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

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Novartis

Status and phase

Completed
Phase 2

Conditions

Invasive Meningococcal Disease

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01272180
V102_03
2010-023523-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

484 patients

Sex

All

Ages

10 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

484 participants in 4 patient groups

ABCWY+OMV
Experimental group
Description:
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.
Treatment:
Biological: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
ABCWY+qOMV
Experimental group
Description:
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.
Treatment:
Biological: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
rMenB+OMV
Active Comparator group
Description:
Subjects in this group received two doses of "Meningococcal (group B) multicomponent recombinant adsorbed vaccine",administered two months apart.
Treatment:
Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
MenACWY
Active Comparator group
Description:
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.
Treatment:
Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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