Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

June 11, 2020 updated by: Novartis Vaccines

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

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Izabelin (Warszawa), Poland, 05-080
        • Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41
      • Kraków, Poland, 31-223
        • NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12
      • Kraków, Poland, 31-422
        • NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15
      • Warszawa, Poland, 01-809
        • Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80
      • Wrocław, Poland, 50-354
        • Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615
    • California
      • Madera, California, United States, 93637
        • Madera Family Medical Group,1111 West 4th Street
      • Paramount, California, United States, 90723
        • Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research, 201 south 5th street
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2
    • Ohio
      • Huber Heights, Ohio, United States, 45424
        • Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C
      • Kettering, Ohio, United States, 45420
        • Ohio Pediatric Research Association, 1775 Delco Park Drive
    • Tennessee
      • Lebanon, Tennessee, United States, 37087
        • Focus Research Group,201 Signature Place

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ABCWY+OMV
Subjects 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.
Biological: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
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.
EXPERIMENTAL: ABCWY+qOMV
Subjects 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.
Biological: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
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.
ACTIVE_COMPARATOR: rMenB+OMV
Subjects in this group received two doses of "Meningococcal (group B) multicomponent recombinant adsorbed vaccine",administered two months apart.
Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
ACTIVE_COMPARATOR: MenACWY
Subjects 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.
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.
Time Frame: One month after the second vaccination (Day 91)

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.
Time Frame: One month after the second vaccination (Day 91)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Day 1 and one month after second vaccination (Day 91)
Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY 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.
Time Frame: Day 1 and one month after the second vaccination (Day 91)
The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY 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.
Time Frame: Day 1 and one month after the second vaccination (Day 91)
The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV 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.
Time Frame: One month after the second vaccination (Day 91)

The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.

4-fold increase is defined as follows;

for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase.
One month after the second vaccination (Day 91)
The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Time Frame: Day 1 and one month after the second vaccination (Day 91)
The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Day 1 and one month after the second vaccination (Day 91)
The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Time Frame: One month after the second vaccination/prevaccination (Day 91/day 1)
The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
One month after the second vaccination/prevaccination (Day 91/day 1)
The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.
Time Frame: Day 1 through day 7 after any vaccination
The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.
Day 1 through day 7 after any vaccination
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.
Time Frame: Throughout the study ( Day 1 to Day 241)
The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.
Throughout the study ( Day 1 to Day 241)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (ESTIMATE)

January 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V102_03
  • 2010-023523-23 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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