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

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

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease
• Intervention / Treatment: Biological: MenACWY-CRM

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Am Teich 11, Neumuenster, Germany, 24534
    • Dr. Johannes Kandzora and Dr. Kathrin Kandzora
  • Boyneburgstr 7, Eschwege, Germany, 37269
    • Bogda-Maria Kniese,
  • GroBbottwarer Str 47, Oberstenfeld, Germany, 71720
    • Dr Goertz Martin Kimmig
  • Heinrichstrasse 16 A, Fulda, Germany, 36037
    • Dr med Walter Otto
  • Hellersdorfer Str 237, Berlin, Germany, 12627
    • Dr med Kerstin Pscherer
  • Kirchstrasse 2, Bonnigheim, Germany, 74357
    • Dr Renate Mangelsdorf-Taxis
  • Murnauer Str 3, Weilheim, Germany, 82362
    • Dr. Christoph Wittermann
  • Rathausstr 6, Gluecksburg, Germany, 24960
    • Ute Jessat
  • Schoenwalder Str 28, Berlin, Germany, 13347
    • Dr med Luise Schroeter
  • Stuttgarter Strasse 74, Stuttgart Feuerbach, Germany, 70469
    • Dr med Ulrich Pfletschinger
  • Welschgasse 39, Frankenthal, Germany, 67227
    • Dr Lothar Maurer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenACWY (2 primary + 1 booster dose); 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.	Biological: MenACWY-CRM
Experimental: MenACWY (1 primary + 1 booster dose); 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.	Biological: MenACWY-CRM
Experimental: MenC (1 primary dose)+MenACWY (1 booster dose); 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.	Biological: MenACWY-CRM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Children; Meningitis; Persistence; Toddlers; Conjugate Vaccine; Meningococcal; ACWY; Boost
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: V59P22E1