Meningococcal Serogroup BPhase 4NCT02583412
Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults
A Phase 4 study testing Bexsero® and Havrix® in people with Meningococcal Serogroup B, run by Canadian Immunization Research Network at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Serogroup B
- What is being tested?
- Bexsero® and Havrix®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to 30 Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Meningococcal Serogroup B
- Being tested
- Bexsero®, Havrix®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bexsero®Biological
Multicomponent meningococcal B vaccine
Havrix®Biological
Hepatitis A vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Accelerated Schedule | Active comparator | Not described Receives: Biological: Bexsero®; Biological: Havrix® |
| Group 2: Standard Schedule | Active comparator | Not described Receives: Biological: Bexsero®; Biological: Havrix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA
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
Measured: Baseline to day 180
Secondary outcomes (4)
Number of solicited general adverse events
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
Measured: Day 0-6
Number of unsolicited general adverse events
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.)
Measured: 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
Measured: From injection to Day 180
Number of solicited local and systemic injections site reactions
The following local (injection-site) AEs will be solicited:
- Pain at injection site
- Redness at injection site
- Swelling at injection site
Measured: Day 0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal Serogroup BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Immunization Research Network
- Sponsor type
- Research network
- Collaborators
- University of British Columbia, University of Calgary, Université de Montréal, Dalhousie University
- Responsible party
- Principal investigator, Joanne Langley, Canadian Immunization Research Network
- Investigators
- Joanne M Langley, MD, MSc, FRCPC, Principal investigator, IWK Health Centre, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583412
- Sponsor's protocol ID
- CT11
- Status last verified
- Jan 2019
- First submitted
- 4 Sep 2015
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharkey K, Beernink PT, Langley JM, Gantt S, Quach C, Dold C, Liu Q, Galvan M, Granoff DM. Anti-Factor H Antibody Reactivity in Young Adults Vaccinated with a Meningococcal Serogroup B Vaccine Containing Factor H Binding Protein. mSphere. 2019 Jul 3;4(4):e00393-19. doi: 10.1128/mSphere.00393-19.
PubMed 31270173
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02583412
- Acronym / sponsor ID
- CT11
- Conditions
- Meningococcal Serogroup B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Canadian Immunization Research NetworkResearch network
- Collaborators
- University of British Columbia, University of Calgary, Université de Montréal, Dalhousie University
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Accelerated Schedule | Active comparator | Biological: Bexsero®, Biological: Havrix® |
| Group 2: Standard Schedule | Active comparator | Biological: Bexsero®, Biological: Havrix® |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bexsero®Multicomponent meningococcal B vaccine | Biological | Group 1: Accelerated Schedule, Group 2: Standard Schedule |
| Havrix®Hepatitis A vaccine | Biological | Group 1: Accelerated Schedule, Group 2: Standard Schedule |
Primary outcome
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
4 secondary outcomes
Number of solicited general adverse events
Time frame: Day 0-6
Number of unsolicited general adverse events
Time frame: 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
Number of solicited local and systemic injections site reactions
Time frame: Day 0-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Derived from this study: PubMed 31270173Sharkey K, Beernink PT, Langley JM, Gantt S, Quach C, Dold C, Liu Q, Galvan M, Granoff DM. Anti-Factor H Antibody Reactivity in Young Adults Vaccinated with a Meningococcal Serogroup B Vaccine Containing Factor H Binding Protein. mSphere. 2019 Jul 3;4(4):e00393-19. doi: 10.1128/mSphere.00393-19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne M Langley, MD, MSc, FRCPC principal investigator
IWK Health Centre, Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bexsero® and Havrix® in people with Meningococcal Serogroup B, run by Canadian Immunization Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA (time frame: Baseline to day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.