Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure
 requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety
 evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving
 MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
Inclusion Criteria:

 Individuals eligible for enrolment in this study are those:

 1. who are of any gender, from the age of 2 and older, and to whom/whose parents or
 legally acceptable representatives the nature of the study has been described and the
 subject/subject's parent/legally acceptable representative has provided written
 informed consent.

 2. who the investigator believes that the subject and/or his or her parent/legal
 representative can and will comply with the requirements of the protocol.

 3. who are in good health as determined by clinical judgment of the investigator.

 Exclusion Criteria:

 Individuals not eligible to be enrolled in the study are those:

 1. who are unwilling or unable to give written informed consent or assent to participate
 in the study.

 2. who are perceived to be unreliable or unavailable for the duration of the study
 period.

 3. who have previously been immunized with a meningococcal vaccine or vaccine containing
 meningococcal antigen(s) (licensed or investigational).

 4. who have received any investigational or non-registered product (drug or vaccine)
 within 30 days prior to enrolment or who expect to receive an investigational drug or
 vaccine prior to the completion of the study.

 5. who have received or who are planning to receive any vaccines (other than routine
 childhood vaccines) within 30 days before and after administration of study vaccine.

 (Exception: Influenza vaccine may be administered up to 15 days prior to study
 vaccination and at least 15 days after study vaccination)

 6. who have behavioral or cognitive impairment or psychiatric disease that, in the
 opinion of the investigator, may interfere with the subject's ability to participate
 in the study.

 7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to
 become pregnant during the course of the study.

 8. who have any serious acute, chronic or progressive disease (e.g., any history of
 neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or
 AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe
 malnutrition), who have epilepsy or any progressive neurological disease or history of
 Guillain-Barre syndrome.

 9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any
 vaccine components.

 10. who are known to have a bleeding diathesis, or any condition that may be associated
 with a prolonged bleeding time.

 11. who are included in study personnel or close family members of personnel conducting
 this study.