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
  Purpose

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.


Condition Intervention Phase
Bacterial Meningitis
Biological: Meningococcal ACWY conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 341
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410474

Locations
China, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, China, 10002
Mackay Memorial Hospital,
Taipei, Taiwan, China, 10002
Far Eastern Memorial Hospital,
Taipei, Taiwan, China, 22060
Sponsors and Collaborators
Novartis
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
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01410474     History of Changes
Other Study ID Numbers: V59_49
Study First Received: August 3, 2011
Last Updated: September 11, 2012
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Novartis:
Meningococcal
ACWY
bacterial meningitis
conjugate vaccine
healthy
children
adolescents
Taiwan

Additional relevant MeSH terms:
Meningitis
Meningitis, Bacterial
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 15, 2014