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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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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MenACWY-CRM

Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.

Group Type EXPERIMENTAL

MenACWY-CRM conjugate vaccine

Intervention Type BIOLOGICAL

Licensed comparator

Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.

Group Type ACTIVE_COMPARATOR

Licensed comparator

Intervention Type BIOLOGICAL

Naive

Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.

Group Type OTHER

MenACWY-CRM conjugate vaccine

Intervention Type BIOLOGICAL

Licensed comparator

Intervention Type BIOLOGICAL

MenACWY-CRM/MenACWY-CRM

Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

Group Type EXPERIMENTAL

MenACWY-CRM conjugate vaccine

Intervention Type BIOLOGICAL

Licensed comparator/MenACWY-CRM

Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

Group Type EXPERIMENTAL

MenACWY-CRM conjugate vaccine

Intervention Type BIOLOGICAL

Licensed comparator

Intervention Type BIOLOGICAL

Interventions

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MenACWY-CRM conjugate vaccine

Intervention Type BIOLOGICAL

Licensed comparator

Intervention Type BIOLOGICAL

Other Intervention Names

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Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier

Eligibility Criteria

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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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis

Locations

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

Birmingham, Alabama, United States

Site Status

6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway

Fremont, California, United States

Site Status

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

Fresno, California, United States

Site Status

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

Hayward, California, United States

Site Status

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

Oakland, California, United States

Site Status

9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies

Roseville, California, United States

Site Status

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

Sacramento, California, United States

Site Status

Kaiser Permanente, 6600 Bruceville Rd.

Sacramento, California, United States

Site Status

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

San Jose, California, United States

Site Status

2 PAMPA 2155 Post Oak Tritt Road, Suite 100

Marietta, Georgia, United States

Site Status

3 PAMPA 120 Stonebridge Parkway Ste. 410

Woodstock, Georgia, United States

Site Status

53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102

Bardstown, Kentucky, United States

Site Status

38 Akron Children's Hospital One Perkins Square

Akron, Ohio, United States

Site Status

43 Dr. Senders and Associates 2054 South Green Road

South Euclid, Ohio, United States

Site Status

19 Children's Health Care West 4671 West Lake Road

Erie, Pennsylvania, United States

Site Status

21 Greenville Medical Centre Inc 90 Shenango Street

Greenville, Pennsylvania, United States

Site Status

24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue

Grove City, Pennsylvania, United States

Site Status