Meningococcal DiseasePhase 3NCT01423084
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
A Phase 3 study testing Serogroup B meningococcal vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis at 13 sites in 2 countries.
Trial summary
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease, Meningococcal Meningitis
- What is being tested?
- Serogroup B meningococcal vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Aug 2011to Dec 2011
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
- 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 cannot join
- History of any serogroup B meningococcal vaccination
- Current or previous, confirmed or suspected disease caused by N. meningitidis
- Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
- Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
- Antibiotic use within 3 days (72 hours) prior to enrollment
- Pregnancy or nursing (breastfeeding) mothers
Show all 10Show fewer
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry
- Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system
- Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada7 sites
Albion Finch Medical Centre, 1620 Albion Road, Suite 106
Etobicoke, Ontario, M9V 4B4
Medicor Research Inc, 359 Riverside, Suite 200
Greater Sudbury, Ontario, P3E 1H5
TASC Research Services, 1-15243 91st Avenue
Surrey, British Columbia, V3R 8P8
SKDS Research Inc, 221-679 Davis Dr.Newmarket
Toronto, Ontario, L3Y 5G8
Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540
Toronto, Ontario, M5G 1N8
Colchester Regional Hospital Colchester Research Group, 68 Robie Street
Truro, Nova Scotia, B2N 1L2
Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301
Woodstock, Ontario, N4S 5P5
Australia6 sites
Telethon Institute for Child Heath Research-cnr
Hamilton Street and Roberts Road-Subiaco, Western Australia, 6008
Royal Children's Hospital
Herston, Queensland, 4029
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre
Kippa-Ring, Queensland, 4021
Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne
Melbourne, Victoria, 3010
Women's and Children's Hospital, 72 King William Road
North Adelaide, South Australia, 5006
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street
Sherwood, Queensland, 4075
About this study
Official title: A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
Read the detailed description
Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Being tested
- Serogroup B meningococcal vaccine
- Keywords
- Meningococcal Meningitis, prevention, vaccination, adolescents
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serogroup B meningococcal vaccineBiological
All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2.
A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination
| Study group | Role | What they receive |
|---|---|---|
| MenB Lot 1 | Experimental | MenB vaccine Lot 1: 2 doses administered 1 month apart Receives: Biological: Serogroup B meningococcal vaccine |
| MenB Lot 2 | Active comparator | MenB vaccine Lot 2: 2 doses administered 1 month apart Receives: Biological: Serogroup B meningococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
Measured: One month after the second vaccination (day 61)
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Measured: One month after the second vaccination (day 61)
Secondary outcomes (11)
Percentage of Subjects in Each Lot With hSBA ≥ 1:5
The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group
Measured: One month after the second vaccination (day 61)
Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.
The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).
Measured: One month after the second vaccination (day 61)
Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
Measured: One month after the second vaccination (day 61)
hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
Measured: Two weeks after the second vaccination (day 45)
GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.
meningitidis serogroup B reference strains at two weeks after last vaccination.
Measured: Two weeks after the second vaccination (day 45)
Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.
The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.
Measured: Two weeks after the second vaccination (day 45)
ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
Measured: Two weeks after the second vaccination (day 45)
GMR of ELISA GMCs Against Antigen 287-953 at Day 45.
The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).
Measured: Two weeks after the second vaccination (day 45)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
Measured: From day 1 to day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs
Number of subjects reporting any Unsolicited AEs after any vaccination.
Measured: From day 1 to day 7 after any vaccination.
Number of Subjects Reporting SAEs and AE Leading to Withdrawal
Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.
Measured: Throughout the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423084
- Sponsor's protocol ID
- V72_41
- Status last verified
- Feb 2015
- First submitted
- 23 Aug 2011
- Last updated
- 20 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Perrett KP, McVernon J, Richmond PC, Marshall H, Nissen M, August A, Percell S, Toneatto D, Nolan T. Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study. Vaccine. 2015 Sep 22;33(39):5217-24. doi: 10.1016/j.vaccine.2015.06.103. Epub 2015 Jul 29.
PubMed 26232542
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
- ClinicalTrials.gov ID
- NCT01423084
- Acronym / sponsor ID
- V72_41
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Keywords
- Meningococcal Meningitis, prevention, vaccination, adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Posted 20 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
Detailed description
Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MenB Lot 1 | Experimental | Biological: Serogroup B meningococcal vaccineMenB vaccine Lot 1: 2 doses administered 1 month apart |
| MenB Lot 2 | Active comparator | Biological: Serogroup B meningococcal vaccineMenB vaccine Lot 2: 2 doses administered 1 month apart |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
- 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.
Key exclusion criteria (10 listed)
- History of any serogroup B meningococcal vaccination
- Current or previous, confirmed or suspected disease caused by N. meningitidis
- Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
- Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
- Antibiotic use within 3 days (72 hours) prior to enrollment
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 |
|---|---|---|
| Serogroup B meningococcal vaccineAll subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination | Biological | MenB Lot 1, MenB Lot 2 |
Primary outcome
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
Time frame: One month after the second vaccination (day 61)
Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953
Time frame: One month after the second vaccination (day 61)
The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
11 secondary outcomes
Percentage of Subjects in Each Lot With hSBA ≥ 1:5
Time frame: One month after the second vaccination (day 61)
Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.
Time frame: One month after the second vaccination (day 61)
Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953
Time frame: One month after the second vaccination (day 61)
hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
Time frame: Two weeks after the second vaccination (day 45)
GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
Time frame: Two weeks after the second vaccination (day 45)
Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.
Time frame: Two weeks after the second vaccination (day 45)
ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.
Time frame: Two weeks after the second vaccination (day 45)
GMR of ELISA GMCs Against Antigen 287-953 at Day 45.
Time frame: Two weeks after the second vaccination (day 45)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Time frame: From day 1 to day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs
Time frame: From day 1 to day 7 after any vaccination.
Number of Subjects Reporting SAEs and AE Leading to Withdrawal
Time frame: Throughout the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26232542Perrett KP, McVernon J, Richmond PC, Marshall H, Nissen M, August A, Percell S, Toneatto D, Nolan T. Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study. Vaccine. 2015 Sep 22;33(39):5217-24. doi: 10.1016/j.vaccine.2015.06.103. Epub 2015 Jul 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serogroup B meningococcal vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis at 13 sites in 2 countries.
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 3 inclusion and 10 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 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Australia. 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 20 Feb 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?
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. (time frame: One month after the second vaccination (day 61)). 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?
On the ClinicalTrials.gov record for NCT01423084, 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 20 Feb 2015.