Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00626327
First received: February 20, 2008
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Meningococcal Infections
Biological: MenACWY-CRM + MMRV
Biological: MMRV
Biological: MenACWY-CRM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccination ] [ Designated as safety issue: No ]

    Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.

    Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.

    Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella).


  • Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine. [ Time Frame: 6 weeks post second dose ] [ Designated as safety issue: No ]

    Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.

    The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).

    The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup.


  • Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccine dose 2 ] [ Designated as safety issue: No ]
    The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.


Secondary Outcome Measures:
  • Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccine dose 2 ] [ Designated as safety issue: No ]
    The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.

  • Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine [ Time Frame: 6 weeks post vaccine dose 2 ] [ Designated as safety issue: No ]
    The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.

  • Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine. [ Time Frame: 6 weeks post vaccination ] [ Designated as safety issue: No ]
    The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.

  • Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine. [ Time Frame: 6 weeks post vaccination ] [ Designated as safety issue: No ]

    The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .

    Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL.


  • Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine [ Time Frame: 1 month post vaccine dose 1 ] [ Designated as safety issue: No ]
    The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported

  • Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine [ Time Frame: 1 month post vaccine dose 1 ] [ Designated as safety issue: No ]
    The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.

  • Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination [ Time Frame: upto 7 days after any vaccination ] [ Designated as safety issue: Yes ]

    Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.

    Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature.


  • Number of Subjects Reporting Unsolicited Adverse Events After Vaccination [ Time Frame: Day 1- Day 180 (Through out the study) ] [ Designated as safety issue: Yes ]
    The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.


Enrollment: 1630
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM+ MMRV Biological: 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.
Active Comparator: MMRV Biological: MMRV
one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
Experimental: MenACWY-CRM Biological: 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

Ages Eligible for Study:   7 Months to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626327

  Hide Study Locations
Locations
United States, Alabama
Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
Birmingham, Alabama, United States, 35205
Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
Dothan, Alabama, United States, 36305
Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
Greenville, Alabama, United States, 36037
Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
Montgomery, Alabama, United States, 36106
United States, Arkansas
Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street
Bentonville, Arkansas, United States, 72712
Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601
Conway, Arkansas, United States, 72034
Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl
Jonesboro, Arkansas, United States, 72401
Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200
Little Rock, Arkansas, United States, 72205
United States, California
Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265
Daly City, California, United States, 94015
Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor
Fresno, California, United States, 93726
Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120
Loma Linda, California, United States, 92350
Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street
Moreno Valley, California, United States, 92557
Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street
Oakland, California, United States, 94618
Site 72 - Children's Hospital of Orange Co. 455 South Main Street
Orange, California, United States, 92868
Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301
Paramount, California, United States, 90723
Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308
Paramount, California, United States, 90723
Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110
Redwood City, California, United States, 94063
Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24
Richmond, California, United States, 94801
Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies
Roseville, California, United States, 95661
Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road
Sacramento, California, United States, 95815
Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C
Sacramento, California, United States, 95823
Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II
Sacramento, California, United States, 95817
Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy
Santa Rosa, California, United States, 95403
Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.
Torrance, California, United States, 90502
Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1
Vallejo, California, United States, 94589
Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2
Walnut Creek, California, United States, 94596
United States, Colorado
Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C
Thornton, Colorado, United States, 80233
Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue
Thornton, Colorado, United States, 80233
United States, Connecticut
Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike
Norwich, Connecticut, United States, 06360
United States, Florida
Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141
Orlando, Florida, United States, 32806
United States, Kentucky
Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102
Bardstown, Kentucky, United States, 40004
Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive
Crestview Hills, Kentucky, United States, 41017
Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2
Louisville, Kentucky, United States, 40291
Site 74 - University of Louisville University Child Health Specialists 230 East Broadway
Louisville, Kentucky, United States, 40202
Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100
Louisville, Kentucky, United States, 40272
Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street
Louisville, Kentucky, United States, 40202
Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101
Owensboro, Kentucky, United States, 42303
Site 68 - Physicians to Children/ Adolescents 102 West Depot Street
Springfield, Kentucky, United States, 40069
United States, Louisiana
Site 93 - ACC Pediatric Research 1025 Highway 80 East
East Haughton, Louisiana, United States, 71037
Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Site 39 - Pediatric Associates of Fall River, 829 S. Main Street
Fall River, Massachusetts, United States, 02724
United States, Michigan
Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street
Niles, Michigan, United States, 49120
Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1
Stevensville, Michigan, United States, 49127
United States, Mississippi
Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255
Jackson, Mississippi, United States, 39216
United States, Nebraska
Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street
Bellevue, Nebraska, United States, 68123
Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820
Omaha, Nebraska, United States, 68131
Site 78 - Children's Physicians Dundee 119 North 51st Street
Omaha, Nebraska, United States, 68132
United States, New York
Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor
Bronx, New York, United States, 10467
Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210
Mineola, New York, United States, 11501
Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400
Syracuse, New York, United States, 13210
United States, North Carolina
Site 29 - Regional Pediatrics 4022 Freedom Lake Drive
Durham, North Carolina, United States, 27704
Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road
Durham, North Carolina, United States, 27704
Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100
Durham, North Carolina, United States, 27704
United States, Ohio
Site 82 - Austintown Pediatrics 107 Javit Court
Austintown, Ohio, United States, 44515
Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014
Cincinnati, Ohio, United States, 45229
Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road
Cleveland, Ohio, United States, 44121
Site 35 - Caro Pediatric Center 111 Turner Road
Dayton, Ohio, United States, 45415
Site 97 - Dayton Clinical Research 1100 Salem Avenue
Dayton, Ohio, United States, 45406
Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C
Huber Heights, Ohio, United States, 45424
Site 27 - Ohio Pediatrics 1775 Delco Park Drive
Kettering, Ohio, United States, 45420
United States, Oklahoma
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, 74127
United States, Oregon
Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900
Drexel Hill, Pennsylvania, United States, 19026
Site 13 - Children's Health Care- West 4671 West Lake Road
Erie, Pennsylvania, United States, 16505
Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street
Greenville, Pennsylvania, United States, 16125
Site 19 - Pediatric Associates of Latrobe 210 Welson Street
Latrobe, Pennsylvania, United States, 15650
Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States, 15241
Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd
Pittsburgh, Pennsylvania, United States, 15236
Site 18 - Squirrel Hill Office 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, United States, 15217
Site 20 - South Hill Pediatrics 4411 Stilley Road
Pittsburgh, Pennsylvania, United States, 15227
Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120
Pittsburgh, Pennsylvania, United States, 15237
Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100
Pittsburgh, Pennsylvania, United States, 15220
Site 16 - Laurel Pediatrics 140 Wayland Smith Drive
Uniontown, Pennsylvania, United States, 15401
Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207
Wexford, Pennsylvania, United States, 15090
United States, Tennessee
Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C
Clarksville, Tennessee, United States, 37043
Site 11 - Focus Research Group 242 West Main
Hendersonville, Tennessee, United States, 37075
Site 38 - Jackson Clinic 2683 Highway 45 Bypass North
Jackson, Tennessee, United States, 38305
United States, Texas
Site 69 - University of North Texas Health Science Center 855 Montgomery Street
Fort Worth, Texas, United States, 76107
Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
Houston, Texas, United States, 77070
United States, Utah
Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100
Layton, Utah, United States, 84041
Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8
Layton, Utah, United States, 84041
Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza
Roy, Utah, United States, 84067
Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101
South Jordan, Utah, United States, 84095
United States, Virginia
Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008
Richmond, Virginia, United States, 23219
United States, Washington
Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441
Seattle, Washington, United States, 98105
Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd
Spokane, Washington, United States, 99218
Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue
Spokane, Washington, United States, 99202
United States, West Virginia
Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B
LaCrosse, Wisconsin, United States, 54601
Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00626327     History of Changes
Other Study ID Numbers: V59P21, BB-IND 11278
Study First Received: February 20, 2008
Results First Received: February 12, 2013
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
vaccine
toddlers
healthy
meningitis
meningococcal
measles
mumps
rubella
varicella
Prevention of Meningococcal disease types ACWY

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 20, 2014