Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

Infections, Meningococcal Clinical Trial

Official title:

A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682876
• Other study ID #: 205238
• Secondary ID: V59_572011-00442
• Status: Completed
• Phase: Phase 3
• Start date: October 7, 2012
• Est. completion date: May 30, 2014

Study information

• Verified date: June 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: May 30, 2014
• Est. primary completion date: July 2, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria:

• Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

Exclusion Criteria:

1. Unwilling or unable to give written informed assent or consent to participate in the study.

2. Perceived to be unreliable or unavailable for the duration of the study period.

3. Previous confirmed or suspected disease caused by N. meningitidis.

4. Previously immunized with a meningococcal vaccine (licensed or investigational).

5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.

6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.

(certain exceptions influenza vaccines apply)

7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.

8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.

9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components

10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

• receipt of immunosuppressive therapy,

• receipt of immunostimulants,

• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.

11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• MenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bellevue	Nebraska
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Council Bluffs	Iowa
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fremont	Nebraska
United States	GSK Investigational Site	Johnson City	New York
United States	GSK Investigational Site	Lake Mary	Florida
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Niles	Michigan
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Stevensville	Michigan
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination	Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer =1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA =1:4, an increase of at least four times of the prevaccination hSBA titer.	One Month After Last Vaccination ( day 86)
Primary	Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination	Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer =1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA =1:4, an increase of at least four times of the prevaccination hSBA titer.	One Month After Last Vaccination (day 86)
Secondary	Percentage of Subjects With hSBA Titer =1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM	Immunogenicity was measured as the percentage of subjects who achieved hSBA titer =1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.	One Month After Last Vaccination (day 86)
Secondary	Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM	Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.	One Month After Last Vaccination (day 86)
Secondary	Percentage of Subjects With hSBA Titer =1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM	Immunogenicity was measured as the percentage of subjects with hSBA titer =1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.	One year after one vaccination or two vaccinations (day 422).
Secondary	Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM	Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.	One year after one vaccination or two vaccinations (day 422).
Secondary	Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination	Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM	From Days 1-7 after each vaccination
Secondary	Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination	Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM	From Days 1-7 after each vaccination
Secondary	Number of Subjects Who Reported Selected AEs After Any Vaccination	Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM	Day 1 to Day 86
Secondary	Number of Subjects Who Reported Selected AEs After Any Vaccination	Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM	Day 1 to Day 422