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

Meningococcal Meningitis Clinical Trial

Official title:

An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856297
• Other study ID #: V59P13E1
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2009
• Last updated: December 17, 2013
• Start date: February 2009
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Meningitis

Intervention

Biological:
• MenACWY-CRM conjugate vaccine

• Licensed comparator

Locations

Country	Name	City	State
United States	38 Akron Children's Hospital One Perkins Square	Akron	Ohio
United States	53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102	Bardstown	Kentucky
United States	37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615	Birmingham	Alabama
United States	19 Children's Health Care West 4671 West Lake Road	Erie	Pennsylvania
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	47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H	Galveston	Texas
United States	21 Greenville Medical Centre Inc 90 Shenango Street	Greenville	Pennsylvania
United States	24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue	Grove City	Pennsylvania
United States	8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB	Hayward	California
United States	23 Pediatric Associates of Latrobe 210 Weldon Street	Latrobe	Pennsylvania
United States	2 PAMPA 2155 Post Oak Tritt Road, Suite 100	Marietta	Georgia
United States	Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor	Oakland	California
United States	12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road	Pittsburgh	Pennsylvania
United States	13 Pediatric Alliance Southwestern 850 Clairton Blvd.	Pittsburgh	Pennsylvania
United States	14 Squirrel Hill Office 4070 Beechwood Blvd	Pittsburgh	Pennsylvania
United States	15 South Hills Pediatrics 4411 Stilley Road	Pittsburgh	Pennsylvania
United States	16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100	Pittsburgh	Pennsylvania
United States	20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120	Pittsburgh	Pennsylvania
United States	Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road	Pittsburgh	Pennsylvania
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	56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100	Salt Lake City	Utah
United States	10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1	San Jose	California
United States	45 Group Health Research Institute 1730 Minor Ave, Suite 1600	Seattle	Washington
United States	35 Pennridge Pediatric Associates 711 Lawn Avenue	Sellersville	Pennsylvania
United States	43 Dr. Senders and Associates 2054 South Green Road	South Euclid	Ohio
United States	22 Laurel Pediatrics 140 Wayland Smith Drive	Uniontown	Pennsylvania
United States	25 Family Practice Medical Associates South 2581 Washington Road Suite 211	Upper St. Clair	Pennsylvania
United States	PEAK Research, LLC, 2589 Washington Road, Suite 412B	Upper St. Clair	Pennsylvania
United States	3 PAMPA 120 Stonebridge Parkway Ste. 410	Woodstock	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents. Hum Vaccin. 2010 Nov;6( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 months, 3 years and 5 years postvaccination	No
Secondary	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.	21 months, 3 years and 5 years postvaccination	No
Secondary	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.	21 months, 3 years and 5 years postvaccination	No
Secondary	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.	day 1	No
Secondary	hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination	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.	day 1	No
Secondary	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.	1 month post booster vaccination	No
Secondary	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.	2 years postvaccination	No
Secondary	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.	2 years postvaccination	No
Secondary	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.	Day 1 to Day 7	Yes
Secondary	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.	Day 1 to 5 years	Yes
Secondary	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.	28 days postvaccination	Yes