Clinical Trial: Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief Summary: 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.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: 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 ]
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:
- for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
- for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Original Primary Outcome:
- 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 ]
- 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 ]
Current Secondary Outcome:
- 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 ]
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:
- for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
- 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 ]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 ]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 ]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 ]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 ]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.
Original Secondary Outcome: 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 ]
Information By: Novartis
Dates:
Date Received: August 3, 2011
Date Started: August 2011
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014