A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old)
- Conditions
- Meningitis
- Interventions
- Biological: rMenB+OMV NZ vaccine
- Registration Number
- NCT06995430
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 312
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.
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A male or female between, and including, 10 and 20 years of age at the time of the first study intervention administration.
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Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy.
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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.
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
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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.
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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.
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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 exclusion criteria
- Pregnant or lactating female participant.
- Any study personnel or their immediate dependents, family, or household member.
- Child in care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primed group rMenB+OMV NZ vaccine Participants who were primed with rMenB+OMV NZ in a 2+1 or 3+1 schedule during the first 2 years of life will receive 1 dose of rMenB+OMV NZ at Day 1. Naive group rMenB+OMV NZ vaccine Participants who are group B-meningococcal-vaccine-naive within the same age range as the primed group receive 2 doses of rMenB+OMV NZ at Day 1 and Day 31.
- Primary Outcome Measures
Name Time Method hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain At Day 31
- Secondary Outcome Measures
Name Time Method 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 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)