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

Phase 3

Completed

Conditions: Meningococcal Meningitis

Registration Number: NCT00856297

Lead Sponsor: Novartis Vaccines

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 389

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	21 months, 3 years and 5 years postvaccination	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.

Secondary Outcome Measures

Name	Time	Method
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination	day 1	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	1 month post booster vaccination	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.
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator	Day 1 to 5 years	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.
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine	28 days postvaccination	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.
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine	21 months, 3 years and 5 years postvaccination	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.
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8	day 1	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.
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine	2 years postvaccination	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.
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine	2 years postvaccination	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.
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine	21 months, 3 years and 5 years postvaccination	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.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events	Day 1 to Day 7	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.

Trial Locations

Locations (32): 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
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Birmingham, Alabama, United States
6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
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Fremont, California, United States
7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
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Fresno, California, United States
8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
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Hayward, California, United States
Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
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Oakland, California, United States
9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies
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Roseville, California, United States
11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C
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Sacramento, California, United States
Kaiser Permanente, 6600 Bruceville Rd.
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Sacramento, California, United States
10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
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San Jose, California, United States
2 PAMPA 2155 Post Oak Tritt Road, Suite 100
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Marietta, Georgia, United States
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37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
🇺🇸Birmingham, Alabama, United States