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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00750360
First received: September 9, 2008
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Seasonal Influenza
 Biological: FluarixTM
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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 > 6 Months of Age at the Time of Vaccination.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants Reporting Severe Unsolicited Adverse Events [ Time Frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Number of Participant Reporting Unsolicited Adverse Events. [ Time Frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination ] [ Designated as safety issue: No ]
  • Number of Participants Reporting Serious Adverse Events (SAE). [ Time Frame: Within 1 month following vaccination ] [ Designated as safety issue: No ]

Enrollment: 883
Study Start Date: October 2003
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B
Subjects aged < 9 years who were previously not vaccinated against influenza
 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).
Experimental: Group A
Subjects aged ≥ 9 years and subjects 6 months to 9 years who have previously been vaccinated against influenza
 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).

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750360

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00750360     History of Changes
Other Study ID Numbers: 218352/054
Study First Received: September 9, 2008
Results First Received: December 23, 2008
Last Updated: April 8, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
Influenza
FluarixTM
Korea

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013