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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01345721
First received: April 29, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 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.


Condition Intervention Phase
Meningococcal Disease
Biological: MenACWY-CRM
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 [ Time Frame: 13-33 months post primary vaccination ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 month post booster ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post booster vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination ] [ Designated as safety issue: No ]
    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:
  • Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine [ Time Frame: 13-33 months after primary vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1-7 after vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1-28 after vaccination ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 205
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   22 Months to 45 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345721

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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01345721     History of Changes
Other Study ID Numbers: V59P22E1
Study First Received: April 29, 2011
Results First Received: August 13, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Toddlers
Children
Persistence
Boost

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014