NCT00262028

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
910

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2016

Completed
Last Updated

February 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

December 2, 2005

Results QC Date

August 30, 2013

Last Update Submit

January 12, 2016

Conditions

Prevention of Meningococcal Disease

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (11)

  • 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

    1 month post vaccination (Day 29)

  • 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

    1 month post vaccination (Day 29)

  • hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

    1 month post vaccination (Day 29)

  • hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

    1 month post vaccination (Day 29)

  • 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

    1 month post vaccination (Day 29)

  • +6 more secondary outcomes

Study Arms (5)

MenACWY-CRM (2-10 years)

EXPERIMENTAL

Subjects received one dose of investigational MenACWY-CRM conjugate vaccine

Biological: MenACWY-CRM Vaccine

MenACWY-CRM (12-23 months)

EXPERIMENTAL

Subjects received one dose of investigational MenACWY-CRM conjugate vaccine

Biological: MenACWY-CRM Vaccine

MenACWY-PS (2-10 years)

ACTIVE COMPARATOR

Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine

Biological: MenACWY-PS Vaccine

MenACWY-CRM+PnC (12-15 months)

EXPERIMENTAL

Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC

Biological: MenACWY-CRM Vaccine

MenACWY-CRM+DTaP (16-23 months)

EXPERIMENTAL

Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP

Biological: MenACWY-CRM Vaccine

Interventions

MenACWY-CRM VaccineBIOLOGICAL
MenACWY-CRM (12-23 months)MenACWY-CRM (2-10 years)MenACWY-CRM+DTaP (16-23 months)MenACWY-CRM+PnC (12-15 months)
MenACWY-PS VaccineBIOLOGICAL
MenACWY-PS (2-10 years)

Eligibility Criteria

Age12 Months - 10 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

Location

MeSH Terms

Interventions

MenACWY-CRM vaccine

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Study Officials

  • Novartis Vaccines

    Novartis Vaccines & Diagnostics

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 6, 2005

Study Start

April 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 11, 2016

Results First Posted

February 11, 2016

Record last verified: 2016-01

Locations

US(1)