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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
| 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 |
|
vaccine children healthy |
meningitis meningococcal Prevention of Meningococcal disease serogroups ACWY |
|
Bacterial Infections Meningococcal Infections Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |