Phase 4
Completed N=249
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00290329 ↗
Enrolled (actual)
249
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events — 0; 0; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events |
0; 0; 0 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Adverse Events |
18; 10; 9; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
14; 9; 1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol.
- A Filipino male or female > 2 years of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parent/ guardian of the subject.
Exclusion criteria
- Subjects suffering from acute severe febrile illness.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Pregnant or lactating female.
- Female planning to become pregnant.
- History of chronic alcohol consumption and/or intravenous drug abuse.
- Any contraindications as stated on the Prescribing Information.
Data sourced from ClinicalTrials.gov (NCT00290329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.