Back to resultsEvaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Primary Purpose
Meningococcal Meningitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Children, Persistence, Booster dose
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
- Premier Health Research 9317 Firestone Blvd.
- Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
- Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
- Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
- Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
- Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
- Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
- Children's Memorial Hospital 2300 Children's Plaza, Box 155
- Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
- 28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
- Senders Pediatrics 2054 South Green Road
- Pediatric Medical Associates 160 West Germantown Pike Suite D2
- Children's Health Care 2501 West 12th Street
- Pennridge Pediatric Associates 270 Main Street
- Kid's Way Pediatrics 3068 Innovation Way
- Pediatric Medical Associates 1077 Rydal Road Suite 300
- Pennridge Pediatric Associates 711 Lawn Avenue
- PEAK Research 2859 Washington Rd., Ste. 412B
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Active Comparator
Arm Label
ACWY - 4
ACWY - 2
Naïve - 40
Naïve - 60
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
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 ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
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
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
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.
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 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.
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 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.
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 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 ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-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.
Percentage of Subjects With Seroresponse at 1 Month Post-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 Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
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.
Number of Subjects Reporting Unsolicited AEs and SAEs
Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.
Full Information
NCT ID
NCT01148017
First Posted
June 16, 2010
Last Updated
July 12, 2017
Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01148017
Brief Title
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Official Title
A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Children, Persistence, Booster dose
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
433 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACWY - 4
Arm Type
Experimental
Arm Description
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.
Arm Title
ACWY - 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Naïve - 40
Arm Type
Other
Arm Description
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.
Arm Title
Naïve - 60
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Primary Outcome Measure Information:
Title
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Description
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 ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame
Visit 9 (continuation from the parent study), 40-month visit.
Title
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Description
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.
Time Frame
Visit 10, 60 months of age
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Visit 9, 40 months of age.
Title
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Description
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.
Time Frame
Visit 10, 60 months of age.
Title
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Description
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.
Time Frame
Visit 9 (continuation from the parent study), 40-months of age.
Title
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Description
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.
Time Frame
Visit 10, 60 months of age.
Title
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
Description
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.
Time Frame
Visit 11, 1 month after vaccination.
Title
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Description
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.
Time Frame
Visit 11, 1 month after vaccination.
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Description
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.
Time Frame
From day 1 to 7 after vaccination.
Title
Number of Subjects Reporting Unsolicited AEs and SAEs
Description
Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
37 Months
Maximum Age & Unit of Time
63 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Premier Health Research 9317 Firestone Blvd.
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Children's Memorial Hospital 2300 Children's Plaza, Box 155
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Senders Pediatrics 2054 South Green Road
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Pediatric Medical Associates 160 West Germantown Pike Suite D2
City
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19402
Country
United States
Facility Name
Children's Health Care 2501 West 12th Street
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
Pennridge Pediatric Associates 270 Main Street
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Kid's Way Pediatrics 3068 Innovation Way
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
Pediatric Medical Associates 1077 Rydal Road Suite 300
City
Rydal
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Pennridge Pediatric Associates 711 Lawn Avenue
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
PEAK Research 2859 Washington Rd., Ste. 412B
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31279564
Citation
Klein NP, Block SL, Essink B, Barbi S, Smolenov I, Keshavan P. Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods. Vaccine. 2019 Jul 26;37(32):4460-4467. doi: 10.1016/j.vaccine.2019.06.076. Epub 2019 Jul 3.
Results Reference
derived
Learn more about this trial
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
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