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

Meningococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626327
• Other study ID #: V59P21
• Secondary ID: BB-IND 11278
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2008
• Last updated: April 12, 2013
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1630
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Months to 1 Year

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Meningococcal Infections

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Site 82 - Austintown Pediatrics 107 Javit Court	Austintown	Ohio
United States	Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102	Bardstown	Kentucky
United States	Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street	Bellevue	Nebraska
United States	Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street	Bentonville	Arkansas
United States	Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive	Birmingham	Alabama
United States	Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor	Bronx	New York
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 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C	Clarksville	Tennessee
United States	Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road	Cleveland	Ohio
United States	Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601	Conway	Arkansas
United States	Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive	Crestview Hills	Kentucky
United States	Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265	Daly City	California
United States	Site 35 - Caro Pediatric Center 111 Turner Road	Dayton	Ohio
United States	Site 97 - Dayton Clinical Research 1100 Salem Avenue	Dayton	Ohio
United States	Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road	Dothan	Alabama
United States	Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900	Drexel Hill	Pennsylvania
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 93 - ACC Pediatric Research 1025 Highway 80 East	East Haughton	Louisiana
United States	Site 13 - Children's Health Care- West 4671 West Lake Road	Erie	Pennsylvania
United States	Site 39 - Pediatric Associates of Fall River, 829 S. Main Street	Fall River	Massachusetts
United States	Site 69 - University of North Texas Health Science Center 855 Montgomery Street	Fort Worth	Texas
United States	Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor	Fresno	California
United States	Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,	Greenville	Alabama
United States	Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street	Greenville	Pennsylvania
United States	Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150	Gresham	Oregon
United States	Site 11 - Focus Research Group 242 West Main	Hendersonville	Tennessee
United States	Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200	Houston	Texas
United States	Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C	Huber Heights	Ohio
United States	Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive	Huntington	West Virginia
United States	Site 38 - Jackson Clinic 2683 Highway 45 Bypass North	Jackson	Tennessee
United States	Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255	Jackson	Mississippi
United States	Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl	Jonesboro	Arkansas
United States	Site 27 - Ohio Pediatrics 1775 Delco Park Drive	Kettering	Ohio
United States	Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B	LaCrosse	Wisconsin
United States	Site 19 - Pediatric Associates of Latrobe 210 Welson Street	Latrobe	Pennsylvania
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 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200	Little Rock	Arkansas
United States	Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120	Loma Linda	California
United States	Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2	Louisville	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 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210	Mineola	New York
United States	Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue	Monroe	Wisconsin
United States	Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200	Montgomery	Alabama
United States	Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street	Moreno Valley	California
United States	Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway	New Orleans	Louisiana
United States	Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street	Niles	Michigan
United States	Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike	Norwich	Connecticut
United States	Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street	Oakland	California
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 72 - Children's Hospital of Orange Co. 455 South Main Street	Orange	California
United States	Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141	Orlando	Florida
United States	Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101	Owensboro	Kentucky
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 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road	Pittsburgh	Pennsylvania
United States	Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd	Pittsburgh	Pennsylvania
United States	Site 18 - Squirrel Hill Office 4070 Beechwood Blvd	Pittsburgh	Pennsylvania
United States	Site 20 - South Hill Pediatrics 4411 Stilley Road	Pittsburgh	Pennsylvania
United States	Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100	Pittsburgh	Pennsylvania
United States	Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120	Pittsburgh	Pennsylvania
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 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008	Richmond	Virginia
United States	Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies	Roseville	California
United States	Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza	Roy	Utah
United States	Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road	Sacramento	California
United States	Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C	Sacramento	California
United States	Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II	Sacramento	California
United States	Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy	Santa Rosa	California
United States	Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441	Seattle	Washington
United States	Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101	South Jordan	Utah
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 68 - Physicians to Children/ Adolescents 102 West Depot Street	Springfield	Kentucky
United States	Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1	Stevensville	Michigan
United States	Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400	Syracuse	New York
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 24 - UCLA Center for Vaccine Research 1124 W Carson St.	Torrance	California
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 16 - Laurel Pediatrics 140 Wayland Smith Drive	Uniontown	Pennsylvania
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 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Percentages of Subjects With hSBA =1:4 After Two Doses of MenACWY-CRM Vaccine	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.	6 weeks post vaccine dose 2	No
Secondary	Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine	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.	6 weeks post vaccine dose 2	No
Secondary	Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.	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.	6 weeks post vaccination	No
Secondary	Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.	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.	6 weeks post vaccination	No
Secondary	Percentages of Subjects With hSBA =1:4 and hSBA =1:8 Following One Dose of MenACWY-CRM Vaccine	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	1 month post vaccine dose 1	No
Secondary	Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine	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.	1 month post vaccine dose 1	No
Secondary	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination	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.	upto 7 days after any vaccination	Yes
Secondary	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	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.	Day 1- Day 180 (Through out the study)	Yes