Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
- Conditions
- Meningococcal Disease
- Interventions
- Biological: MenACWY-CRM
- Registration Number
- NCT01345721
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
Children eligible to be enrolled in the study were those
- whose parents provide written informed consent;
- were in generally good health based on the clinical judgment of the investigators;
- subjects were 22-45 months of age at the time of enrollment into V59P22E1;
- subject who had participated in the parent V59P22 study.
Main exclusion criteria:
- Subjects with serious, acute, or chronic illnesses
- Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
- Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MenACWY (1 primary + 1 booster dose) MenACWY-CRM Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. MenACWY (2 primary + 1 booster dose) MenACWY-CRM Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. MenC (1 primary dose)+MenACWY (1 booster dose) MenACWY-CRM Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine From 13-33 months post last vaccination in parent study (V59P22) The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported.
The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination 1 month post booster The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination 1 month post booster vaccination The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination 1 month after vaccination The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine 1 month post vaccination The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
- Secondary Outcome Measures
Name Time Method Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine From 13-33 months post last vaccination in parent study (V59P22) The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine 1 month post vaccination Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine 1 month post vaccination Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination Day 1-7 after vaccination The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination Day 1-28 after vaccination The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
Trial Locations
- Locations (11)
Dr. Johannes Kandzora and Dr. Kathrin Kandzora
🇩🇪Am Teich 11, Neumuenster, Germany
Dr Renate Mangelsdorf-Taxis
🇩🇪Kirchstrasse 2, Bonnigheim, Germany
Dr med Kerstin Pscherer
🇩🇪Hellersdorfer Str 237, Berlin, Germany
Bogda-Maria Kniese,
🇩🇪Boyneburgstr 7, Eschwege, Germany
Dr Goertz Martin Kimmig
🇩🇪GroBbottwarer Str 47, Oberstenfeld, Germany
Ute Jessat
🇩🇪Rathausstr 6, Gluecksburg, Germany
Dr. Christoph Wittermann
🇩🇪Murnauer Str 3, Weilheim, Germany
Dr med Luise Schroeter
🇩🇪Schoenwalder Str 28, Berlin, Germany
Dr med Walter Otto
🇩🇪Heinrichstrasse 16 A, Fulda, Germany
Dr med Ulrich Pfletschinger
🇩🇪Stuttgarter Strasse 74, Stuttgart Feuerbach, Germany
Dr Lothar Maurer
🇩🇪Welschgasse 39, Frankenthal, Germany