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

NCT ID: NCT01345721

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Meningococcal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

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.

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

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.

Group Type: EXPERIMENTAL

MenACWY-CRM

Intervention Type: BIOLOGICAL

Interventions

MenACWY-CRM

Intervention Type: BIOLOGICAL

Eligibility 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

• 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.

• Minimum Eligible Age: 22 Months
• Maximum Eligible Age: 45 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33325757 (View on PubMed)

Other Identifiers

V59P22E1

Identifier Type: -

Identifier Source: org_study_id