A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Meningitis; Meningococcal Disease

Treatments: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018732

V59P6E1

Details and patient eligibility

About

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Full description

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Enrollment: 155 patients

Sex: All

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
• Female subjects were to be negative for pregnancy

Exclusion criteria

• History of meningococcal disease
• Receipt of any meningococcal vaccine outside of parent study (V59P6)
• Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
• receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
• any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

I: MenACWY-CRM vaccine

Experimental group

Description:

Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study.

Treatment:

Biological: Novartis Meningococcal (MenACWY-CRM) vaccine

II: Licensed Polysaccharide Meningococcal vaccine

Experimental group

Description:

Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study.

Treatment:

Biological: Novartis Meningococcal (MenACWY-CRM) vaccine

III: Meningococcal Naive

Experimental group

Description:

Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study.

Treatment:

Biological: Novartis Meningococcal (MenACWY-CRM) vaccine