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| Sponsors and Collaborators: |
Novartis 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 |
| Estimated Enrollment: | 1418 |
| 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
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3: Active Comparator
Children 2-5 years of age, 1 dose of MenACWY
|
Biological: MenACWY
1 dose of MenACWY
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4: Experimental
Children 6-10 years of age, 1 dose of MenACWY
|
Biological: MenACWY
1 dose of MenACWY
|
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5: Active Comparator
Children 6-10 years of age, 1 dose of MenACWY
|
Biological: MenACWY
1 dose of MenACWY
|
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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| Contact: Novartis Drug Information Services | +1 800 244 7668 |
| Canada, British Columbia | |||||
| TASC Research Services Inc. | Recruiting | ||||
| Surrey, British Columbia, Canada, V3R 8P8 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Canada, Manitoba | |||||
| Manitoba Clinic | Recruiting | ||||
| Winnipeg, Manitoba, Canada, R3A 1M3 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Canada, Nova Scotia | |||||
| Clinical Trials Research Center | Recruiting | ||||
| Halifax, Nova Scotia, Canada, B3K 6R8 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Canada, Ontario | |||||
| Herridge Community Health Clinic | Recruiting | ||||
| Ottawa, Ontario, Canada, K1S 0G8 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Albion Finch Medical Centre | Recruiting | ||||
| Etobicoke, Ontario, Canada, M9V 4B4 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| SKDS Research In. | Recruiting | ||||
| Newmarket, Ontario, Canada, L3Y 5G8 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Sarnia Institute of Clinical Research | Recruiting | ||||
| Sarnia, Ontario, Canada, N7T 4X3 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Canada, Prince Edward Island | |||||
| Queen Elizabeth Hospital | Recruiting | ||||
| Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Canada, Saskatchewan | |||||
| Royal University Hospital | Recruiting | ||||
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |||||
| Principal Investigator: Novartis Vaccines | |||||
| Novartis |
| Novartis Vaccines |
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
| Responsible Party: | Novartis Vaccines ( Novartis ) |
| Study ID Numbers: | V59P20, 11278 |
| First Received: | January 31, 2008 |
| Last Updated: | April 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00616421 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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