Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
NCT ID: NCT01682876
Last Updated: 2019-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
715 participants
INTERVENTIONAL
2012-10-07
2014-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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2 through 5 years (1 Vac) MenACWY-CRM 1
Subjects 2 through 5 years received one vaccination of MenACWY-CRM
MenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
2 through 5 years (2 Vac) MenACWY-CRM 2
Subjects 2 through 5 years received two vaccinations of MenACWY-CRM
MenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
6 through 10 years (1 Vac) MenACWY-CRM 3
Subjects 6 through 10 years received one vaccination of MenACWY-CRM
MenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
6 through 10 years (2 Vac) MenACWY-CRM 4
Subjects 6 through 10 years received two vaccinations of MenACWY-CRM
MenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
Interventions
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MenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Perceived to be unreliable or unavailable for the duration of the study period.
3. Previous confirmed or suspected disease caused by N. meningitidis.
4. Previously immunized with a meningococcal vaccine (licensed or investigational).
5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.
(certain exceptions influenza vaccines apply)
7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
* receipt of immunosuppressive therapy,
* receipt of immunostimulants,
* receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
2 Years
10 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Lake Mary, Florida, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Woodstock, Georgia, United States
GSK Investigational Site
Council Bluffs, Iowa, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Niles, Michigan, United States
GSK Investigational Site
Stevensville, Michigan, United States
GSK Investigational Site
Bellevue, Nebraska, United States
GSK Investigational Site
Fremont, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Johnson City, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
West Jordan, Utah, United States
Countries
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References
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Johnston W, Essink B, Kirstein J, Forleo-Neto E, Percell S, Han L, Keshavan P, Smolenov I. Comparative Assessment of a Single Dose and a 2-dose Vaccination Series of a Quadrivalent Meningococcal CRM-conjugate Vaccine (MenACWY-CRM) in Children 2-10 Years of Age. Pediatr Infect Dis J. 2016 Jan;35(1):e19-27. doi: 10.1097/INF.0000000000000931.
Other Identifiers
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V59_57
Identifier Type: OTHER
Identifier Source: secondary_id
2011-004421-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
205238
Identifier Type: -
Identifier Source: org_study_id
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