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

NCT01345721 | Completed Phase 3 Results

• 1 other identifier: V59P22E1
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 11

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

Keywords

Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Toddlers; Children; Persistence; Boost

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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)

• 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

• 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

• Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination

  Day 1-7 after vaccination

• Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination

  Day 1-28 after vaccination

Study Arms (3)

MenACWY (2 primary + 1 booster dose)

EXPERIMENTAL

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

MenACWY (1 primary + 1 booster dose)

EXPERIMENTAL

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

MenC (1 primary dose)+MenACWY (1 booster dose)

EXPERIMENTAL

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

Interventions

MenACWY-CRM BIOLOGICAL

MenACWY (1 primary + 1 booster dose); MenACWY (2 primary + 1 booster dose); MenC (1 primary dose)+MenACWY (1 booster dose)

Eligibility Criteria

• Age: 22 Months - 45 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (11)

Dr. Johannes Kandzora and Dr. Kathrin Kandzora

Am Teich 11, Neumuenster, 24534, Germany

Location

Bogda-Maria Kniese,

Boyneburgstr 7, Eschwege, 37269, Germany

Location

Dr Goertz Martin Kimmig

GroBbottwarer Str 47, Oberstenfeld, 71720, Germany

Location

Dr med Walter Otto

Heinrichstrasse 16 A, Fulda, 36037, Germany

Location

Dr med Kerstin Pscherer

Hellersdorfer Str 237, Berlin, 12627, Germany

Location

Dr Renate Mangelsdorf-Taxis

Kirchstrasse 2, Bonnigheim, 74357, Germany

Location

Dr. Christoph Wittermann

Murnauer Str 3, Weilheim, 82362, Germany

Location

Ute Jessat

Rathausstr 6, Gluecksburg, 24960, Germany

Location

Dr med Luise Schroeter

Schoenwalder Str 28, Berlin, 13347, Germany

Location

Dr med Ulrich Pfletschinger

Stuttgarter Strasse 74, Stuttgart Feuerbach, 70469, Germany

Location

Dr Lothar Maurer

Welschgasse 39, Frankenthal, 67227, Germany

Location

Related Publications (1)

• 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.

  PMID: 33325757 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Interventions

MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 18, 2018
• Results First Posted: October 18, 2013

Record last verified: 2018-05

Locations

DE (11)