Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
This study is ongoing, but not recruiting participants.
First Received: January 31, 2008   Last Updated: October 22, 2009   History of Changes
Sponsor: Novartis
Collaborator: Novartis Vaccines
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00616421
  Purpose

This study will evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY conjugate vaccine


Condition Intervention Phase
Meningococcal Infections
Biological: MenACWY
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Subject), Single Group Assignment
Official Title: A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate safety and immune response across groups at pre-defined time points [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To further evaluate safety and immunogencity across groups at pre-defined time points [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 2820
Study Start Date: February 2008
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Experimental
Children 2-5 years of age, 1 dose of MenACWY
Biological: MenACWY
1 dose of MenACWY
3: Active Comparator
Children 2-5 years of age, 1 dose of MenACWY
Biological: MenACWY
1 dose of MenACWY
4: Experimental
Children 6-10 years of age, 1 dose of MenACWY
Biological: MenACWY
1 dose of MenACWY
5: Active Comparator
Children 6-10 years of age, 1 dose of MenACWY
Biological: MenACWY
1 dose of MenACWY
1: Experimental
Children 2-5 years of age, Men ACWY Day 1 and Men ACWY Day 61
Biological: MenACWY
2 doses of MenACWY

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
  • who are available for all visits and telephone calls scheduled for the study
  • who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

  • whose parent or legal guardian is unwilling or unable to give written informed consent
  • who had a previous or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • who have received any investigational agents or vaccines within 90 days prior to enrollment
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
  • who have a history of anaphylaxis, serious vaccine reactions
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
  • who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
  • who have Down's syndrome or other known cytogenic disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616421

  Hide Study Locations
Locations
United States, Arkansas
Children's Investigational Reserach Program
Bentonville, Arkansas, United States, 72712
Arkansas Pediatric Research Group
Little Rock, Arkansas, United States, 72205
United States, California
Premier Health Research Center
Downey, California, United States, 90241
Kaiser Permanente - Oakland
Oakland, California, United States, 94611
Kaiser Permanente - Fresno
Fresno, California, United States, 93726
Kaiser Permanente - Hayward
Hayward, California, United States, 94545
Kaiser Permanente - Fremont
Fremont, California, United States, 94538
Kaiser Permanente - Pleasanton
Pleasanton, California, United States, 94566
Kaiser Permanente - San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente - San Jose
San Jose, California, United States, 95119
United States, Colorado
Kaiser Permanente - Westminister
Westminister, Colorado, United States, 80234
1st Allergy & Clinical Research
Thornton, Colorado, United States, 80233
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
1st Allergy & Clinical Research
Centennial, Colorado, United States, 80112
Kaiser Permanente - Aurora
Aurora, Colorado, United States, 80012
United States, Kentucky
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States, 40004
Physicians to Children & Adolescents
Springfield, Kentucky, United States, 40004
United States, Louisiana
Benchmark Research
Metairie, Louisiana, United States, 70006
United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63104
United States, Nebraska
Meridian Clinical Research LLC
Omaha, Nebraska, United States, 68134
United States, New York
Legacy Pediatrics
Rochester, New York, United States, 14618
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27704
Durham Pediatrics
Durham, North Carolina, United States, 27704
Regional Pediatric Associates PA
Durham, North Carolina, United States, 27704
United States, North Dakota
Odyssey Research
Fargo, North Dakota, United States, 58103
United States, Ohio
Dr. Senders and Associates
Cleveland, Ohio, United States, 44121
United States, Oregon
Calcagno Research & Development
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Children's Community Pediatrics
Wexford, Pennsylvania, United States, 15090
Children's Health Care - West
Erie, Pennsylvania, United States, 16505
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, United States, 15241
Family Healthcare Partners
Grove City, Pennsylvania, United States, 16127
Family Practice Medical Associates South
Upper St. Clair, Pennsylvania, United States, 15241
University Of Pittsburgh Medical Center
Greenville, Pennsylvania, United States, 16125
Laurel Pediatrics
Uniontown, Pennsylvania, United States, 15401
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, United States, 15650
Pediatric Alliance PC
Pittsburgh, Pennsylvania, United States, 15236
Pediatric Alliance PC
Pittsburgh, Pennsylvania, United States, 15217
Pediatric Alliance PC
Pittsburgh, Pennsylvania, United States, 15220
South Hills Pediatrics
Pittsburgh, Pennsylvania, United States, 15227
Primary Physicians Research Inc.
Pittsburg, Pennsylvania, United States, 15237
United States, Tennessee
Jackson Clinic Professional Association
Jackson, Tennessee, United States, 38305
United States, Texas
Benchmark Research San Angelo
San Angelo, Texas, United States, 76904
Benchmark Research Ft. Worth
Fort Worth, Texas, United States, 76135
United States, Utah
J. Lewis Research Inc.
Salt Lake City, Utah, United States, 84121
J. Lewis Research Inc.
Salt Lake City, Utah, United States, 84109
Copperview Medical Center
South Jordan, Utah, United States, 84095
Wee Care Pediatrics
Layton, Utah, United States, 84041
Cottonwood Pediatrics
Murray, Utah, United States, 84107
Jean Brown Research
Clinton, Utah, United States, 84015
Jean Brown Research
Salt Lake City, Utah, United States, 84124
United States, Washington
Rockwood Clinic
Spokane, Washington, United States, 99202
Rockwood Clinic North
Spokane, Washington, United States, 99218
Canada, British Columbia
TASC Research Services Inc.
Surrey, British Columbia, Canada, V3R 8P8
Canada, Manitoba
Manitoba Clinic
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Nova Scotia
Clinical Trials Research Center
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Herridge Community Health Clinic
Ottawa, Ontario, Canada, K1S 0G8
Albion Finch Medical Centre
Etobicoke, Ontario, Canada, M9V 4B4
SKDS Research In.
Newmarket, Ontario, Canada, L3Y 5G8
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada, N7T 4X3
Canada, Prince Edward Island
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis Vaccines ( Novartis )
Study ID Numbers: V59P20, 11278
Study First Received: January 31, 2008
Last Updated: October 22, 2009
ClinicalTrials.gov Identifier: NCT00616421     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Novartis:
vaccine
children
healthy
meningitis
meningococcal
Prevention of Meningococcal disease serogroups ACWY

Additional relevant MeSH terms:
Bacterial Infections
Meningococcal Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 27, 2009