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

NCT00626327 | Completed Phase 3 Results

• 2 other identifiers: V59P21BB-IND 11278
• Study Type: interventional
• Target: 1,630
• Locations: 1 country
• Sites: 90

Brief Summary

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

Conditions

Meningococcal Infections

Keywords

vaccine; toddlers; healthy; meningitis; meningococcal; measles; mumps; rubella; varicella; Prevention of Meningococcal disease types ACWY

Outcome Measures

Primary Outcomes (3)

• Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine

  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).

  6 weeks post vaccination

• Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.

  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.

  6 weeks post second dose

• Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine

  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.

  6 weeks post vaccine dose 2

Secondary Outcomes (8)

• Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine

  6 weeks post vaccine dose 2

• Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine

  6 weeks post vaccine dose 2

• Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.

  6 weeks post vaccination

• Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.

  6 weeks post vaccination

• Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine

  1 month post vaccine dose 1

Study Arms (3)

MenACWY-CRM+ MMRV

EXPERIMENTAL

Biological: MenACWY-CRM + MMRV

MMRV

ACTIVE COMPARATOR

Biological: MMRV

MenACWY-CRM

EXPERIMENTAL

Biological: MenACWY-CRM

Interventions

MenACWY-CRM + MMRV BIOLOGICAL

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.

MenACWY-CRM+ MMRV

MMRV BIOLOGICAL

one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age

MMRV

MenACWY-CRM BIOLOGICAL

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

MenACWY-CRM

Eligibility Criteria

• Age: 7 Months - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (90)

Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive

Birmingham, Alabama, 35205, United States

Location

Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road

Dothan, Alabama, 36305, United States

Location

Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,

Greenville, Alabama, 36037, United States

Location

Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200

Montgomery, Alabama, 36106, United States

Location

Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street

Bentonville, Arkansas, 72712, United States

Location

Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601

Conway, Arkansas, 72034, United States

Location

Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl

Jonesboro, Arkansas, 72401, United States

Location

Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200

Little Rock, Arkansas, 72205, United States

Location

Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265

Daly City, California, 94015, United States

Location

Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor

Fresno, California, 93726, United States

Location

Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120

Loma Linda, California, 92350, United States

Location

Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street

Moreno Valley, California, 92557, United States

Location

Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street

Oakland, California, 94618, United States

Location

Site 72 - Children's Hospital of Orange Co. 455 South Main Street

Orange, California, 92868, United States

Location

Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301

Paramount, California, 90723, United States

Location

Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308

Paramount, California, 90723, United States

Location

Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110

Redwood City, California, 94063, United States

Location

Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24

Richmond, California, 94801, United States

Location

Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies

Roseville, California, 95661, United States

Location

Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road

Sacramento, California, 95815, United States

Location

Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II

Sacramento, California, 95817, United States

Location

Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C

Sacramento, California, 95823, United States

Location

Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy

Santa Rosa, California, 95403, United States

Location

Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.

Torrance, California, 90502, United States

Location

Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1

Vallejo, California, 94589, United States

Location

Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2

Walnut Creek, California, 94596, United States

Location

Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C

Thornton, Colorado, 80233, United States

Location

Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue

Thornton, Colorado, 80233, United States

Location

Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike

Norwich, Connecticut, 06360, United States

Location

Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141

Orlando, Florida, 32806, United States

Location

Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102

Bardstown, Kentucky, 40004, United States

Location

Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive

Crestview Hills, Kentucky, 41017, United States

Location

Site 74 - University of Louisville University Child Health Specialists 230 East Broadway

Louisville, Kentucky, 40202, United States

Location

Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street

Louisville, Kentucky, 40202, United States

Location

Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100

Louisville, Kentucky, 40272, United States

Location

Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2

Louisville, Kentucky, 40291, United States

Location

Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101

Owensboro, Kentucky, 42303, United States

Location

Site 68 - Physicians to Children/ Adolescents 102 West Depot Street

Springfield, Kentucky, 40069, United States

Location

Site 93 - ACC Pediatric Research 1025 Highway 80 East

East Haughton, Louisiana, 71037, United States

Location

Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway

New Orleans, Louisiana, 70121, United States

Location

Site 39 - Pediatric Associates of Fall River, 829 S. Main Street

Fall River, Massachusetts, 02724, United States

Location

Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street

Niles, Michigan, 49120, United States

Location

Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1

Stevensville, Michigan, 49127, United States

Location

Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255

Jackson, Mississippi, 39216, United States

Location

Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street

Bellevue, Nebraska, 68123, United States

Location

Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820

Omaha, Nebraska, 68131, United States

Location

Site 78 - Children's Physicians Dundee 119 North 51st Street

Omaha, Nebraska, 68132, United States

Location

Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210

Mineola, New York, 11501, United States

Location

Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400

Syracuse, New York, 13210, United States

Location

Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor

The Bronx, New York, 10467, United States

Location

Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road

Durham, North Carolina, 27704, United States

Location

Site 29 - Regional Pediatrics 4022 Freedom Lake Drive

Durham, North Carolina, 27704, United States

Location

Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100

Durham, North Carolina, 27704, United States

Location

Site 82 - Austintown Pediatrics 107 Javit Court

Austintown, Ohio, 44515, United States

Location

Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014

Cincinnati, Ohio, 45229, United States

Location

Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road

Cleveland, Ohio, 44121, United States

Location

Site 97 - Dayton Clinical Research 1100 Salem Avenue

Dayton, Ohio, 45406, United States

Location

Site 35 - Caro Pediatric Center 111 Turner Road

Dayton, Ohio, 45415, United States

Location

Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C

Huber Heights, Ohio, 45424, United States

Location

Site 27 - Ohio Pediatrics 1775 Delco Park Drive

Kettering, Ohio, 45420, United States

Location

Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences

Tulsa, Oklahoma, 74127, United States

Location

Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150

Gresham, Oregon, 97030, United States

Location

Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900

Drexel Hill, Pennsylvania, 19026, United States

Location

Site 13 - Children's Health Care- West 4671 West Lake Road

Erie, Pennsylvania, 16505, United States

Location

Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street

Greenville, Pennsylvania, 16125, United States

Location

Site 19 - Pediatric Associates of Latrobe 210 Welson Street

Latrobe, Pennsylvania, 15650, United States

Location

Site 18 - Squirrel Hill Office 4070 Beechwood Blvd

Pittsburgh, Pennsylvania, 15217, United States

Location

Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100

Pittsburgh, Pennsylvania, 15220, United States

Location

Site 20 - South Hill Pediatrics 4411 Stilley Road

Pittsburgh, Pennsylvania, 15227, United States

Location

Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd

Pittsburgh, Pennsylvania, 15236, United States

Location

Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120

Pittsburgh, Pennsylvania, 15237, United States

Location

Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road

Pittsburgh, Pennsylvania, 15241, United States

Location

Site 16 - Laurel Pediatrics 140 Wayland Smith Drive

Uniontown, Pennsylvania, 15401, United States

Location

Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207

Wexford, Pennsylvania, 15090, United States

Location

Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C

Clarksville, Tennessee, 37043, United States

Location

Site 11 - Focus Research Group 242 West Main

Hendersonville, Tennessee, 37075, United States

Location

Site 38 - Jackson Clinic 2683 Highway 45 Bypass North

Jackson, Tennessee, 38305, United States

Location

Site 69 - University of North Texas Health Science Center 855 Montgomery Street

Fort Worth, Texas, 76107, United States

Location

Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200

Houston, Texas, 77070, United States

Location

Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100

Layton, Utah, 84041, United States

Location

Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8

Layton, Utah, 84041, United States

Location

Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza

Roy, Utah, 84067, United States

Location

Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101

South Jordan, Utah, 84095, United States

Location

Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008

Richmond, Virginia, 23219, United States

Location

Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441

Seattle, Washington, 98105, United States

Location

Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue

Spokane, Washington, 99202, United States

Location

Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd

Spokane, Washington, 99218, United States

Location

Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive

Huntington, West Virginia, 25701, United States

Location

Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B

La Crosse, Wisconsin, 54601, United States

Location

Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue

Monroe, Wisconsin, 53566, United States

Location

MeSH Terms

Conditions

Meningococcal Infections; Meningitis; Measles; Mumps; Rubella; Chickenpox

Interventions

measles, mumps, rubella, varicella vaccine; MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 19, 2013
• Results First Posted: March 15, 2013

Record last verified: 2013-04

Locations

US (90)