Status:
COMPLETED
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Bacterial Meningitis
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Healthy subjects from 2 up to and including 18 years of age
- 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
- Individuals not eligible to be enrolled in the study were those:
- Who had a previous confirmed or suspected disease caused by N. meningitidis.
- Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrolment.
- Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
- 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.
- Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.
- Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
- Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
- Who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Who have Down's syndrome or other known cytogenic disorders.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT01410474
Start Date
August 1 2011
End Date
January 1 2012
Last Update
September 22 2014
Active Locations (3)
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1
Mackay Memorial Hospital,
Taipei, Taiwan, China, 10002
2
National Taiwan University Hospital
Taipei, Taiwan, China, 10002
3
Far Eastern Memorial Hospital,
Taipei, Taiwan, China, 22060