Status:
ACTIVE_NOT_RECRUITING
A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Meningitis
Eligibility:
All Genders
10-20 years
Phase:
PHASE3
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 adul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2025
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06995430
Start Date
July 7 2025
End Date
December 10 2025
Last Update
November 24 2025
Active Locations (17)
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1
GSK Investigational Site
Espoo, Finland, 02230
2
GSK Investigational Site
Helsinki, Finland, 00100
3
GSK Investigational Site
Jarvenpaa, Finland, 04400
4
GSK Investigational Site
Kokkola, Finland, 67100