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 11, 2012
Last verified: September 2012

August 3, 2011
September 11, 2012
August 2011
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01410474 on ClinicalTrials.gov Archive Site
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.
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, Multi-center, 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 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 will have blood drawn at day 1 and day 29 and will receive a single dose of Meningococcal ACWY conjugate vaccine.
Experimental: Arm 1
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 are 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 2012

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