood products or plasma derivatives within 180 days prior to study intervention administration and/or planned use at any time up to the end of the study. For primed group only: • Participants who received additional dose(s) of group B meningococcal vaccine other than 2+1 or 3+1 schedule prior to study intervention administration. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/vaccine/invasive medical device). Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain | At Day 31 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with hSBA titers greater than or equal (>=) to pre-defined limit of detection against each MenB indicator strain | At Day 31 | — |
| Number of participants with hSBA titers >= lower limit of quantification (LLOQ) against each MenB indicator strain | At Day 31 | — |
| Number of participants with four-fold increase in hSBA titers | At Day 31 | — |
| hSBA GMTs against each MenB indicator strain | At Day 31 compared to Day 1 | — |
| hSBA Geometric Mean Ratios (GMRs) against each MenB indicator strain | At Day 31 compared to Day 1 | — |
| Number of participants with hSBA titers >= to pre-defined limit of detection against each MenB indicator strain | At Day 1 | — |
| Number of participants with hSBA titers >= LLOQ against each MenB indicator strain | At Day 1 | — |
| Number of participants with solicited administration site events | Day 1 (day of injection) to Day 7 | The solicited administration site events include injection site pain, erythema (redness), swelling and induration. |
| Number of participants with solicited systemic events | Day 1 (day of injection) to Day 7 | The solicited systemic events include fever (temperature \>= 38.0°C), headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), nausea. |
| Number of participants with any unsolicited adverse events (AEs) | 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 | Day 1 to Day 31 (throughout the study period) | — |
Countries
Finland, Italy, Spain, United Kingdom
Outcome results
None listed