Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01410474
First received: August 3, 2011
Last updated: September 16, 2014
Last verified: September 2014

August 3, 2011
September 16, 2014
August 2011
January 2012   (final data collection date for primary outcome measure)
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]

Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).

Seroresponse is defined as:

  1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
  2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
  • To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y. [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
  • To assess the safety profile following MenACWY-CRM vaccination in terms of percentage and number of subjects with: • Local and systemic reactions • All other adverse events (AEs) • Serious Adverse Events (SAEs) and Medically attended AEs [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01410474 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.

    Seroresponse is defined as:

    1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
    2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
  • Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination [ Time Frame: Day 1 and 29 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
  • Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
  • Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination [ Time Frame: Day 1 and 29 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.
  • Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years [ Time Frame: From day 1 through day 7 postvaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.
  • Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years [ Time Frame: From day 1 through day 7 postvaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y by age group (2-10, 11-18 years). [ Time Frame: 29 days ] [ Designated as safety issue: No ]
• To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA geometric mean titers (GMTs and GMR) and by the percentage of subjects with hSBA titer ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y, overall and by age group.
Not Provided
Not Provided
 
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
A Phase 3, Multicenter, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 18 Years in Taiwan

This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Bacterial Meningitis
Biological: Meningococcal ACWY conjugate vaccine
All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.
Experimental: 2-18 years
Intervention: Biological: Meningococcal ACWY conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
341
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy subjects from 2 up to and including 18 years of age
  2. Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age

Exclusion Criteria:

Individuals not eligible to be enrolled in the study were those:

  1. Who had a previous confirmed or suspected disease caused by N. meningitidis.
  2. Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrolment.
  3. Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
  4. Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines.
  5. Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.
  6. Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
  7. Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
  8. Who have a known or suspected impairment/alteration of immune function, either congenital or acquired
  9. Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  10. Who have Down's syndrome or other known cytogenic disorders.
Both
2 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01410474
V59_49
Not Provided
Novartis
Novartis
Novartis Vaccines
Principal Investigator: Li Min Huang, Dr. Dr. Li Min Huang, National Taiwan University Hospital
Principal Investigator: Nan Chang Chiu, Dr. Mackay Memorial Hospital
Principal Investigator: Shu Jen Yeh, Dr. Far Eastern Memorial Hospital
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP