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

Primary Purpose

Meningococcal Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MenACWY-CRM + MMRV
MMRV
MenACWY-CRM
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Infections focused on measuring vaccine, toddlers, healthy, meningitis, meningococcal, measles, mumps, rubella, varicella, Prevention of Meningococcal disease types ACWY

Eligibility Criteria

7 Months - 1 Year (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
  • Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
  • Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
  • Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
  • Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street
  • Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601
  • Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl
  • Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200
  • Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265
  • Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor
  • Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120
  • Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street
  • Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street
  • Site 72 - Children's Hospital of Orange Co. 455 South Main Street
  • Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301
  • Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308
  • Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110
  • Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24
  • Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies
  • Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road
  • Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II
  • Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C
  • Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy
  • Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.
  • Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1
  • Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2
  • Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C
  • Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue
  • Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike
  • Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141
  • Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102
  • Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive
  • Site 74 - University of Louisville University Child Health Specialists 230 East Broadway
  • Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street
  • Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100
  • Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2
  • Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101
  • Site 68 - Physicians to Children/ Adolescents 102 West Depot Street
  • Site 93 - ACC Pediatric Research 1025 Highway 80 East
  • Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway
  • Site 39 - Pediatric Associates of Fall River, 829 S. Main Street
  • Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street
  • Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1
  • Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255
  • Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street
  • Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820
  • Site 78 - Children's Physicians Dundee 119 North 51st Street
  • Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor
  • Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210
  • Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400
  • Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road
  • Site 29 - Regional Pediatrics 4022 Freedom Lake Drive
  • Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100
  • Site 82 - Austintown Pediatrics 107 Javit Court
  • Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014
  • Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road
  • Site 97 - Dayton Clinical Research 1100 Salem Avenue
  • Site 35 - Caro Pediatric Center 111 Turner Road
  • Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C
  • Site 27 - Ohio Pediatrics 1775 Delco Park Drive
  • Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences
  • Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150
  • Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900
  • Site 13 - Children's Health Care- West 4671 West Lake Road
  • Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street
  • Site 19 - Pediatric Associates of Latrobe 210 Welson Street
  • Site 18 - Squirrel Hill Office 4070 Beechwood Blvd
  • Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100
  • Site 20 - South Hill Pediatrics 4411 Stilley Road
  • Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd
  • Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120
  • Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road
  • Site 16 - Laurel Pediatrics 140 Wayland Smith Drive
  • Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207
  • Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C
  • Site 11 - Focus Research Group 242 West Main
  • Site 38 - Jackson Clinic 2683 Highway 45 Bypass North
  • Site 69 - University of North Texas Health Science Center 855 Montgomery Street
  • Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
  • Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100
  • Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8
  • Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza
  • Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101
  • Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008
  • Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441
  • Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue
  • Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd
  • Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive
  • Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B
  • Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

MenACWY-CRM+ MMRV

MMRV

MenACWY-CRM

Arm Description

Outcomes

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
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.
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
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
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
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.
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.
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
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
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
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
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.

Full Information

First Posted
February 20, 2008
Last Updated
April 12, 2013
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00626327
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infections
Keywords
vaccine, toddlers, healthy, meningitis, meningococcal, measles, mumps, rubella, varicella, Prevention of Meningococcal disease types ACWY

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenACWY-CRM+ MMRV
Arm Type
Experimental
Arm Title
MMRV
Arm Type
Active Comparator
Arm Title
MenACWY-CRM
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM + MMRV
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
MMRV
Intervention Description
one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine
Description
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).
Time Frame
6 weeks post vaccination
Title
Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.
Description
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.
Time Frame
6 weeks post second dose
Title
Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine
Description
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.
Time Frame
6 weeks post vaccine dose 2
Secondary Outcome Measure Information:
Title
Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine
Description
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.
Time Frame
6 weeks post vaccine dose 2
Title
Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine
Description
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.
Time Frame
6 weeks post vaccine dose 2
Title
Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.
Description
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.
Time Frame
6 weeks post vaccination
Title
Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.
Description
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.
Time Frame
6 weeks post vaccination
Title
Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine
Description
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
Time Frame
1 month post vaccine dose 1
Title
Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine
Description
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.
Time Frame
1 month post vaccine dose 1
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination
Description
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.
Time Frame
upto 7 days after any vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Description
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.
Time Frame
Day 1- Day 180 (Through out the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
City
Greenville
State/Province
Alabama
ZIP/Postal Code
36037
Country
United States
Facility Name
Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Facility Name
Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street
City
Moreno Valley
State/Province
California
ZIP/Postal Code
92557
Country
United States
Facility Name
Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street
City
Oakland
State/Province
California
ZIP/Postal Code
94618
Country
United States
Facility Name
Site 72 - Children's Hospital of Orange Co. 455 South Main Street
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Site 74 - University of Louisville University Child Health Specialists 230 East Broadway
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40272
Country
United States
Facility Name
Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Site 68 - Physicians to Children/ Adolescents 102 West Depot Street
City
Springfield
State/Province
Kentucky
ZIP/Postal Code
40069
Country
United States
Facility Name
Site 93 - ACC Pediatric Research 1025 Highway 80 East
City
East Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Site 39 - Pediatric Associates of Fall River, 829 S. Main Street
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02724
Country
United States
Facility Name
Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1
City
Stevensville
State/Province
Michigan
ZIP/Postal Code
49127
Country
United States
Facility Name
Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Site 78 - Children's Physicians Dundee 119 North 51st Street
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
Facility Name
Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Site 29 - Regional Pediatrics 4022 Freedom Lake Drive
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Site 82 - Austintown Pediatrics 107 Javit Court
City
Austintown
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
Facility Name
Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Site 97 - Dayton Clinical Research 1100 Salem Avenue
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Site 35 - Caro Pediatric Center 111 Turner Road
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Site 27 - Ohio Pediatrics 1775 Delco Park Drive
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Site 13 - Children's Health Care- West 4671 West Lake Road
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
Site 19 - Pediatric Associates of Latrobe 210 Welson Street
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
Facility Name
Site 18 - Squirrel Hill Office 4070 Beechwood Blvd
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States
Facility Name
Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
Site 20 - South Hill Pediatrics 4411 Stilley Road
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
Facility Name
Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Site 16 - Laurel Pediatrics 140 Wayland Smith Drive
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Site 11 - Focus Research Group 242 West Main
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Site 38 - Jackson Clinic 2683 Highway 45 Bypass North
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Site 69 - University of North Texas Health Science Center 855 Montgomery Street
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B
City
LaCrosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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