Novartis Vaccine and Diagnostics Carriage Trial

Novartis

Status and phase: Completed; Phase 3

Conditions: N. Meningitidis Carriage

Treatments: Biological: MenACWY-CRM conjugate vaccine; Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ); Biological: Japanese Encephalitis vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214850

V72_29

Details and patient eligibility

About

The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population.

Enrollment: 2,968 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects, 18-24 years of age who provided written informed consent at the time of enrollment;
• Subjects who were available for all the visits scheduled in the study;
• Subjects who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion criteria

• History of any serogroup B meningococcal vaccine administration;
• Current or previous, confirmed or suspected disease caused by N. meningitidis;
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
• Significant acute or chronic infection within the previous 7 days or fever (defined as oral temperature ≥38ºC) within the previous day;
• Antibiotics within 3 days (72 hours) prior to enrollment;
• Pregnancy or nursing (breastfeeding) mothers;
• Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the 12 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence were considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry;
• Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
• Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body were allowed]; use of immunostimulants;
• 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;
• Participation in another clinical trial within the last 90 days or planned for during study;
• Family members and household members of research staff;
• Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,968 participants in 3 patient groups

rMenB+OMV

Experimental group

Description:

Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart

Treatment:

Biological: Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)

MenACWY

Experimental group

Description:

Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart

Treatment:

Biological: MenACWY-CRM conjugate vaccine

Control

Active Comparator group

Description:

Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart

Treatment:

Biological: Japanese Encephalitis vaccine