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

January 29, 2019 updated by: Joanne Langley, Canadian Immunization Research Network

Preparedness for and Response to Meningococcal Outbreaks: a Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1: Accelerated Schedule
Biological: Bexsero®
Multicomponent meningococcal B vaccine
Biological: Havrix®
Hepatitis A vaccine
Active Comparator: Group 2: Standard Schedule
Biological: Bexsero®
Multicomponent meningococcal B vaccine
Biological: Havrix®
Hepatitis A vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA
Time Frame: Baseline to day 180

Immune responses will be measured:

  • Prior to 4CMenB vaccine (baseline)
  • To a single dose of 4CMenB vaccine 21 days post-immunization
  • 21 days after the second dose of an accelerated compared to a standard 4CMenB schedule
  • Six months after an accelerated 4CMenB vaccine schedule and a standard schedule
Baseline to day 180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of solicited general adverse events
Time Frame: Day 0-6

The number of participants in each vaccine group with each symptom day 0 to 6 after vaccine will be summarized. Each vaccine participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe.)

The following general AEs will be solicited:

  • Drowsiness
  • Fever
  • Nausea
  • Diarrhea
  • Vomiting
  • Generalized muscle aches
Day 0-6
Number of unsolicited general adverse events
Time Frame: Day 0-21
The number of participants in each vaccine group with each symptom day 0 to 21 after vaccine will be summarized. Each vaccine participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe.)
Day 0-21
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 reported in the accelerated vaccine schedule compared to a standard schedule
Time Frame: From injection to Day 180
From injection to Day 180
Number of solicited local and systemic injections site reactions
Time Frame: Day 0-6

The following local (injection-site) AEs will be solicited:

  • Pain at injection site
  • Redness at injection site
  • Swelling at injection site
Day 0-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canadian Immunization Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
University of Calgary
Dalhousie University
Université de Montréal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joanne M Langley, MD, MSc, FRCPC, IWK Health Centre, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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