Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations
2 other identifiers
interventional
484
2 countries
13
Brief Summary
This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
September 26, 2014
CompletedJune 16, 2020
March 1, 2019
2 months
January 6, 2011
January 31, 2014
June 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.
Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer. Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).
One month after the second vaccination (Day 91)
Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.
The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.
One month after the second vaccination (Day 91)
Secondary Outcomes (8)
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Day 1 and one month after second vaccination (Day 91)
The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Day 1 and one month after the second vaccination (Day 91)
Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Day 1 and one month after the second vaccination (Day 91)
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
One month after the second vaccination (Day 91)
The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Day 1 and one month after the second vaccination (Day 91)
- +3 more secondary outcomes
Study Arms (4)
ABCWY+OMV
EXPERIMENTALSubjects in this group received two doses of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine" plus Outer Membrane Vesicles (OMV) administered two months apart.
ABCWY+qOMV
EXPERIMENTALSubjects in this group received two doses of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine" plus one quarter dose of Outer Membrane Vesicles (qOMV) administered two months apart.
rMenB+OMV
ACTIVE COMPARATORSubjects in this group received two doses of "Meningococcal (group B) multicomponent recombinant adsorbed vaccine",administered two months apart.
MenACWY
ACTIVE COMPARATORSubjects in this group received a dose of placebo followed by one dose of "Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine" administered two months later.
Interventions
Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.
Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.
Eligibility Criteria
You may qualify if:
- Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.
You may not qualify if:
- History of any meningococcal vaccine administration;
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Pregnant 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, 35205, United States
Madera Family Medical Group,1111 West 4th Street
Madera, California, 93637, United States
Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301
Paramount, California, 90723, United States
Kentucky Pediatric/Adult Research, 201 south 5th street
Bardstown, Kentucky, 40004, United States
Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2
Louisville, Kentucky, 40291, United States
Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C
Huber Heights, Ohio, 45424, United States
Ohio Pediatric Research Association, 1775 Delco Park Drive
Kettering, Ohio, 45420, United States
Focus Research Group,201 Signature Place
Lebanon, Tennessee, 37087, United States
Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41
Izabelin (Warszawa), 05-080, Poland
NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12
Krakow, 31-223, Poland
NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15
Krakow, 31-422, Poland
Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80
Warsaw, 01-809, Poland
Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44
Wroclaw, 50-354, Poland
Related Publications (1)
Szenborn L, Block SL, Jackowska T, Konior R, D'Agostino D, Smolenov I, Toneatto D, Welsch JA. Immune Responses to Booster Vaccination With Meningococcal ABCWY Vaccine After Primary Vaccination With Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study. Pediatr Infect Dis J. 2018 May;37(5):475-482. doi: 10.1097/INF.0000000000001896.
PMID: 29329168DERIVED
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 7, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
September 1, 2012
Last Updated
June 16, 2020
Results First Posted
September 26, 2014
Record last verified: 2019-03