Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
NCT ID: NCT00626327
Last Updated: 2013-04-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1630 participants
INTERVENTIONAL
2008-02-29
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
NCT00667602
Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
NCT00806195
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.
NCT01682876
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
NCT00616421
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
NCT00310817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MenACWY-CRM+ MMRV
MenACWY-CRM + MMRV
One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.
MMRV
MMRV
one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
MenACWY-CRM
MenACWY-CRM
Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MenACWY-CRM + MMRV
One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.
MMRV
one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
MenACWY-CRM
Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* who have received complete primary vaccination with recommended licensed vaccines;
* who are available for all visits and telephone calls scheduled for the study;
Exclusion Criteria
* who had a previous or suspected disease caused by N. meningitidis;
* who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster;
* who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
* who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment;
* who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* who have previously received any measles, mumps, rubella or varicella vaccine either alone or in any combination;
* who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
* who have any serious acute, chronic or progressive disease such as, cancer, diabetes, heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome
* who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of the vaccine,
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired
* who have Down's syndrome or other known cytogenic disorders; bleeding diathesis
7 Months
1 Year
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Vaccines
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
Birmingham, Alabama, United States
Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
Dothan, Alabama, United States
Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
Greenville, Alabama, United States
Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
Montgomery, Alabama, United States
Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street
Bentonville, Arkansas, United States
Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601
Conway, Arkansas, United States
Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl
Jonesboro, Arkansas, United States
Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200
Little Rock, Arkansas, United States
Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265
Daly City, California, United States
Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor
Fresno, California, United States
Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120
Loma Linda, California, United States
Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street
Moreno Valley, California, United States
Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street
Oakland, California, United States
Site 72 - Children's Hospital of Orange Co. 455 South Main Street
Orange, California, United States
Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301
Paramount, California, United States
Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308
Paramount, California, United States
Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110
Redwood City, California, United States
Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24
Richmond, California, United States
Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies
Roseville, California, United States
Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road
Sacramento, California, United States
Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II
Sacramento, California, United States
Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C
Sacramento, California, United States
Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy
Santa Rosa, California, United States
Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.
Torrance, California, United States
Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1
Vallejo, California, United States
Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2
Walnut Creek, California, United States
Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C
Thornton, Colorado, United States
Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue
Thornton, Colorado, United States
Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike
Norwich, Connecticut, United States
Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141
Orlando, Florida, United States
Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102
Bardstown, Kentucky, United States
Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive
Crestview Hills, Kentucky, United States
Site 74 - University of Louisville University Child Health Specialists 230 East Broadway
Louisville, Kentucky, United States
Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street
Louisville, Kentucky, United States
Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100
Louisville, Kentucky, United States
Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2
Louisville, Kentucky, United States
Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101
Owensboro, Kentucky, United States
Site 68 - Physicians to Children/ Adolescents 102 West Depot Street
Springfield, Kentucky, United States
Site 93 - ACC Pediatric Research 1025 Highway 80 East
East Haughton, Louisiana, United States
Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway
New Orleans, Louisiana, United States
Site 39 - Pediatric Associates of Fall River, 829 S. Main Street
Fall River, Massachusetts, United States
Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street
Niles, Michigan, United States
Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1
Stevensville, Michigan, United States
Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255
Jackson, Mississippi, United States
Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street
Bellevue, Nebraska, United States
Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820
Omaha, Nebraska, United States
Site 78 - Children's Physicians Dundee 119 North 51st Street
Omaha, Nebraska, United States
Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210
Mineola, New York, United States
Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400
Syracuse, New York, United States
Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor
The Bronx, New York, United States
Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road
Durham, North Carolina, United States
Site 29 - Regional Pediatrics 4022 Freedom Lake Drive
Durham, North Carolina, United States
Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100
Durham, North Carolina, United States
Site 82 - Austintown Pediatrics 107 Javit Court
Austintown, Ohio, United States
Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014
Cincinnati, Ohio, United States
Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road
Cleveland, Ohio, United States
Site 97 - Dayton Clinical Research 1100 Salem Avenue
Dayton, Ohio, United States
Site 35 - Caro Pediatric Center 111 Turner Road
Dayton, Ohio, United States
Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C
Huber Heights, Ohio, United States
Site 27 - Ohio Pediatrics 1775 Delco Park Drive
Kettering, Ohio, United States
Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences
Tulsa, Oklahoma, United States
Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150
Gresham, Oregon, United States
Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900
Drexel Hill, Pennsylvania, United States
Site 13 - Children's Health Care- West 4671 West Lake Road
Erie, Pennsylvania, United States
Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street
Greenville, Pennsylvania, United States
Site 19 - Pediatric Associates of Latrobe 210 Welson Street
Latrobe, Pennsylvania, United States
Site 18 - Squirrel Hill Office 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, United States
Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100
Pittsburgh, Pennsylvania, United States
Site 20 - South Hill Pediatrics 4411 Stilley Road
Pittsburgh, Pennsylvania, United States
Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd
Pittsburgh, Pennsylvania, United States
Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120
Pittsburgh, Pennsylvania, United States
Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States
Site 16 - Laurel Pediatrics 140 Wayland Smith Drive
Uniontown, Pennsylvania, United States
Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207
Wexford, Pennsylvania, United States
Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C
Clarksville, Tennessee, United States
Site 11 - Focus Research Group 242 West Main
Hendersonville, Tennessee, United States
Site 38 - Jackson Clinic 2683 Highway 45 Bypass North
Jackson, Tennessee, United States
Site 69 - University of North Texas Health Science Center 855 Montgomery Street
Fort Worth, Texas, United States
Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
Houston, Texas, United States
Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100
Layton, Utah, United States
Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8
Layton, Utah, United States
Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza
Roy, Utah, United States
Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101
South Jordan, Utah, United States
Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008
Richmond, Virginia, United States
Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441
Seattle, Washington, United States
Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue
Spokane, Washington, United States
Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd
Spokane, Washington, United States
Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive
Huntington, West Virginia, United States
Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B
La Crosse, Wisconsin, United States
Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue
Monroe, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BB-IND 11278
Identifier Type: -
Identifier Source: secondary_id
V59P21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.