Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
- Conditions
- Meningococcal Meningitis
- Interventions
- Biological: MenACWY-CRM conjugate vaccineBiological: Licensed comparator
- 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
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).
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
- Arm && Interventions
Group Intervention Description Naive MenACWY-CRM conjugate vaccine Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. MenACWY-CRM MenACWY-CRM conjugate vaccine Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study. Licensed comparator 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. Naive Licensed comparator Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations. MenACWY-CRM/MenACWY-CRM MenACWY-CRM conjugate vaccine 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. Licensed comparator/MenACWY-CRM MenACWY-CRM conjugate vaccine 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. Licensed comparator/MenACWY-CRM Licensed comparator 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.
- 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)
23 Pediatric Associates of Latrobe 210 Weldon Street
🇺🇸Latrobe, Pennsylvania, United States
PEAK Research, LLC, 2589 Washington Road, Suite 412B
🇺🇸Upper Saint Clair, Pennsylvania, United States
8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
🇺🇸Hayward, California, United States
Kaiser Permanente, 6600 Bruceville Rd.
🇺🇸Sacramento, California, United States
24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue
🇺🇸Grove City, Pennsylvania, United States
43 Dr. Senders and Associates 2054 South Green Road
🇺🇸South Euclid, Ohio, United States
19 Children's Health Care West 4671 West Lake Road
🇺🇸Erie, Pennsylvania, United States
22 Laurel Pediatrics 140 Wayland Smith Drive
🇺🇸Uniontown, Pennsylvania, United States
2 PAMPA 2155 Post Oak Tritt Road, Suite 100
🇺🇸Marietta, Georgia, United States
53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102
🇺🇸Bardstown, Kentucky, United States
16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100
🇺🇸Pittsburgh, Pennsylvania, United States
38 Akron Children's Hospital One Perkins Square
🇺🇸Akron, Ohio, United States
15 South Hills Pediatrics 4411 Stilley Road
🇺🇸Pittsburgh, Pennsylvania, United States
20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120
🇺🇸Pittsburgh, Pennsylvania, United States
12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road
🇺🇸Pittsburgh, Pennsylvania, United States
Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road
🇺🇸Pittsburgh, Pennsylvania, United States
47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H
🇺🇸Galveston, Texas, United States
56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100
🇺🇸Salt Lake City, Utah, United States
7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
🇺🇸Fresno, California, 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
10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
🇺🇸San Jose, California, United States
13 Pediatric Alliance Southwestern 850 Clairton Blvd.
🇺🇸Pittsburgh, Pennsylvania, United States
21 Greenville Medical Centre Inc 90 Shenango Street
🇺🇸Greenville, Pennsylvania, United States
14 Squirrel Hill Office 4070 Beechwood Blvd
🇺🇸Pittsburgh, Pennsylvania, United States
25 Family Practice Medical Associates South 2581 Washington Road Suite 211
🇺🇸Upper Saint Clair, Pennsylvania, 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
37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
🇺🇸Birmingham, Alabama, United States
Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
🇺🇸Oakland, California, United States
3 PAMPA 120 Stonebridge Parkway Ste. 410
🇺🇸Woodstock, Georgia, United States
6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
🇺🇸Fremont, California, United States