Meningococcal DiseasePhase 3NCT01973218
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
A Phase 3 study testing Meningococcal B Recombinant vaccine rMenB+OMV NZ and Meningococcal ACWY-CRM conjugate vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 7 sites in South Korea.
Trial summary
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years. 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
- What is being tested?
- Meningococcal B Recombinant vaccine rMenB+OMV NZ and Meningococcal ACWY-CRM conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Nov 2013to Apr 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
- 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;
- With a negative urine pregnancy test (for female subjects only).
Who cannot join
- History of any meningococcal vaccine administration;
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
- Pregnancy or nursing (breastfeeding) mothers;
- Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
- Any serious chronic or progressive disease;
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- Family members and household members of research staff;
- Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
- Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;
- Antibiotics within 6 days prior to enrollment;
- Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;
- 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;
- Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;
- Participation in another clinical trial within the last 90 days or planned for during study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu
Ansan-si, Gyeonggi-do, 425-707
07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil
Bundang-gu, Seongnam, 463-707
02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu
Incheon, 400-711
01 Seoul National University Hospital 101 Daehang-ro,
Jongno-gu, Seoul, 110-744,
06 Kosin University Gospel Hospital 34, amnam-dong
Seo-gu, Busan, 602-702
03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong
Yangch’ŏn-gu, Seoul, 158-710
04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup
Yangsan, Gyeongsangnam-do, 626-770
About this study
Official title: A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.
- Conditions
- Meningococcal Disease
- Being tested
- Meningococcal B Recombinant vaccine rMenB+OMV NZ, Placebo, Meningococcal ACWY-CRM conjugate vaccine
- Keywords
- Meningitis, adolescents, Meningococcal B
- Medical subject headings
- Meningococcal Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal B Recombinant vaccine rMenB+OMV NZBiological
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.
PlaceboBiological
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Meningococcal ACWY-CRM conjugate vaccineBiological
Also called Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
| Study group | Role | What they receive |
|---|---|---|
| rMenB | Experimental | Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. Receives: Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ |
| Placebo/MenACWY | Active comparator | Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. Receives: Biological: Placebo; Biological: Meningococcal ACWY-CRM conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
Measured: Day 1 and Day 61
Secondary outcomes (7)
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.
Measured: Day 1 and Day 61
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.
Measured: Day 61/ Day 1
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.
Measured: Day 61
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.
Measured: Day 1 and Day 61
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.
Measured: Day 61/Day 1
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Measured: Day 1 through day 7 after each vaccination
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
Measured: Day 1 through Day 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 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
- NCT01973218
- Sponsor's protocol ID
- V72_42
- Other IDs
- 20130090378
- Status last verified
- Oct 2015
- First submitted
- 25 Oct 2013
- Last updated
- 30 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, Casula D, Bhusal C, Arora AK. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 Jan 28.
PubMed 26826544
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea
- ClinicalTrials.gov ID
- NCT01973218
- Acronym / sponsor ID
- V72_42
- Conditions
- Meningococcal Disease
- Keywords
- Meningitis, adolescents, Meningococcal B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Oct 2013 (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 purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rMenB | Experimental | Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZSubjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. |
| Placebo/MenACWY | Active comparator | Biological: Placebo, Biological: Meningococcal ACWY-CRM conjugate vaccineSubjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
- 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;
- With a negative urine pregnancy test (for female subjects only).
Key exclusion criteria (15 listed)
- History of any meningococcal vaccine administration;
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
- Pregnancy or nursing (breastfeeding) mothers;
- Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
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 |
|---|---|---|
| Meningococcal B Recombinant vaccine rMenB+OMV NZSubjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months. | Biological | rMenB |
| PlaceboSubjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months. | Biological | Placebo/MenACWY |
| Meningococcal ACWY-CRM conjugate vaccineAlso: Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months. | Biological | Placebo/MenACWY |
Primary outcome
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
Time frame: Day 1 and Day 61
Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.
7 secondary outcomes
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
Time frame: Day 1 and Day 61
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Time frame: Day 61/ Day 1
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
Time frame: Day 61
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
Time frame: Day 1 and Day 61
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
Time frame: Day 61/Day 1
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
Time frame: Day 1 through day 7 after each vaccination
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
Time frame: Day 1 through Day 61
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26826544Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, Casula D, Bhusal C, Arora AK. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 Jan 28.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal B Recombinant vaccine rMenB+OMV NZ and Meningococcal ACWY-CRM conjugate vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 7 sites in South Korea.
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 4 inclusion and 15 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 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. (time frame: Day 1 and Day 61). 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 NCT01973218, 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 30 Oct 2015.