Clinical trial NCT00626327: Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
Official title: A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Infections
Keywords: vaccine
toddlers
healthy
meningitis
meningococcal
measles
mumps
rubella
varicella
Prevention of Meningococcal disease types ACWY
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 1630
Sex: ALL
Minimum age (years): 7
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers


Eligibility criteria: Inclusion Criteria:

* who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent;
* 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:

* whose parent or legal guardian is unwilling or unable to give written informed assent consent
* 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

Primary outcomes:
measure: Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine
timeFrame: 6 weeks post vaccination
measure: Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.
timeFrame: 6 weeks post second dose
measure: Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine
timeFrame: 6 weeks post vaccine dose 2
Secondary outcomes:
measure: Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine
timeFrame: 6 weeks post vaccine dose 2
measure: Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine
timeFrame: 6 weeks post vaccine dose 2
measure: Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.
timeFrame: 6 weeks post vaccination
measure: Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.
timeFrame: 6 weeks post vaccination
measure: Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine
timeFrame: 1 month post vaccine dose 1
measure: Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine
timeFrame: 1 month post vaccine dose 1
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination
timeFrame: upto 7 days after any vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
timeFrame: Day 1- Day 180 (Through out the study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
state: Alabama
city: Dothan
country: United States
facility: Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
state: Alabama
city: Greenville
country: United States
facility: Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
state: Alabama
city: Montgomery
country: United States
facility: Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
state: Alabama
city: Bentonville
country: United States
facility: Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street
state: Arkansas
city: Conway
country: United States
facility: Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601
state: Arkansas
city: Jonesboro
country: United States
facility: Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl
state: Arkansas
city: Little Rock
country: United States
facility: Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200
state: Arkansas
city: Daly City
country: United States
facility: Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265
state: California
city: Fresno
country: United States
facility: Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor
state: California
city: Loma Linda
country: United States
facility: Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120
state: California
city: Moreno Valley
country: United States
facility: Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street
state: California
city: Oakland
country: United States
facility: Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street
state: California
city: Orange
country: United States
facility: Site 72 - Children's Hospital of Orange Co. 455 South Main Street
state: California
city: Paramount
country: United States
facility: Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301
state: California
city: Paramount
country: United States
facility: Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308
state: California
city: Redwood City
country: United States
facility: Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110
state: California
city: Richmond
country: United States
facility: Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24
state: California
city: Roseville
country: United States
facility: Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies
state: California
city: Sacramento
country: United States
facility: Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road
state: California
city: Sacramento
country: United States
facility: Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II
state: California
city: Sacramento
country: United States
facility: Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C
state: California
city: Santa Rosa
country: United States
facility: Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy
state: California
city: Torrance
country: United States
facility: Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.
state: California
city: Vallejo
country: United States
facility: Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1
state: California
city: Walnut Creek
country: United States
facility: Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2
state: California
city: Thornton
country: United States
facility: Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C
state: Colorado
city: Thornton
country: United States
facility: Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue
state: Colorado
city: Norwich
country: United States
facility: Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike
state: Connecticut
city: Orlando
country: United States
facility: Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141
state: Florida
city: Bardstown
country: United States
facility: Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102
state: Kentucky
city: Crestview Hills
country: United States
facility: Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive
state: Kentucky
city: Louisville
country: United States
facility: Site 74 - University of Louisville University Child Health Specialists 230 East Broadway
state: Kentucky
city: Louisville
country: United States
facility: Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street
state: Kentucky
city: Louisville
country: United States
facility: Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100
state: Kentucky
city: Louisville
country: United States
facility: Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2
state: Kentucky
city: Owensboro
country: United States
facility: Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101
state: Kentucky
city: Springfield
country: United States
facility: Site 68 - Physicians to Children/ Adolescents 102 West Depot Street
state: Kentucky
city: East Haughton
country: United States
facility: Site 93 - ACC Pediatric Research 1025 Highway 80 East
state: Louisiana
city: New Orleans
country: United States
facility: Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway
state: Louisiana
city: Fall River
country: United States
facility: Site 39 - Pediatric Associates of Fall River, 829 S. Main Street
state: Massachusetts
city: Niles
country: United States
facility: Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street
state: Michigan
city: Stevensville
country: United States
facility: Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1
state: Michigan
city: Jackson
country: United States
facility: Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255
state: Mississippi
city: Bellevue
country: United States
facility: Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street
state: Nebraska
city: Omaha
country: United States
facility: Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820
state: Nebraska
city: Omaha
country: United States
facility: Site 78 - Children's Physicians Dundee 119 North 51st Street
state: Nebraska
city: Bronx
country: United States
facility: Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor
state: New York
city: Mineola
country: United States
facility: Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210
state: New York
city: Syracuse
country: United States
facility: Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400
state: New York
city: Durham
country: United States
facility: Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road
state: North Carolina
city: Durham
country: United States
facility: Site 29 - Regional Pediatrics 4022 Freedom Lake Drive
state: North Carolina
city: Durham
country: United States
facility: Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100
state: North Carolina
city: Austintown
country: United States
facility: Site 82 - Austintown Pediatrics 107 Javit Court
state: Ohio
city: Cincinnati
country: United States
facility: Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014
state: Ohio
city: Cleveland
country: United States
facility: Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road
state: Ohio
city: Dayton
country: United States
facility: Site 97 - Dayton Clinical Research 1100 Salem Avenue
state: Ohio
city: Dayton
country: United States
facility: Site 35 - Caro Pediatric Center 111 Turner Road
state: Ohio
city: Huber Heights
country: United States
facility: Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C
state: Ohio
city: Kettering
country: United States
facility: Site 27 - Ohio Pediatrics 1775 Delco Park Drive
state: Ohio
city: Tulsa
country: United States
facility: Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences
state: Oklahoma
city: Gresham
country: United States
facility: Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150
state: Oregon
city: Drexel Hill
country: United States
facility: Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900
state: Pennsylvania
city: Erie
country: United States
facility: Site 13 - Children's Health Care- West 4671 West Lake Road
state: Pennsylvania
city: Greenville
country: United States
facility: Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street
state: Pennsylvania
city: Latrobe
country: United States
facility: Site 19 - Pediatric Associates of Latrobe 210 Welson Street
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 18 - Squirrel Hill Office 4070 Beechwood Blvd
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 20 - South Hill Pediatrics 4411 Stilley Road
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road
state: Pennsylvania
city: Uniontown
country: United States
facility: Site 16 - Laurel Pediatrics 140 Wayland Smith Drive
state: Pennsylvania
city: Wexford
country: United States
facility: Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207
state: Pennsylvania
city: Clarksville
country: United States
facility: Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C
state: Tennessee
city: Hendersonville
country: United States
facility: Site 11 - Focus Research Group 242 West Main
state: Tennessee
city: Jackson
country: United States
facility: Site 38 - Jackson Clinic 2683 Highway 45 Bypass North
state: Tennessee
city: Fort Worth
country: United States
facility: Site 69 - University of North Texas Health Science Center 855 Montgomery Street
state: Texas
city: Houston
country: United States
facility: Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
state: Texas
city: Layton
country: United States
facility: Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100
state: Utah
city: Layton
country: United States
facility: Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8
state: Utah
city: Roy
country: United States
facility: Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza
state: Utah
city: South Jordan
country: United States
facility: Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101
state: Utah
city: Richmond
country: United States
facility: Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008
state: Virginia
city: Seattle
country: United States
facility: Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441
state: Washington
city: Spokane
country: United States
facility: Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue
state: Washington
city: Spokane
country: United States
facility: Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd
state: Washington
city: Huntington
country: United States
facility: Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive
state: West Virginia
city: LaCrosse
country: United States
facility: Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B
state: Wisconsin
city: Monroe
country: United States
facility: Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue
state: Wisconsin
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: