Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-06-30

Brief Summary

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The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.

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Detailed Description

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A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0, 2 months schedule, to determine if the more compressed schedule is immunogenic, safe and tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect protection, and use of fewer public health resources for implementation.

Conditions

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Meningococcal Serogroup B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1: Accelerated Schedule

Group Type ACTIVE_COMPARATOR

Bexsero®

Intervention Type BIOLOGICAL

Multicomponent meningococcal B vaccine

Havrix®

Intervention Type BIOLOGICAL

Hepatitis A vaccine

Group 2: Standard Schedule

Group Type ACTIVE_COMPARATOR

Bexsero®

Intervention Type BIOLOGICAL

Multicomponent meningococcal B vaccine

Havrix®

Intervention Type BIOLOGICAL

Hepatitis A vaccine

Interventions

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Bexsero®

Multicomponent meningococcal B vaccine

Intervention Type BIOLOGICAL

Havrix®

Hepatitis A vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 17 to 25 years.
* Current or intended student at an educational setting in the 2015-2016 year.
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
* In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria

* Significant renal or hepatic impairment.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
* Previous bacteriologically confirmed N. meningitidis disease.
* Prior receipt of a meningococcal B vaccine
* Hypersensitivity to any vaccine component of products used in this study (see product monographs)
* Immunodeficiency or autoimmune disease

Minimum Eligible Age

17 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes