Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

Meningococcal Disease Clinical Trial

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 or Meningococcal C Conjugate Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345721
• Other study ID #: V59P22E1
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: May 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Months to 45 Months

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• MenACWY-CRM

Locations

Country	Name	City	State
Germany	Dr. Johannes Kandzora and Dr. Kathrin Kandzora	Am Teich 11, Neumuenster
Germany	Bogda-Maria Kniese,	Boyneburgstr 7, Eschwege
Germany	Dr Goertz Martin Kimmig	GroBbottwarer Str 47, Oberstenfeld
Germany	Dr med Walter Otto	Heinrichstrasse 16 A, Fulda
Germany	Dr med Kerstin Pscherer	Hellersdorfer Str 237, Berlin
Germany	Dr Renate Mangelsdorf-Taxis	Kirchstrasse 2, Bonnigheim
Germany	Dr. Christoph Wittermann	Murnauer Str 3, Weilheim
Germany	Ute Jessat	Rathausstr 6, Gluecksburg
Germany	Dr med Luise Schroeter	Schoenwalder Str 28, Berlin
Germany	Dr med Ulrich Pfletschinger	Stuttgarter Strasse 74, Stuttgart Feuerbach
Germany	Dr Lothar Maurer	Welschgasse 39, Frankenthal

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	From 13-33 months post last vaccination in parent study (V59P22)
Primary	Percentage of Subjects With Serum Bactericidal Antibody Titers =1:8, One Month After MenACWY-CRM Booster Vaccination	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.	1 month post booster
Primary	Geometric Mean Titers in Children,One Month After MenACWY-CRM 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.	1 month post booster vaccination
Primary	Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers = 1:8, After One Dose of MenACWY-CRM 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	1 month after vaccination
Primary	Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine	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	1 month post vaccination
Secondary	Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine	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	From 13-33 months post last vaccination in parent study (V59P22)
Secondary	Percentage of Subjects With Serum Bactericidal Titers =1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine	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	1 month post vaccination
Secondary	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	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	1 month post vaccination
Secondary	Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM 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.	Day 1-7 after vaccination
Secondary	Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM 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.	Day 1-28 after vaccination