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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Meningococcal Disease Meningococcal Meningitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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I: MenACWY-CRM vaccine

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.

Group Type EXPERIMENTAL

Novartis Meningococcal (MenACWY-CRM) vaccine

Intervention Type BIOLOGICAL

All subjects will have blood draws at Day 1, Day 8, and Day 29.

II: Licensed Polysaccharide Meningococcal vaccine

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.

Group Type EXPERIMENTAL

Novartis Meningococcal (MenACWY-CRM) vaccine

Intervention Type BIOLOGICAL

All subjects will have blood draws at Day 1, Day 8, and Day 29.

III: Meningococcal Naive

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.

Group Type EXPERIMENTAL

Novartis Meningococcal (MenACWY-CRM) vaccine

Intervention Type BIOLOGICAL

All subjects will have blood draws at Day 1, Day 8, and Day 29.

Interventions

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Novartis Meningococcal (MenACWY-CRM) vaccine

All subjects will have blood draws at Day 1, Day 8, and Day 29.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes