Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
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
1 other identifier
interventional
389
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2009
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
January 22, 2014
CompletedJune 14, 2017
May 1, 2017
3.8 years
March 2, 2009
October 24, 2013
May 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
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
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
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8
day 1
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination
day 1
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
- +5 more secondary outcomes
Study Arms (5)
MenACWY-CRM
EXPERIMENTALSubjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
Licensed comparator
ACTIVE COMPARATORSubjects 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.
Naive
OTHERSubjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
MenACWY-CRM/MenACWY-CRM
EXPERIMENTALSubjects 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.
Licensed comparator/MenACWY-CRM
EXPERIMENTALSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Vaccineslead
- GlaxoSmithKlinecollaborator
Study Sites (32)
37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
Birmingham, Alabama, 35205, United States
6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
Fremont, California, 94538, United States
7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
Fresno, California, 93726, United States
8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
Hayward, California, 94545, United States
Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
Oakland, California, 94612, United States
9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies
Roseville, California, 95661, United States
11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C
Sacramento, California, 95823, United States
Kaiser Permanente, 6600 Bruceville Rd.
Sacramento, California, 95823, United States
10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
San Jose, California, 95119, United States
2 PAMPA 2155 Post Oak Tritt Road, Suite 100
Marietta, Georgia, 30062, United States
3 PAMPA 120 Stonebridge Parkway Ste. 410
Woodstock, Georgia, 30189, United States
53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102
Bardstown, Kentucky, 40004, United States
38 Akron Children's Hospital One Perkins Square
Akron, Ohio, 44308, United States
43 Dr. Senders and Associates 2054 South Green Road
South Euclid, Ohio, 44121, United States
19 Children's Health Care West 4671 West Lake Road
Erie, Pennsylvania, 16505, United States
21 Greenville Medical Centre Inc 90 Shenango Street
Greenville, Pennsylvania, 16125, United States
24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue
Grove City, Pennsylvania, 16127, United States
23 Pediatric Associates of Latrobe 210 Weldon Street
Latrobe, Pennsylvania, 15650, United States
14 Squirrel Hill Office 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, 15217, United States
16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100
Pittsburgh, Pennsylvania, 15220, United States
15 South Hills Pediatrics 4411 Stilley Road
Pittsburgh, Pennsylvania, 15227, United States
13 Pediatric Alliance Southwestern 850 Clairton Blvd.
Pittsburgh, Pennsylvania, 15236, United States
20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120
Pittsburgh, Pennsylvania, 15237, United States
12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241, United States
Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241, United States
35 Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, 18960, United States
22 Laurel Pediatrics 140 Wayland Smith Drive
Uniontown, Pennsylvania, 15401, United States
25 Family Practice Medical Associates South 2581 Washington Road Suite 211
Upper Saint Clair, Pennsylvania, 15241, United States
PEAK Research, LLC, 2589 Washington Road, Suite 412B
Upper Saint Clair, Pennsylvania, United States
47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H
Galveston, Texas, 77555, United States
56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100
Salt Lake City, Utah, 84121, United States
45 Group Health Research Institute 1730 Minor Ave, Suite 1600
Seattle, Washington, 98101, United States
Related 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(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.
PMID: 21339701RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 5, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
June 14, 2017
Results First Posted
January 22, 2014
Record last verified: 2017-05