Meningococcal DiseasePhase 2NCT02140762
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
A Phase 2 study testing MenABCWY and MenACWY in people with Meningococcal Disease, run by Novartis Vaccines at 8 sites in United States.
Trial summary
Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- MenABCWY and MenACWY
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2014to Feb 2015
- Phase
- Phase 2
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
- Female subjects of childbearing potential must have a negative urine pregnancy test.
Who cannot join
- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
- Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Senders Pediatrics
Cleveland, Ohio, 44121
Accelovance, Inc
Huntsville, Alabama, 35802
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
Accelovance, Inc
Melbourne, Florida, 32935
Heartland Research Associates LLC
Newton, Kansas, 67114
Meridian Clinical Research
Omaha, Nebraska, 68134
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.
- Conditions
- Meningococcal Disease
- Being tested
- MenABCWY, Placebo, MenACWY
- Keywords
- Meningitis ABCWY, Adolescents, Vaccination, Meningococcal disease
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenABCWYBiological
Also called MenACWY conjugate combined with rMenB + OMV
Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.
PlaceboOther
Also called saline solution
0.5 mL saline solution (IM)
MenACWYBiological
Also called Menveo
Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.
| Study group | Role | What they receive |
|---|---|---|
| MenABCWY | Experimental | Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months Receives: Biological: MenABCWY |
| Placebo/MenACWY | Active comparator | Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months Receives: Other: Placebo; Biological: MenACWY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.
Least Square (LS)-mean computed from the generalized linear model.
Measured: One month after the second vaccination (month 3)
Secondary outcomes (27)
Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.
Least Square (LS)-mean computed from the generalized linear model.
Measured: Four months after the second vaccination (month 6)
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination
The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.
Least Square (LS)-mean computed from the generalized linear model.
Measured: One month after the second vaccination (month 3)
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.
The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.
Least Square (LS)-mean computed from the generalized linear model.
Measured: Four months after the second vaccination (month 6)
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.
Measured: Baseline, one month after second vaccination (month 3)
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at four months after the 2-dose vaccination series is reported.
Measured: Baseline, four months after second vaccination (month 6)
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA >= 1:4 and enc-hSBA titer >= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.
Measured: One month after the second vaccination (month 3)
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.
Measured: Four months after the second vaccination (month 6)
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.
Measured: One month after the second vaccination (month 3)
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.
Measured: Four months after the second vaccination (month 6)
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.
Measured: One month after the second vaccination (month 3)
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.
Measured: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at baseline(day 1) and one month after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.
Measured: At baseline(day 1) and One month after the second vaccination (month 3)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ against serogroups A, C, W, Y, at baseline(day 1) and one month after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.
Measured: At Baseline and One month after the second vaccination (month 3)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at four months after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively
Measured: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y at four months after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.
Measured: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at four months after the 2-dose vaccination series, is reported.
Measured: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y at four months after the 2-dose vaccination series.
Measured: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at one month after the 2-dose vaccination series, is reported.
Measured: One month after the second vaccination (month 3)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.
Measured: One month after the second vaccination (month 3)
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 2-fold rise in titer is defined as follows:
a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA
Measured: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 3-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 3-fold rise in titer is defined as follows:
a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.
Measured: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.
The 4-fold rise in titer is defined as follows:
a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.
Measured: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series.
The 2-fold rise in titer is defined as follows:
a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA.
Measured: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y at 1 and 4 months after the 2-dose vaccination series.
The 3-fold rise in titer is defined as follows:
a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA.
Measured: At Month 3 and Month 6 (one and four months after 2 doses of vaccination)
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series.
The 4-fold rise in titer is defined as follows:
a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA.
Measured: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.
Measured: From day 1 (6 hours) until day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs.
Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).
Measured: From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionFeb 2015
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 (4)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140762
- Sponsor's protocol ID
- V102_16
- Status last verified
- Aug 2018
- First submitted
- 6 May 2014
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Adu-Bobie J, Capecchi B, Serruto D, Rappuoli R, Pizza M. Two years into reverse vaccinology. Vaccine. 2003 Jan 30;21(7-8):605-10. doi: 10.1016/s0264-410x(02)00566-2.
PubMed 12531326Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26.
PubMed 21615224Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
PubMed 35257644Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.
PubMed 30061029
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
- ClinicalTrials.gov ID
- NCT02140762
- Acronym / sponsor ID
- V102_16
- Conditions
- Meningococcal Disease
- Keywords
- Meningitis ABCWY, Adolescents, Vaccination, Meningococcal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 26 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.
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 |
|---|---|---|
| MenABCWY | Experimental | Biological: MenABCWYSubjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months |
| Placebo/MenACWY | Active comparator | Other: Placebo, Biological: MenACWYSubjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
- Female subjects of childbearing potential must have a negative urine pregnancy test.
Key exclusion criteria (2 listed)
- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
- Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.
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 |
|---|---|---|
| MenABCWYAlso: MenACWY conjugate combined with rMenB + OMVSubjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months. | Biological | MenABCWY |
| PlaceboAlso: saline solution0.5 mL saline solution (IM) | Other | Placebo/MenACWY |
| MenACWYAlso: MenveoSubjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months. | Biological | Placebo/MenACWY |
Primary outcome
Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.
Time frame: One month after the second vaccination (month 3)
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
27 secondary outcomes
Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.
Time frame: Four months after the second vaccination (month 6)
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination
Time frame: One month after the second vaccination (month 3)
Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.
Time frame: Four months after the second vaccination (month 6)
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
Time frame: Baseline, one month after second vaccination (month 3)
Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject
Time frame: Baseline, four months after second vaccination (month 6)
Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series
Time frame: One month after the second vaccination (month 3)
Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series
Time frame: Four months after the second vaccination (month 6)
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
Time frame: One month after the second vaccination (month 3)
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
Time frame: Four months after the second vaccination (month 6)
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y
Time frame: One month after the second vaccination (month 3)
HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y
Time frame: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.
Time frame: At baseline(day 1) and One month after the second vaccination (month 3)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series
Time frame: At Baseline and One month after the second vaccination (month 3)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
Time frame: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.
Time frame: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.
Time frame: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series
Time frame: Four months after the second vaccination (month 6)
Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Time frame: One month after the second vaccination (month 3)
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series
Time frame: One month after the second vaccination (month 3)
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.
Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.
Time frame: At Month 3 and Month 6 (one and four months after 2 doses of vaccination)
Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.
Time frame: At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Time frame: From day 1 (6 hours) until day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs.
Time frame: From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12531326Adu-Bobie J, Capecchi B, Serruto D, Rappuoli R, Pizza M. Two years into reverse vaccinology. Vaccine. 2003 Jan 30;21(7-8):605-10. doi: 10.1016/s0264-410x(02)00566-2.
- Background: PubMed 21615224Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011 Jul;11(7):969-85. doi: 10.1517/14712598.2011.585965. Epub 2011 May 26.
- Derived from this study: PubMed 35257644Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
- Derived from this study: PubMed 30061029Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenABCWY and MenACWY in people with Meningococcal Disease, run by Novartis Vaccines at 8 sites in United States.
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 2 inclusion and 2 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Jun 2018). 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 Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination. (time frame: One month after the second vaccination (month 3)). 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 NCT02140762, which also lists 4 linked publications.
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 12 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.