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Completed

NCT Number: NCT00750360

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

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).

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FluarixTM

Biological

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).

Primary outcomes

  1. Number of Participants Reporting Severe Unsolicited Adverse Events

    Time frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination

    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

Secondary outcomes

  1. Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.

    Time frame: During the 4-day follow up (Day 0 to 3) after vaccination.

    Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.

  2. Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.

    Time frame: During the 4-day follow up (Day 0 to 3) after vaccination.

    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.

  3. Number of Participant Reporting Unsolicited Adverse Events.

    Time frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination

    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.

  4. Number of Participants Reporting Serious Adverse Events (SAE).

    Time frame: Within 1 month following vaccination

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 10, 2008
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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