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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.

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ClinicalTrials.gov Identifier: NCT01682876
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : October 6, 2014
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Meningococcal Disease Infections, Meningococcal Biological: MenACWY-CRM Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : October 7, 2012
Actual Primary Completion Date : July 2, 2013
Actual Study Completion Date : May 30, 2014


Arm Intervention/treatment
Placebo Comparator: 2 through 5 years (1 Vac) MenACWY-CRM 1
Subjects 2 through 5 years received one vaccination of MenACWY-CRM
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

Active Comparator: 2 through 5 years (2 Vac) MenACWY-CRM 2
Subjects 2 through 5 years received two vaccinations of MenACWY-CRM
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

Placebo Comparator: 6 through 10 years (1 Vac) MenACWY-CRM 3
Subjects 6 through 10 years received one vaccination of MenACWY-CRM
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

Active Comparator: 6 through 10 years (2 Vac) MenACWY-CRM 4
Subjects 6 through 10 years received two vaccinations of MenACWY-CRM
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




Primary Outcome Measures :
  1. 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 [ Time Frame: One Month After Last Vaccination ( day 86) ]
    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.

  2. 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 [ Time Frame: One Month After Last Vaccination (day 86) ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: One Month After Last Vaccination (day 86) ]
    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.

  2. 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 [ Time Frame: One Month After Last Vaccination (day 86) ]
    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.

  3. 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 [ Time Frame: One year after one vaccination or two vaccinations (day 422). ]
    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.

  4. 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 [ Time Frame: One year after one vaccination or two vaccinations (day 422). ]
    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.

  5. Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [ Time Frame: From Days 1-7 after each 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

  6. Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination [ Time Frame: From Days 1-7 after each 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

  7. Number of Subjects Who Reported Selected AEs After Any Vaccination [ Time Frame: Day 1 to Day 86 ]
    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

  8. Number of Subjects Who Reported Selected AEs After Any Vaccination [ Time Frame: Day 1 to Day 422 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682876


Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
United States, California
GSK Investigational Site
Sacramento, California, United States, 95822
United States, Florida
GSK Investigational Site
Lake Mary, Florida, United States, 32746
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30062
GSK Investigational Site
Woodstock, Georgia, United States, 30189
United States, Iowa
GSK Investigational Site
Council Bluffs, Iowa, United States, 51503
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40291
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Michigan
GSK Investigational Site
Niles, Michigan, United States, 49120
GSK Investigational Site
Stevensville, Michigan, United States, 49127
United States, Nebraska
GSK Investigational Site
Bellevue, Nebraska, United States, 68005
GSK Investigational Site
Fremont, Nebraska, United States, 68025
GSK Investigational Site
Omaha, Nebraska, United States, 68134
United States, New York
GSK Investigational Site
Johnson City, New York, United States, 13790
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44121
GSK Investigational Site
Cleveland, Ohio, United States, 44122
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Fort Worth, Texas, United States, 76135
United States, Utah
GSK Investigational Site
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01682876     History of Changes
Other Study ID Numbers: 205238
V59_57 ( Other Identifier: Novartis Vaccines )
2011-004421-27 ( EudraCT Number )
First Posted: September 11, 2012    Key Record Dates
Results First Posted: October 6, 2014
Last Update Posted: June 14, 2019
Last Verified: June 2019

Keywords provided by GlaxoSmithKline:
Prevention of meningococcal disease, children, vaccine

Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs