Meningococcal DiseasePhase 3NCT01478347
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
A Phase 3 study testing Recombinant meningococcal B + OMV NZ in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 1 site in Italy.
Trial summary
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers). In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease, Meningococcal Meningitis
- What is being tested?
- Recombinant meningococcal B + OMV NZ
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Nov 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
- Able to comprehend and follow all required study procedures;
- Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
- In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
- Who were or might be routinely exposed to N. meningitidis cultures
- 18 - 65 years of age inclusive;
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- At least 50 kg weight;
- Blood pressure within the following ranges: Systolic 110-180; Diastolic 60-100;
- Regular pulse rate (50-90 beats per minute) - exceptions are acceptable upon investigator's judgment;
- Hematocrit higher than: 32% for women and 35% for males;
- Visit 3 sera suitable as control for standardization of the SBA as confirmed by the central laboratory.
Who cannot join
- History of any serogroup B meningococcal vaccine administration
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
- Pregnancy or nursing (breastfeeding) mothers;
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry;
- Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
- Receipt of any chronic immunosuppressive therapy
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- Receipt of any chronic immunostimulants
- Immune deficiency disorder, or known HIV infection
- Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
- History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study.
- Any significant chronic infection.
- Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Known or suspected autoimmune disease;
- Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, diabetes, cardiovascular, renal, hepatic, immunological, metabolic, urogenital, hematological, gastrointestinal, central nervous system disease);
- Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
- History of fainting or seizure episodes;
- Pregnancy
- Any significant chronic infection;
- Significant acute infections within the previous 2 weeks;
- Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
- Receipt of any chronic immunosuppressive therapy; Receipt of any chronic immunostimulants; Immune deficiency disorder, or known HIV infection;
- Significant acute illness within the previous 7 days or body temperature 38.0 C within the previous 3 days;
- Receipt of systemic antibiotics within the previous 3 days (72 hours).
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Medicina Interna 2, Azienda Ospedaliera Universitaria Senese
Siena, 53100
About this study
Official title: A Phase 3b, Single-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-risk Adults
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Being tested
- Recombinant meningococcal B + OMV NZ
- Keywords
- Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant meningococcal B + OMV NZBiological
2 injections 2 months apart
| Study group | Role | What they receive |
|---|---|---|
| rMenB+OMV NZ | Experimental | Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant meningococcal B (rMenB) + Outer Membrane Vesicle (OMV NZ) vaccine, 2 months apart, in part I of the study, were enrolled for optional blood draws and safety follow-up in part II of the study. Receives: Biological: Recombinant meningococcal B + OMV NZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.
The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.
Measured: Day 1 to day 91
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).
The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.
Measured: Day 92 to day 331
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meningococcal DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478347
- Sponsor's protocol ID
- V72_37
- Status last verified
- Mar 2015
- First submitted
- 21 Nov 2011
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Single-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-risk Adults
- ClinicalTrials.gov ID
- NCT01478347
- Acronym / sponsor ID
- V72_37
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Keywords
- Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
In the second part of the study additional blood samples of high responding vaccinated subjects will be collected for the purpose of generating a control serum panel for the human serum bactericidal assay (hSBA) tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rMenB+OMV NZ | Experimental | Biological: Recombinant meningococcal B + OMV NZHealthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant meningococcal B (rMenB) + Outer Membrane Vesicle (OMV NZ) vaccine, 2 months apart, in part I of the study, were enrolled for optional blood draws and safety follow-up in part II of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
- Able to comprehend and follow all required study procedures;
- Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
- In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
- Who were or might be routinely exposed to N. meningitidis cultures
Key exclusion criteria (23 listed)
- History of any serogroup B meningococcal vaccine administration
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
- Pregnancy or nursing (breastfeeding) mothers;
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least one months prior to study entry;
- Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
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 |
|---|---|---|
| Recombinant meningococcal B + OMV NZ2 injections 2 months apart | Biological | rMenB+OMV NZ |
Primary outcome
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.
Time frame: Day 1 to day 91
The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).
Time frame: Day 92 to day 331
The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Vaccines study chair
Novartis Vaccines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant meningococcal B + OMV NZ in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 1 site in Italy.
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 11 inclusion and 23 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 27 Mar 2015. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. (time frame: Day 1 to day 91). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2015.