Try our beta test site

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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00750360
First received: September 9, 2008
Last updated: November 3, 2016
Last verified: November 2016
  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
Influenza
Biological: FluarixTM
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 More Than 6 Months of Age at the Time of Vaccination

Resource links provided by NLM:


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 ]

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

  • 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.

  • 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.

  • 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.



Enrollment: 883
Study Start Date: October 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unprimed, > 6 to < 72 Months
Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
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: Unprimed, ≥ 72 to < 108 Months
Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
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: Primed, > 6 to < 72 Months
Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
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: Primed, ≥ 72 to < 108 Months
Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
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: Primed, ≥ 108 to < 216 Months
Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
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: Primed, ≥ 216 Months
Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750360

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

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 218352/054
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 218352/054
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 218352/054
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 218352/054
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 218352/054
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 218352/054
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
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: November 3, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Influenza
Korea
FluarixTM

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017