Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00262028
First received: December 2, 2005
Last updated: January 12, 2016
Last verified: January 2016

December 2, 2005
January 12, 2016
April 2005
November 2006   (final data collection date for primary outcome measure)
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 [ Time Frame: 1 month post vaccination (Day 29) ] [ Designated as safety issue: No ]
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.
To compare the immunogenicity of a single dose of Chiron MenACWY Conjugate Vaccine with the immunogenicity of a single dose of licensed meningococcal ACWY polysaccharide vaccine (Menomune®), defined as percentage of subjects with serum bactericidal activ
Complete list of historical versions of study NCT00262028 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 1 month post vaccination (Day 29) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination (Day 29) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination (Day 29) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination (Day 29) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post vaccination (Day 29) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post vaccination (Day 360) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post vaccination (Day 360) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 to 7 post vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 to 7 post vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1- Day 360 (throughout the study) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1- Day 360 (Throughout the study) ] [ Designated as safety issue: Yes ]
    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.
To assess the safety and tolerability of a single dose of either the adjuvanted or unadjuvanted formulation of Chiron MenACWY Conjugate Vaccine compared to the safety and tolerability of a single dose of Menomune®
Not Provided
Not Provided
 
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Prevention of Meningococcal Disease
  • Biological: MenACWY-CRM Vaccine
  • Biological: MenACWY-PS Vaccine
  • Experimental: MenACWY-CRM (2-10 years)
    Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
    Intervention: Biological: MenACWY-CRM Vaccine
  • Experimental: MenACWY-CRM (12-23 months)
    Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
    Intervention: Biological: MenACWY-CRM Vaccine
  • Active Comparator: MenACWY-PS (2-10 years)
    Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine
    Intervention: Biological: MenACWY-PS Vaccine
  • Experimental: MenACWY-CRM+PnC (12-15 months)
    Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC
    Intervention: Biological: MenACWY-CRM Vaccine
  • Experimental: MenACWY-CRM+DTaP (16-23 months)
    Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP
    Intervention: Biological: MenACWY-CRM Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
910
November 2006
November 2006   (final data collection date for primary outcome measure)

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.
Both
12 Months to 10 Years   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262028
V59P8
No
Not Provided
Not Provided
Novartis Vaccines
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines & Diagnostics
Novartis
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP