Clinical trial NCT00262028: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prevention of Meningococcal Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 910
Sex: ALL
Minimum age (years): 12
Maximum age (years): 10
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
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
timeFrame: 1 month post vaccination (Day 29)
Secondary outcomes:
measure: 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
timeFrame: 1 month post vaccination (Day 29)
measure: 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
timeFrame: 1 month post vaccination (Day 29)
measure: hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
timeFrame: 1 month post vaccination (Day 29)
measure: hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
timeFrame: 1 month post vaccination (Day 29)
measure: 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
timeFrame: 1 month post vaccination (Day 29)
measure: 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
timeFrame: 12 months post vaccination (Day 360)
measure: 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
timeFrame: 12 months post vaccination (Day 360)
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
timeFrame: Day 1 to 7 post vaccination
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
timeFrame: Day 1 to 7 post vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
timeFrame: Day 1- Day 360 (throughout the study)
measure: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
timeFrame: Day 1- Day 360 (Throughout the study)
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines
role: STUDY_CHAIR
References: