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

Bacterial Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410474
• Other study ID #: V59_49
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2011
• Last updated: September 16, 2014
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Meningitis
• Meningitis
• Meningitis, Bacterial

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.

Locations

Country	Name	City	State
China	Far Eastern Memorial Hospital,	Taipei	Taiwan
China	Mackay Memorial Hospital,	Taipei	Taiwan
China	National Taiwan University Hospital	Taipei	Taiwan

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination	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.	Day 1 and Day 29	No
Secondary	Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group	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.	Day 1 and Day 29	No
Secondary	Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination	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.	Day 1 and 29	No
Secondary	Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination	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.	Day 1 and Day 29	No
Secondary	Percentage of Subjects With hSBA Titer =1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination	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.	Day 1 and 29	No
Secondary	Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years	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.	From day 1 through day 7 postvaccination	Yes
Secondary	Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years	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.	From day 1 through day 7 postvaccination	Yes