Clinical trial NCT00856297: Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Keywords: Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Adolescents
Persistence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-03-05
Enrollment: 389
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 21 months, 3 years and 5 years postvaccination
Secondary outcomes:
measure: Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
timeFrame: 21 months, 3 years and 5 years postvaccination
measure: hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
timeFrame: 21 months, 3 years and 5 years postvaccination
measure: Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8
timeFrame: day 1
measure: hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination
timeFrame: day 1
measure: Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine
timeFrame: 1 month post booster vaccination
measure: Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine
timeFrame: 2 years postvaccination
measure: Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine
timeFrame: 2 years postvaccination
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events
timeFrame: Day 1 to Day 7
measure: Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator
timeFrame: Day 1 to 5 years
measure: Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
timeFrame: 28 days postvaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
state: Alabama
city: Fremont
country: United States
facility: 6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
state: California
city: Fresno
country: United States
facility: 7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
state: California
city: Hayward
country: United States
facility: 8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
state: California
city: Oakland
country: United States
facility: Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
state: California
city: Roseville
country: United States
facility: 9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies
state: California
city: Sacramento
country: United States
facility: 11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente, 6600 Bruceville Rd.
state: California
city: San Jose
country: United States
facility: 10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
state: California
city: Marietta
country: United States
facility: 2 PAMPA 2155 Post Oak Tritt Road, Suite 100
state: Georgia
city: Woodstock
country: United States
facility: 3 PAMPA 120 Stonebridge Parkway Ste. 410
state: Georgia
city: Bardstown
country: United States
facility: 53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102
state: Kentucky
city: Akron
country: United States
facility: 38 Akron Children's Hospital One Perkins Square
state: Ohio
city: South Euclid
country: United States
facility: 43 Dr. Senders and Associates 2054 South Green Road
state: Ohio
city: Erie
country: United States
facility: 19 Children's Health Care West 4671 West Lake Road
state: Pennsylvania
city: Greenville
country: United States
facility: 21 Greenville Medical Centre Inc 90 Shenango Street
state: Pennsylvania
city: Grove City
country: United States
facility: 24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue
state: Pennsylvania
city: Latrobe
country: United States
facility: 23 Pediatric Associates of Latrobe 210 Weldon Street
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 14 Squirrel Hill Office 4070 Beechwood Blvd
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 15 South Hills Pediatrics 4411 Stilley Road
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 13 Pediatric Alliance Southwestern 850 Clairton Blvd.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road
state: Pennsylvania
city: Sellersville
country: United States
facility: 35 Pennridge Pediatric Associates 711 Lawn Avenue
state: Pennsylvania
city: Uniontown
country: United States
facility: 22 Laurel Pediatrics 140 Wayland Smith Drive
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: 25 Family Practice Medical Associates South 2581 Washington Road Suite 211
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research, LLC, 2589 Washington Road, Suite 412B
state: Pennsylvania
city: Galveston
country: United States
facility: 47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H
state: Texas
city: Salt Lake City
country: United States
facility: 56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100
state: Utah
city: Seattle
country: United States
facility: 45 Group Health Research Institute 1730 Minor Ave, Suite 1600
state: Washington
Study officials:
affiliation: Novartis
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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(R)) or Menactra(R) among healthy adolescents. Hum Vaccin. 2010 Nov;6(11):881-7. doi: 10.4161/hv.6.11.12849. Epub 2010 Nov 1.