NCT06995430已完成3 期
A Phase 3b, Open-Label, Multi-Center Study to Assess the Immune Response And Safety of The Meningococcal Group B Vaccine Rmenb+Omv Nz When Administered to Healthy Participants Aged 10 To 20 Years Old, Who Were Primed During the First 2 Years Of Life
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 18
- 主要终点
- hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an Open-Label study.
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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 exclusion criteria
- •Pregnant or lactating female participant.
- •Any study personnel or their immediate dependents, family, or household member.
- •Child in care.
研究组 & 干预措施
Primed group
Experimental
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.
干预措施: rMenB+OMV NZ vaccine (Biological)
Naive group
Active Comparator
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.
干预措施: rMenB+OMV NZ vaccine (Biological)
结局指标
主要结局
hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain
时间窗: At Day 31
次要结局
- 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)
- hSBA GMTs against each MenB indicator strain(At Day 31 compared to Day 1)
- Number of participants with solicited administration site events(Day 1 (day of injection) to Day 7)
- Number of participants with solicited systemic events(Day 1 (day of injection) to Day 7)
- 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))
研究者
研究点 (18)
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