A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Partic… (NCT06995430) | Clinical Trial Compass
CompletedPhase 3
A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old)
Finland312 participantsStarted 2025-07-07
Plain-language 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.
Who can participate
Age range10 Years – 20 Years
SexALL
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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…
What they're measuring
1
hSBA Geometric mean titers (GMTs) ratio against each MenB indicator strain