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

• ClinicalTrials.gov Identifier: NCT01410474
• Recruitment Status: Completed
• First Posted: August 5, 2011
• Results First Posted: September 22, 2014
• Last Update Posted: September 22, 2014
• Sponsor: Novartis
• Collaborator: Novartis Vaccines
• Information provided by (Responsible Party): Novartis

Tracking Information

• First Submitted Date: August 3, 2011
• First Posted Date: August 5, 2011
• Results First Submitted Date: March 12, 2013
• Results First Posted Date: September 22, 2014
• Last Update Posted Date: September 22, 2014
• Study Start Date: August 2011
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2014)

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:

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.

Original Primary Outcome Measures (submitted: August 4, 2011)

• 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 Measures (submitted: September 16, 2014)

• 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:

  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 ]
  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 Measures (submitted: August 4, 2011)

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 ]

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Bacterial Meningitis

Intervention

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.

Study Arms

Experimental: 2-18 years

Intervention: Biological: Meningococcal ACWY conjugate vaccine

• Publications *: Huang LM, Chiu NC, Yeh SJ, Bhusal C, Arora AK. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine. 2014 Sep 8;32(40):5177-84. doi: 10.1016/j.vaccine.2014.07.063. Epub 2014 Jul 27.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2012): 341
• Original Estimated Enrollment (submitted: August 4, 2011): 340
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01410474
• Other Study ID Numbers: V59_49
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novartis
• Study Sponsor: Novartis
• Collaborators: Novartis Vaccines

Investigators

• 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

• PRS Account: Novartis
• Verification Date: September 2014