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

Novartis Vaccines155 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

155

Conditions

Meningococcal Disease Meningococcal Meningitis

Interventions

Novartis Meningococcal (MenACWY-CRM) vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 16 YearsMax age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Rochester, Minnesota, United States

Unnamed facility

Pittsburgh, Pennsylvania, United States

Unnamed facility

Seattle, Washington, United States

Outcomes

Primary Outcomes

Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination

Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

Time frame: Day 1 (5 years after primary vaccination)

Geometric Mean Titer After Booster Vaccination

Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

Time frame: Day 8, Day 29 (5 years after primary vaccination)

Secondary Outcomes

Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination

Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

Time frame: Day 1 (5 years after primary vaccination )

Geometric Mean Titer at 5 Years After Primary Vaccination

Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

Time frame: Day 1 (5 years after primary vaccination )

Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination

Data from ClinicalTrials.gov

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