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

Prevention of Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262028
• Other study ID #: V59P8
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2005
• Last updated: January 12, 2016
• Start date: April 2005
• Est. completion date: November 2006

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 910
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Gender: Both
• Age group: 12 Months to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infections
• Prevention of Meningococcal Disease

Intervention

Biological:
• MenACWY-CRM Vaccine

• MenACWY-PS Vaccine

Locations

Country	Name	City	State
United States	Kaiser Permanente Vaccine Study Center	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post vaccination (Day 29)	No
Secondary	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.	1 month post vaccination (Day 29)	No
Secondary	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.	1 month post vaccination (Day 29)	No
Secondary	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.	1 month post vaccination (Day 29)	No
Secondary	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.	1 month post vaccination (Day 29)	No
Secondary	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.	1 month post vaccination (Day 29)	No
Secondary	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.	12 months post vaccination (Day 360)	No
Secondary	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.	12 months post vaccination (Day 360)	No
Secondary	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.	Day 1 to 7 post vaccination	Yes
Secondary	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.	Day 1 to 7 post vaccination	Yes
Secondary	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.	Day 1- Day 360 (throughout the study)	Yes
Secondary	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.	Day 1- Day 360 (Throughout the study)	Yes