Phase 4
Completed N=875
Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
Source: ClinicalTrials.gov NCT00750360 ↗Enrolled (actual)
875
Serious AEs
0.1%
Results posted
Jun 2009
Primary outcomePrimary: Number of Participants Reporting Severe Unsolicited Adverse Events — 0; 0; 0; 0 participants
Summary
The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Severe Unsolicited Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months. |
3; 22; 3; 58; 3; 40 | — |
| SECONDARY Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older. |
0; 23; 7; 10; 0; 11 | — |
| SECONDARY Number of Participant Reporting Unsolicited Adverse Events. |
28; 0; 67; 12; 6; 3 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAE). |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female > 6 months of age at the time of the first vaccination.
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
Exclusion Criteria
- Clinical signs of acute febrile illness at the time of entry into the study.
- Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.
Data sourced from ClinicalTrials.gov (NCT00750360). 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.