Back to resultsStudy of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Primary Purpose
Prevention of Meningococcal Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MenACWY-CRM Vaccine
MenACWY-PS Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Meningococcal Disease
Eligibility Criteria
Inclusion Criteria: Group 1: Healthy children 2-10 years of age; Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus. Exclusion Criteria: Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease. Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Sites / Locations
- Kaiser Permanente Vaccine Study Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Experimental
Arm Label
MenACWY-CRM (2-10 years)
MenACWY-CRM (12-23 months)
MenACWY-PS (2-10 years)
MenACWY-CRM+PnC (12-15 months)
MenACWY-CRM+DTaP (16-23 months)
Arm Description
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine
Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC
Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP
Outcomes
Primary Outcome Measures
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Secondary Outcome Measures
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00262028
Brief Title
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Official Title
A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Meningococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
910 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MenACWY-CRM (2-10 years)
Arm Type
Experimental
Arm Description
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
Arm Title
MenACWY-CRM (12-23 months)
Arm Type
Experimental
Arm Description
Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
Arm Title
MenACWY-PS (2-10 years)
Arm Type
Active Comparator
Arm Description
Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine
Arm Title
MenACWY-CRM+PnC (12-15 months)
Arm Type
Experimental
Arm Description
Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC
Arm Title
MenACWY-CRM+DTaP (16-23 months)
Arm Type
Experimental
Arm Description
Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM Vaccine
Intervention Type
Biological
Intervention Name(s)
MenACWY-PS Vaccine
Primary Outcome Measure Information:
Title
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Description
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Time Frame
1 month post vaccination (Day 29)
Secondary Outcome Measure Information:
Title
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Description
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Time Frame
1 month post vaccination (Day 29)
Title
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Description
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
Time Frame
1 month post vaccination (Day 29)
Title
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Description
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
Time Frame
1 month post vaccination (Day 29)
Title
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Description
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
Time Frame
1 month post vaccination (Day 29)
Title
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Description
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
Time Frame
1 month post vaccination (Day 29)
Title
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Description
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Time Frame
12 months post vaccination (Day 360)
Title
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Description
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Time Frame
12 months post vaccination (Day 360)
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Description
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Time Frame
Day 1 to 7 post vaccination
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Description
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Time Frame
Day 1 to 7 post vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Description
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Time Frame
Day 1- Day 360 (throughout the study)
Title
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Description
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Time Frame
Day 1- Day 360 (Throughout the study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
10 Years
Eligibility Criteria
Inclusion Criteria:
Group 1: Healthy children 2-10 years of age;
Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.
Exclusion Criteria:
Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Permanente Vaccine Study Center
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
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