Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: MenABCWY; Biological: MenACWY; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02140762

V102_16

Details and patient eligibility

About

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Enrollment: 305 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
• Female subjects of childbearing potential must have a negative urine pregnancy test.

Exclusion criteria

• Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
• Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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305 participants in 2 patient groups

MenABCWY

Experimental group

Description:

Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months

Treatment:

Biological: MenABCWY

Placebo/MenACWY

Active Comparator group

Description:

Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months

Treatment:

Biological: MenACWY

Other: Placebo