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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM | 2 years of age and older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novartis Meningococcal ACWY Conjugate Vaccine | Biological | Immunization |
|
| Measure | Description | Time Frame |
|---|---|---|
| All adverse events | Day 29 | |
| All serious adverse events | Day 29 |
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Inclusion Criteria:
Individuals eligible for enrolment in this study are those:
Exclusion Criteria:
Individuals not eligible to be enrolled in the study are those:
who are unwilling or unable to give written informed consent or assent to participate in the study.
who are perceived to be unreliable or unavailable for the duration of the study period.
who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
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.
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)
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.
who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study.
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.
who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
who are included in study personnel or close family members of personnel conducting this study.
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Healthy male and female subjects 2 years of age and older
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| D007239 | Infections |