Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
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
2 other identifiers
interventional
2,907
2 countries
68
Brief Summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2008
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
June 9, 2011
CompletedFebruary 15, 2016
January 1, 2016
1.1 years
January 31, 2008
February 28, 2011
January 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
1 month postvaccination
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
1 month postvaccination
Secondary Outcomes (11)
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
1 month postvaccination
- +6 more secondary outcomes
Study Arms (3)
MenACWY-CRM (1 dose)
EXPERIMENTAL1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.
Licensed polysaccharide vaccine
ACTIVE COMPARATOR1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1
MenACWY-CRM (2 doses)
EXPERIMENTAL2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.
Interventions
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
1 injection of the licensed meningococcal ACWY was administered intramuscularly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Children's Investigational Reserach Program
Bentonville, Arkansas, 72712, United States
Arkansas Pediatric Research Group
Little Rock, Arkansas, 72205, United States
Premier Health Research Center
Downey, California, 90241, United States
Kaiser Permanente - Fremont
Fremont, California, 94538, United States
Kaiser Permanente - Fresno
Fresno, California, 93726, United States
Kaiser Permanente - Hayward
Hayward, California, 94545, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
Kaiser Permanente - Pleasanton
Pleasanton, California, 94566, United States
Kaiser Permanente - San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente - San Jose
San Jose, California, 95119, United States
Kaiser Permanente - Aurora
Aurora, Colorado, 80012, United States
1st Allergy & Clinical Research
Centennial, Colorado, 80112, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
1st Allergy & Clinical Research
Thornton, Colorado, 80233, United States
Kaiser Permanente - Westminister
Westminister, Colorado, 80234, United States
Kentucky Pediatric Research Center
Bardstown, Kentucky, 40004, United States
Physicians to Children & Adolescents
Springfield, Kentucky, 40004, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
St. Louis University School of Medicine
St Louis, Missouri, 63104, United States
Meridian Clinical Research LLC
Omaha, Nebraska, 68134, United States
Legacy Pediatrics
Rochester, New York, 14618, United States
Duke University Medical Center
Durham, North Carolina, 27704, United States
Durham Pediatrics
Durham, North Carolina, 27704, United States
Regional Pediatric Associates PA
Durham, North Carolina, 27704, United States
Odyssey Research
Fargo, North Dakota, 58103, United States
Dr. Senders and Associates
Cleveland, Ohio, 44121, United States
Calcagno Research & Development
Gresham, Oregon, 97030, United States
Children's Health Care - West
Erie, Pennsylvania, 16505, United States
University Of Pittsburgh Medical Center
Greenville, Pennsylvania, 16125, United States
Family Healthcare Partners
Grove City, Pennsylvania, 16127, United States
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, 15650, United States
Pediatric Alliance PC
Pittsburgh, Pennsylvania, 15217, United States
Pediatric Alliance PC
Pittsburgh, Pennsylvania, 15220, United States
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227, United States
Pediatric Alliance PC
Pittsburgh, Pennsylvania, 15236, United States
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15237, United States
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15241, United States
Laurel Pediatrics
Uniontown, Pennsylvania, 15401, United States
Family Practice Medical Associates South
Upper Saint Clair, Pennsylvania, 15241, United States
Children's Community Pediatrics
Wexford, Pennsylvania, 15090, United States
Jackson Clinic Professional Association
Jackson, Tennessee, 38305, United States
Benchmark Research Ft. Worth
Fort Worth, Texas, 76135, United States
Benchmark Research San Angelo
San Angelo, Texas, 76904, United States
Jean Brown Research
Clinton, Utah, 84015, United States
Wee Care Pediatrics
Layton, Utah, 84041, United States
Cottonwood Pediatrics
Murray, Utah, 84107, United States
J. Lewis Research Inc.
Salt Lake City, Utah, 84109, United States
J. Lewis Research Inc.
Salt Lake City, Utah, 84121, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Copperview Medical Center
South Jordan, Utah, 84095, United States
Rockwood Clinic
Spokane, Washington, 99202, United States
Rockwood Clinic North
Spokane, Washington, 99218, United States
TASC Research Services Inc.
Surrey, British Columbia, V3R 8P8, Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3, Canada
Clinical Trials Research Center
Halifax, Nova Scotia, B3K 6R8, Canada
Colchester Regional Hospital
Truro, Nova Scotia, B2N 1L2, Canada
Albion Finch Medical Centre
Etobicoke, Ontario, M9V 4B4, Canada
Medicor Research Inc.
Greater Sudbury, Ontario, P3E 1H5, Canada
Children's Hospital of Western Ontario
London, Ontario, N6A 1V2, Canada
SKDS Research In.
Newmarket, Ontario, L3Y 5G8, Canada
Herridge Community Health Clinic
Ottawa, Ontario, K1S 0G8, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, N7T 4X3, Canada
Resolve Research Solutions
Toronto, Ontario, M5G 1N8, Canada
Resolve Research Solutions
Toronto, Ontario, M5M 1B2, Canada
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, C1A 8T5, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Commonwealth Medical Clinic
Mount Pearl, A1N 1W7, Canada
White Hills Medical Clinic
St. John's, A1A 3R5, Canada
Related Publications (1)
Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
PMID: 20943209RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY DIRECTOR
Novartis Vaccines and Diagnostics
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 15, 2008
Study Start
March 1, 2008
Primary Completion
April 1, 2009
Study Completion
October 1, 2009
Last Updated
February 15, 2016
Results First Posted
June 9, 2011
Record last verified: 2016-01