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

NCT ID: NCT01272180

Last Updated: 2020-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Invasive Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.

Intervention Type BIOLOGICAL

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.

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.

Group Type EXPERIMENTAL

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.

Intervention Type BIOLOGICAL

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.

rMenB+OMV

Subjects in this group received two doses of "Meningococcal (group B) multicomponent recombinant adsorbed vaccine",administered two months apart.

Group Type ACTIVE_COMPARATOR

Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

Intervention Type BIOLOGICAL

Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

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.

Group Type ACTIVE_COMPARATOR

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Intervention Type BIOLOGICAL

One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Interventions

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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.

Intervention Type BIOLOGICAL

Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.

Intervention Type 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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Alabama Clinical Therapeutics, 806 St. Vincent's Drive, Suite 615

Birmingham, Alabama, United States

Site Status

Madera Family Medical Group,1111 West 4th Street

Madera, California, United States

Site Status

Center for Clinical Trials LLC, 16660 Paramount Blvd, Suite 301

Paramount, California, United States

Site Status

Kentucky Pediatric/Adult Research, 201 south 5th street

Bardstown, Kentucky, United States

Site Status

Bluegrass Clinical Research Inc.5512 Bardstown Road, Suite 2

Louisville, Kentucky, United States

Site Status

Ohio Pediatric Research Association, 7371 Brandt Pike, Suite C

Huber Heights, Ohio, United States

Site Status

Ohio Pediatric Research Association, 1775 Delco Park Drive

Kettering, Ohio, United States

Site Status

Focus Research Group,201 Signature Place

Lebanon, Tennessee, United States

Site Status

Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna,,Juniperus"s.c, ul.Kościuszki 41

Izabelin (Warszawa), , Poland

Site Status

NZOZ HIPOKRATES II.sp.zo.o, ul.Pachonskiego 12

Krakow, , Poland

Site Status

NZOZ PRAKTIMED Sp.zo.o, ul.Strzelców 15

Krakow, , Poland

Site Status

Klinika Pediatrii Centrum Medycznego Kształcenia PodyplomowegoSzpital Bielański, ul. Cegłowska 80

Warsaw, , Poland

Site Status

Katedra i Klinika Pediatrii i Chorób Infekcyjnych, ul.O.Bujwida 44

Wroclaw, , Poland

Site Status

Countries

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United States Poland

References

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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.

Reference Type DERIVED
PMID: 29329168 (View on PubMed)

Other Identifiers

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2010-023523-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V102_03

Identifier Type: -

Identifier Source: org_study_id

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