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

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

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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.