Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
- Conditions
- Meningococcal Meningitis
- Interventions
- Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
- Registration Number
- NCT01148017
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 433
- Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
- Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
- Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.
- Serious, acute, or chronic illnesses are reasons for exclusion.
- Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
- Subjects who have received any meningococcal vaccine since birth (Groups 3 & 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 & 2 - follow on).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACWY - 2 Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine Subjects who had previously received 1 or 2 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age. Naïve - 60 Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. ACWY - 4 Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine Subjects who had previously received 4 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their first year of life are administered one booster dose of the same vaccine at 60 months of age. Naïve - 40 Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
- Primary Outcome Measures
Name Time Method Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y Visit 10, 60 months of age The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
- Secondary Outcome Measures
Name Time Method Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age Visit 10, 60 months of age. The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination Visit 11, 1 month after vaccination. The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.
Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4.Number of Subjects Reporting Unsolicited AEs and SAEs Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups). Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age Visit 10, 60 months of age. The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age Visit 9, 40 months of age. The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age Visit 9 (continuation from the parent study), 40-months of age. The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination Visit 11, 1 month after vaccination. The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From day 1 to 7 after vaccination. Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.
Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs.
Trial Locations
- Locations (19)
Premier Health Research 9317 Firestone Blvd.
🇺🇸Downey, California, United States
Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
🇺🇸Oakland, California, United States
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
🇺🇸Paramount, California, United States
Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
🇺🇸Paramount, California, United States
Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
🇺🇸Pleasanton, California, United States
Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
🇺🇸San Francisco, California, United States
Children's Memorial Hospital 2300 Children's Plaza, Box 155
🇺🇸Chicago, Illinois, United States
Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
🇺🇸Santa Clara, California, United States
Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
🇺🇸Bardstown, Kentucky, United States
Senders Pediatrics 2054 South Green Road
🇺🇸Cleveland, Ohio, United States
Pediatric Medical Associates 160 West Germantown Pike Suite D2
🇺🇸East Norriton, Pennsylvania, United States
Children's Health Care 2501 West 12th Street
🇺🇸Erie, Pennsylvania, United States
Pennridge Pediatric Associates 270 Main Street
🇺🇸Harleysville, Pennsylvania, United States
Kid's Way Pediatrics 3068 Innovation Way
🇺🇸Hermitage, Pennsylvania, United States
Pennridge Pediatric Associates 711 Lawn Avenue
🇺🇸Sellersville, Pennsylvania, United States
PEAK Research 2859 Washington Rd., Ste. 412B
🇺🇸Upper Saint Clair, Pennsylvania, United States
Pediatric Medical Associates 1077 Rydal Road Suite 300
🇺🇸Rydal, Pennsylvania, United States
28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
🇺🇸Annapolis, Maryland, United States