InfluenzaPhase 4NCT00750360

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

A Phase 4 study testing FluarixTM in people with Influenza, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: FluarixTM
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 883 participants
Where: No sites listed yet
Study dates: 3 Oct 2003to 28 Dec 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

Conditions: Influenza
Being tested: FluarixTM
Keywords: Influenza, Korea, FluarixTM
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluarixTMBiological
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).

Study groups in NCT00750360
Study group	Role	What they receive
Unprimed, > 6 to < 72 Months	Experimental	Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed). Receives: Biological: FluarixTM
Unprimed, ≥ 72 to < 108 Months	Experimental	Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed). Receives: Biological: FluarixTM
Primed, > 6 to < 72 Months	Experimental	Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed). Receives: Biological: FluarixTM
Primed, ≥ 72 to < 108 Months	Experimental	Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed). Receives: Biological: FluarixTM
Primed, ≥ 108 to < 216 Months	Experimental	Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed). Receives: Biological: FluarixTM
Primed, ≥ 216 Months	Experimental	Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed). Receives: Biological: FluarixTM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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.
Measured: During the 4-day follow up (Day 0 to 3) after vaccination.
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.
Measured: During the 4-day follow up (Day 0 to 3) after vaccination.
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.
Measured: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
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.
Measured: Within 1 month following vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 200328 Dec 2007

First posted10 Sep 2008 (estimated)
Study start3 Oct 2003
Primary completion1 Dec 2007
Study completion28 Dec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 883 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00750360
Sponsor's protocol ID: 218352/054
Status last verified: Nov 2016
First submitted: 9 Sep 2008
Last updated: 6 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00750360
Acronym / sponsor ID: 218352/054
Conditions: Influenza
Keywords: Influenza, Korea, FluarixTM
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 883 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Oct 2003
Primary completion: 1 Dec 2007 (actual)
Study completion: 28 Dec 2007 (actual)
First posted: 10 Sep 2008 (estimated)
Results: Posted 2 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Unprimed, > 6 to < 72 Months	Experimental	Biological: FluarixTMSubjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
Unprimed, ≥ 72 to < 108 Months	Experimental	Biological: FluarixTMSubjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
Primed, > 6 to < 72 Months	Experimental	Biological: FluarixTMSubjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
Primed, ≥ 72 to < 108 Months	Experimental	Biological: FluarixTMSubjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
Primed, ≥ 108 to < 216 Months	Experimental	Biological: FluarixTMSubjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
Primed, ≥ 216 Months	Experimental	Biological: FluarixTMSubjects aged ≥ 216 months who previously received a vaccination against influenza (primed).

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluarixTMAll 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).	Biological	Primed, > 6 to < 72 Months, Primed, ≥ 108 to < 216 Months, Primed, ≥ 216 Months, Primed, ≥ 72 to < 108 Months, Unprimed, > 6 to < 72 Months, Unprimed, ≥ 72 to < 108 Months

Primary outcome

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

4 secondary outcomes

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.
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.
Number of Participant Reporting Unsolicited Adverse Events.
Time frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Number of Participants Reporting Serious Adverse Events (SAE).
Time frame: Within 1 month following vaccination

Results and safety

Results posted to the registry on 2 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unprimed, > 6 to < 72 Months	294	294
Unprimed, ≥ 72 to < 108 Months	1	1
Primed, > 6 to < 72 Months	384	384
Primed, ≥ 72 to < 108 Months	79	79
Primed, ≥ 108 to < 216 Months	46	46
Primed, ≥ 216 Months	71	71

Primary outcome: Number of Participants Reporting Severe Unsolicited Adverse Events

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

Measure	Unprimed, > 6 to < 72 Months n = 294	Unprimed, ≥ 72 to < 108 Months n = 1	Primed, > 6 to < 72 Months n = 384	Primed, ≥ 72 to < 108 Months n = 79	Primed, ≥ 108 to < 216 Months n = 46	Primed, ≥ 216 Months n = 71
Value	0	0	0	0	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unprimed, > 6 to < 72 Months	1 of 294 (0.3%)	9 of 294 (3.1%)	Not reported
Unprimed, ≥ 72 to < 108 Months	0 of 1 (0%)	0 of 1 (0%)	Not reported
Primed, > 6 to < 72 Months	0 of 384 (0%)	90 of 384 (23.4%)	Not reported
Primed, ≥ 72 to < 108 Months	0 of 79 (0%)	27 of 79 (34.2%)	Not reported
Primed, ≥ 108 to < 216 Months	0 of 46 (0%)	10 of 46 (21.7%)	Not reported
Primed, ≥ 216 Months	0 of 71 (0%)	11 of 71 (15.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FluarixTM in people with Influenza, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Severe Unsolicited Adverse Events (time frame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00750360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.