Clinical trial NCT01345721: Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Toddlers
Children
Persistence
Boost
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 205
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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:

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.

Primary outcomes:
measure: 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
timeFrame: From 13-33 months post last vaccination in parent study (V59P22)
measure: Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
timeFrame: 1 month post booster
measure: Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
timeFrame: 1 month post booster vaccination
measure: Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
timeFrame: 1 month after vaccination
measure: Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
timeFrame: 1 month post vaccination
Secondary outcomes:
measure: Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
timeFrame: From 13-33 months post last vaccination in parent study (V59P22)
measure: Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
timeFrame: 1 month post vaccination
measure: 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
timeFrame: 1 month post vaccination
measure: Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
timeFrame: Day 1-7 after vaccination
measure: Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
timeFrame: Day 1-28 after vaccination
Other outcomes:
Locations:
city: Am Teich 11, Neumuenster
country: Germany
facility: Dr. Johannes Kandzora and Dr. Kathrin Kandzora
city: Boyneburgstr 7, Eschwege
country: Germany
facility: Bogda-Maria Kniese,
city: GroBbottwarer Str 47, Oberstenfeld
country: Germany
facility: Dr Goertz Martin Kimmig
city: Heinrichstrasse 16 A, Fulda
country: Germany
facility: Dr med Walter Otto
city: Hellersdorfer Str 237, Berlin
country: Germany
facility: Dr med Kerstin Pscherer
city: Kirchstrasse 2, Bonnigheim
country: Germany
facility: Dr Renate Mangelsdorf-Taxis
city: Murnauer Str 3, Weilheim
country: Germany
facility: Dr. Christoph Wittermann
city: Rathausstr 6, Gluecksburg
country: Germany
facility: Ute Jessat
city: Schoenwalder Str 28, Berlin
country: Germany
facility: Dr med Luise Schroeter
city: Stuttgarter Strasse 74, Stuttgart Feuerbach
country: Germany
facility: Dr med Ulrich Pfletschinger
city: Welschgasse 39, Frankenthal
country: Germany
facility: Dr Lothar Maurer
Study officials:
References:
citation: 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.