Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.

Influenza Clinical Trial

Official title:

Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750360
• Other study ID #: 218352/054
• Status: Completed
• Phase: Phase 4
• Start date: October 3, 2003
• Est. completion date: December 28, 2007

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 883
• Est. completion date: December 28, 2007
• Est. primary completion date: December 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• FluarixTM
All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Severe Unsolicited Adverse Events	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.; Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities	During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Secondary	Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.	Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.	During the 4-day follow up (Day 0 to 3) after vaccination.
Secondary	Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.	Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.	During the 4-day follow up (Day 0 to 3) after vaccination.
Secondary	Number of Participant Reporting Unsolicited Adverse Events.	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Secondary	Number of Participants Reporting Serious Adverse Events (SAE).	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	Within 1 month following vaccination

External Links

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