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

Novartis

Status and phase: Completed; Phase 3

Conditions: Bacterial Meningitis

Treatments: Biological: Meningococcal ACWY conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410474

V59_49

Details and patient eligibility

About

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.

Enrollment: 341 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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341 participants in 1 patient group

2-18 years

Experimental group

Treatment:

Biological: Meningococcal ACWY conjugate vaccine