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Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

Primary Purpose

Meningococcal Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MenACWY-CRM
MenACWY-CRM
Licensed meningococcal ACWY vaccine
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, children, healthy, meningitis, meningococcal, prevention of meningococcal disease serogroups ACWY, Menveo

Eligibility Criteria

2 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
  • who are available for all visits and telephone calls scheduled for the study
  • who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

  • whose parent or legal guardian is unwilling or unable to give written informed consent
  • who had a previous or suspected disease caused by N. meningitidis;
  • who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • who have received any investigational agents or vaccines within 90 days prior to enrollment
  • who have any serious acute, chronic or progressive disease
  • who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
  • who have a history of anaphylaxis, serious vaccine reactions
  • who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
  • who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
  • who have Down's syndrome or other known cytogenic disorders

Sites / Locations

  • Children's Investigational Reserach Program
  • Arkansas Pediatric Research Group
  • Premier Health Research Center
  • Kaiser Permanente - Fremont
  • Kaiser Permanente - Fresno
  • Kaiser Permanente - Hayward
  • Kaiser Permanente - Oakland
  • Kaiser Permanente - Pleasanton
  • Kaiser Permanente - San Francisco
  • Kaiser Permanente - San Jose
  • Kaiser Permanente - Aurora
  • 1st Allergy & Clinical Research
  • Longmont Medical Research Network
  • 1st Allergy & Clinical Research
  • Kaiser Permanente - Westminister
  • Kentucky Pediatric Research Center
  • Physicians to Children & Adolescents
  • Benchmark Research
  • St. Louis University School of Medicine
  • Meridian Clinical Research LLC
  • Legacy Pediatrics
  • Duke University Medical Center
  • Durham Pediatrics
  • Regional Pediatric Associates PA
  • Odyssey Research
  • Dr. Senders and Associates
  • Calcagno Research & Development
  • Children's Health Care - West
  • University Of Pittsburgh Medical Center
  • Family Healthcare Partners
  • Pediatric Associates of Latrobe
  • Pediatric Alliance PC
  • Pediatric Alliance PC
  • South Hills Pediatrics
  • Pediatric Alliance PC
  • Primary Physicians Research Inc.
  • Primary Physicians Research Inc.
  • Laurel Pediatrics
  • Family Practice Medical Associates South
  • Children's Community Pediatrics
  • Jackson Clinic Professional Association
  • Benchmark Research Ft. Worth
  • Benchmark Research San Angelo
  • Jean Brown Research
  • Wee Care Pediatrics
  • Cottonwood Pediatrics
  • J. Lewis Research Inc.
  • J. Lewis Research Inc.
  • Jean Brown Research
  • Copperview Medical Center
  • Rockwood Clinic
  • Rockwood Clinic North
  • TASC Research Services Inc.
  • Manitoba Clinic
  • Clinical Trials Research Center
  • Colchester Regional Hospital
  • Albion Finch Medical Centre
  • Children's Hospital of Western Ontario
  • SKDS Research In.
  • Herridge Community Health Clinic
  • Sarnia Institute of Clinical Research
  • Medicor Research Inc.
  • Resolve Research Solutions
  • Resolve Research Solutions
  • Queen Elizabeth Hospital
  • Royal University Hospital
  • Commonwealth Medical Clinic
  • White Hills Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

MenACWY-CRM (1 dose)

Licensed polysaccharide vaccine

MenACWY-CRM (2 doses)

Arm Description

1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.

1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1

2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.

Outcomes

Primary Outcome Measures

Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

Secondary Outcome Measures

Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.

Full Information

First Posted
January 31, 2008
Last Updated
January 19, 2016
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00616421
Brief Title
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Official Title
A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infections
Keywords
vaccine, children, healthy, meningitis, meningococcal, prevention of meningococcal disease serogroups ACWY, Menveo

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2907 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenACWY-CRM (1 dose)
Arm Type
Experimental
Arm Description
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.
Arm Title
Licensed polysaccharide vaccine
Arm Type
Active Comparator
Arm Description
1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1
Arm Title
MenACWY-CRM (2 doses)
Arm Type
Experimental
Arm Description
2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Other Intervention Name(s)
Menveo
Intervention Description
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Other Intervention Name(s)
Menveo
Intervention Description
2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
Intervention Type
Biological
Intervention Name(s)
Licensed meningococcal ACWY vaccine
Other Intervention Name(s)
Menactra
Intervention Description
1 injection of the licensed meningococcal ACWY was administered intramuscularly
Primary Outcome Measure Information:
Title
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Description
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month postvaccination
Title
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Description
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month postvaccination
Secondary Outcome Measure Information:
Title
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Description
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month postvaccination
Title
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Description
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month postvaccination
Title
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
Description
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame
1 month postvaccination
Title
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Description
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame
1 month postvaccination
Title
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Description
The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame
1 month postvaccination
Title
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Description
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month postvaccination
Title
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Description
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time Frame
1 month postvaccination
Title
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Description
The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.
Time Frame
1 month postvaccination
Title
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Description
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.
Time Frame
Study days 1 to 7
Title
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Description
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.
Time Frame
Study days 1 to 7
Title
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Description
Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.
Time Frame
day 1 to study termination (day 240)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent who are available for all visits and telephone calls scheduled for the study who are up-to-date with age-appropriate routine childhood vaccinations Exclusion Criteria: whose parent or legal guardian is unwilling or unable to give written informed consent who had a previous or suspected disease caused by N. meningitidis; who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) who have received any investigational agents or vaccines within 90 days prior to enrollment who have any serious acute, chronic or progressive disease who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome who have a history of anaphylaxis, serious vaccine reactions who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time who have Down's syndrome or other known cytogenic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Children's Investigational Reserach Program
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Arkansas Pediatric Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Premier Health Research Center
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Kaiser Permanente - Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Kaiser Permanente - Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Kaiser Permanente - Hayward
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Kaiser Permanente - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente - Pleasanton
City
Pleasanton
State/Province
California
ZIP/Postal Code
94566
Country
United States
Facility Name
Kaiser Permanente - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente - San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
1st Allergy & Clinical Research
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
1st Allergy & Clinical Research
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Kaiser Permanente - Westminister
City
Westminister
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Facility Name
Kentucky Pediatric Research Center
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Physicians to Children & Adolescents
City
Springfield
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
St. Louis University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Legacy Pediatrics
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Durham Pediatrics
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Regional Pediatric Associates PA
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Odyssey Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Dr. Senders and Associates
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Calcagno Research & Development
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Children's Health Care - West
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
University Of Pittsburgh Medical Center
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
Family Healthcare Partners
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
Facility Name
Pediatric Associates of Latrobe
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
Facility Name
Pediatric Alliance PC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States
Facility Name
Pediatric Alliance PC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
South Hills Pediatrics
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
Facility Name
Pediatric Alliance PC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Primary Physicians Research Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Primary Physicians Research Inc.
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
Laurel Pediatrics
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Family Practice Medical Associates South
City
Upper St. Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Children's Community Pediatrics
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Jackson Clinic Professional Association
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Benchmark Research Ft. Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Benchmark Research San Angelo
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Jean Brown Research
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Cottonwood Pediatrics
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
J. Lewis Research Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Copperview Medical Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Rockwood Clinic North
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
TASC Research Services Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 8P8
Country
Canada
Facility Name
Manitoba Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Clinical Trials Research Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Colchester Regional Hospital
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Albion Finch Medical Centre
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 1V2
Country
Canada
Facility Name
SKDS Research In.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Herridge Community Health Clinic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1S 0G8
Country
Canada
Facility Name
Sarnia Institute of Clinical Research
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Medicor Research Inc.
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
Resolve Research Solutions
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Facility Name
Resolve Research Solutions
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5M 1B2
Country
Canada
Facility Name
Queen Elizabeth Hospital
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Commonwealth Medical Clinic
City
Mount Pearl
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
White Hills Medical Clinic
City
Saint John's
ZIP/Postal Code
A1A 3R5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20943209
Citation
Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
Results Reference
result

Learn more about this trial

Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

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