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

NCT ID: NCT00750360

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 883 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-03
• Study Completion Date: 2007-12-28

Brief 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).

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Unprimed, > 6 to < 72 Months

Subjects aged \> 6 months to \< 72 months who were previously not vaccinated against influenza (unprimed).

Group Type: EXPERIMENTAL

FluarixTM

Intervention Type: 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).

Unprimed, ≥ 72 to < 108 Months

Subjects aged ≥ 72 months to \< 108 months who were previously not vaccinated against influenza (unprimed).

Group Type: EXPERIMENTAL

FluarixTM

Intervention Type: 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).

Primed, > 6 to < 72 Months

Subjects aged \> 6 months to \< 72 months who previously received a vaccination against influenza (primed).

Group Type: EXPERIMENTAL

FluarixTM

Intervention Type: 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).

Primed, ≥ 72 to < 108 Months

Subjects aged ≥ 72 months to \< 108 months who previously received a vaccination against influenza (primed).

Group Type: EXPERIMENTAL

FluarixTM

Intervention Type: 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).

Primed, ≥ 108 to < 216 Months

Subjects aged ≥ 108 months to \< 216 months who previously received a vaccination against influenza (primed).

Group Type: EXPERIMENTAL

FluarixTM

Intervention Type: 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).

Primed, ≥ 216 Months

Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).

Group Type: EXPERIMENTAL

FluarixTM

Intervention Type: 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).

Interventions

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).

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

218352/054

Identifier Type: -

Identifier Source: org_study_id