Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

Novartis Vaccines389 enrolled

Overview

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

389

Conditions

Meningococcal Meningitis

Interventions

MenACWY-CRM conjugate vaccineBIOLOGICAL

Licensed comparatorBIOLOGICAL

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Subjects enrolled in V59P13: * healthy subjects who have completed the V59P13 study. Naïve subjects: * healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old). Exclusion Criteria: Subjects who had completed the V59P13 study: * who received any meningococcal vaccine after the V59P13 trial; * who have had previous confirmed or suspected disease caused by N. meningitidis; * who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y); * subjects with any serious, acute or chronic progressive disease. Naïve subjects: * who previously received any meningococcal vaccine; * who have had previous confirmed or suspected disease caused by N. meningitidis; * who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y); * subjects with any serious, acute or chronic progressive disease.

Locations (32)

Outcomes

Primary Outcomes

Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.

Time frame: 21 months, 3 years and 5 years postvaccination

Secondary Outcomes

Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.

Time frame: 21 months, 3 years and 5 years postvaccination

hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.

Time frame: 21 months, 3 years and 5 years postvaccination

Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8

Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Time frame: day 1

hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination

Data from ClinicalTrials.gov

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37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615

Birmingham, Alabama, United States

6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway

Fremont, California, United States

7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor

Fresno, California, United States

8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB

Hayward, California, United States

Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor

Oakland, California, United States

9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies

Roseville, California, United States

11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C

Sacramento, California, United States

Kaiser Permanente, 6600 Bruceville Rd.

Sacramento, California, United States

10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1

San Jose, California, United States

2 PAMPA 2155 Post Oak Tritt Road, Suite 100

Marietta, Georgia, United States

...and 22 more locations

Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.

Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine

Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Time frame: 1 month post booster vaccination

Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine

Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Time frame: 2 years postvaccination

Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine

Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.

Time frame: 2 years postvaccination

Number of Subjects Reporting Solicited Local and Systemic Adverse Events

Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

Time frame: Day 1 to Day 7

Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator

Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.

Time frame: Day 1 to 5 years

Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.

Time frame: 28 days postvaccination