Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine - Full Text View

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00856297

Purpose

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercial available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Condition	Intervention	Phase
Meningococcal Meningitis	Other: Group I Other: Group II Other: Group III Other: Group IV Other: Group V	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	An Open-Label, Multi-Center Study to Evaluate the Persistence Of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercial Available MenACWY Conjugate Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

21 months, 3, 5 and 7 years persistence of bactericidal antibodies antibody response [ Time Frame: 21 months, 3, 5 and 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1050
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1	Other: Group I Subjects who previously received the Novartis MenACWY vaccine. Blood draw at 21 months, 3, 5 and 7 years after study vaccine in V59P13
No Intervention: 2	Other: Group II Subjects who previously received Commercial available MenACWY. Blood draw at 21 months, 3, 5 and 7 years after study vaccine in V59P13.
No Intervention: 3	Other: Group III Subjects, age-matched with Group I and Group II, who will be enrolled at each of the four study visits.
Experimental: 4	Other: Group IV Subjects who previously received Novartis MenACWY vaccine. Blood draw at 3 years post injection in V59P13 trial, followed by Novartis MenACWY booster dose. Blood draw 1 month post boost and at 5 and 7 years post injection in V59P13 trial.
Experimental: 5	Other: Group V Subjects who previously received Commercial available MenACWY vaccine. Blood draw at 3 years post injection in V59P13 trial, followed by Novartis MenACWY booster dose. Blood draw 1 month post boost and at 5 and 7 years post injection in V59P13 trial.

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects enrolled in V59P13
Healthy, who have completed the V59P13 study and are in good health;
Naïve subjects
Healthy children aged-matched with subjects enrolled in V59P13 trial.

Exclusion Criteria:

Subjects enrolled in V59P13:

who received any meningococcal vaccine after V59P13 trial;
who have had a previous confirmed or suspected disease caused by N. meningitidis;
who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
Subjects with any serious, acute or chronic progressive disease. Naïve subjects
who previously received any meningococcal vaccine;
who have had a previous confirmed or suspected disease caused by N. meningitidis;
who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
Subjects with any serious, acute or chronic progressive disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856297

Contacts

Contact: Novartis Drug Information Services

+1 800 244 7668

Locations

United States, Alabama
Birmingham Pediatric Associates	Recruiting
Birmingham, Alabama, United States, 35205
United States, California
Kaiser Permanente Vaccine Study Center	Recruiting
Oakland, California, United States, 94612
United States, Georgia
PAMPA	Recruiting
Marietta, Georgia, United States, 30062
United States, Kentucky
Pediatric/Adult Research Inc.	Recruiting
Bardstown, Kentucky, United States, 40004
United States, Ohio
Akron Children's Hospital	Recruiting
Akron, Ohio, United States, 44308
Dr. Senders and Associates	Recruiting
South Euclid, Ohio, United States, 44121
United States, Pennsylvania
Primary Physicians Research, Inc.	Recruiting
Pittsburgh, Pennsylvania, United States, 15241
Pennridge Pediatric Associates	Recruiting
Sellersville, Pennsylvania, United States, 18960
United States, Texas
UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital	Recruiting
Galveston, Texas, United States, 77555
United States, Utah
J. Lewis Research, Inc/Foothill Family Clinic South	Recruiting
Salt Lake City, Utah, United States, 84109

Sponsors and Collaborators

Novartis

Novartis Vaccines

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents. Hum Vaccin. 2010 Nov 1;6(11):881-7. Epub 2010 Nov 1.

Responsible Party:	Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier:	NCT00856297 History of Changes
Other Study ID Numbers:	V59P13E1
Study First Received:	March 2, 2009
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Meningococcal
ACWY
Conjugate Vaccine

Meningitis
Adolescents
Persistence

Additional relevant MeSH terms:

Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial

Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012