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

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 N. 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: Meningococcal ACWY	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:

MedlinePlus related topics: Meningococcal Infections

Drug Information available for: Lactitol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

At all time points, in all subjects the following will be evaluated: [ Time Frame: 22-45 months of age and 1 month post Novartis MenACWY vaccination in V59P22E1 trial ] [ Designated as safety issue: No ]
1. Percentage of subject with hSBA titers ≥ 1:8
2. hSBA geometric mean titers (GMTs), N. meningitidis serogroups A, C, W-135 and Y The persistence is defined as a function of time, from the last vaccination, of the serogroup specific hSBA titers.

Secondary Outcome Measures:

Safety Endpoints [ Time Frame: For 28 days post Novartis MenACWY vaccination in V59P22E1 trial ] [ Designated as safety issue: No ]
- The percentage of subjects with solicited local and systemic reactions within 7 days after vaccination with MenACWY.
- The percentage of subjects with unsolicited AEs within 7 days (day 1-7) after vaccination with MenACWY and SAEs and AEs necessitating a medica attendance and/or resulting in premature withdrawal from Visit 7 to Visit 8.

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: Arm 1	Biological: Meningococcal ACWY For each arm, a blood draw followed by Novartis MenACWY injection will be requested in the first visit of this trial. 1 month later an additional blood draw will be requested.
Experimental: Arm 2	Biological: Meningococcal ACWY For each arm, a blood draw followed by Novartis MenACWY injection will be requested in the first visit of this trial. 1 month later an additional blood draw will be requested.
Experimental: Arm 3	Biological: Meningococcal ACWY For each arm, a blood draw followed by Novartis MenACWY injection will be requested in the first visit of this trial. 1 month later an additional blood draw will be requested.

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 are those

whose parents provide written informed consent;
are in generally good health based on the clinical judgment of the investigators.
Subjects must be 22-45 months of age at the time of enrollment into V59P22E1
subject participated in the original V59P22 study.

Exclusion Criteria:

Main exclusion criteria:

Subjects with serious, acute, or chronic illnesses
Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines are excluded for the 14 days prior to the enrollment visit.
Subjects who have received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.

Contacts and Locations

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

Locations

Germany
Praxis Dr GoertzMartinKimmig
Oberstenfeld, Grossbottwarer Str 47, Germany, 71720
Praxis Dr med Walter OttoWalterOtto
Fulda, Heinrichstrasse 16a, Germany, 36037
Praxis Dr Kerstin PschererKerstinPscherer
Berlin, Hellersdorfer Str 237, Germany, 12627
Praxis Dr Renate MangelsdorfTaxisRenateMangelsdorfTaxis
Boennigheim, Kirchstrasse 2, Germany, 74357
Praxis Dr Christoph WittermannChristophWittermann
Weilheim, Muenchner Str 35, Germany, 82362
Praxis Ute JessatUteJessat
Gluecksburg, Rathausstr 6, Germany, 24960
Praxis Dr Luise SchroeterLuiseSchroeter
Berlin, Schoenwalder Str 28, Germany, 13347
Praxis Dr Ulrich PfletschingerUlrichPfletschinger
Stuttgart Feuerbach, Stuttgarter Strasse 74, Germany, 70469
Praxis Dr Lothar MaurerJunLotharMaurerJun
Frankenthal, Welschgasse 39, Germany, 67227
Praxis BogdaMaria Kniese,Boyneburger Str 7
Eschwege, Germany, 37269
Praxis Drs J und K KandzoraJohannesKandzora, Am Teich 11
Neumuenster, Germany, 24534

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
Last Updated:	February 24, 2012
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 May 23, 2013