Trial · NCT00377611

Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™

NCT00377611, Phase 4, Completed, GlaxoSmithKline; results first posted 2018-10-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™. Trials, record NCT00377611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377611

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™
NCT number: NCT00377611
Status: Completed
Phases: Phase 4
Enrollment: 3,054 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Influenza
Interventions: Fluarix™
First posted: 2006-09-18
Last updated: 2018-10-09
Results first posted: 2018-10-09
Limitations and caveats: None reported.

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	From Month 0 to Month 6	Analysis included all non-confirmed or lab confirmed ILI episodes (at least 1 episode, 1 episode, 2 episodes or more than (\>) 2 episodes) reported.
Primary	Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	From Month 0 to Month 6	Lab confirmed ILI episodes were assessed by means of viral culture (VC) infection (nasal and throat swabs) determination and/or using the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay.
Primary	Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	From Month 0 to Month 6	ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.
Primary	Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	From Month 0 to Month 6	Laboratory confirmed (LC) ILI which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1), as part of the ILI surveillance.
Primary	Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	From Month 0 to Month 6	As part of ILI surveillance any reasons, or other reasons than those mentioned which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1).
Primary	Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	From Month 0 to Month 6	ILI complications which led to subject hospitalization, emergency room visits and unplanned medical office visits were recorded by number (at least 1, 1, or above 1) as part of the ILI surveillance, which included: pneumonia, ischemic heart disease, congestive failure, acute cerebrovascular disease chronic obstructive pulmonary disease (COPD) exacerbation.
Primary	Number of Subjects With Influenza-related Complications	From Month 0 to Month 6	ILI complications refer to episodes of pneumonia, ischemic heart disease \[HD\] (unstable angina or myocardial infarction), congestive heart failure \[HF\], acute cerebrovascular disease \[ACD\] (stroke or transient ischemic attack \[IA\]), COPD exacerbation and all illnesses (pooled episode of each illness). ILI complications were recorded by number of episodes (at least 1 episode, 1 episode and above 1 episode).
Primary	Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	From Month 0 to Month 6	Death due to lab confirmed influenza infection was recorded during the influeza period only.
Primary	Number of Subjects With Fatal Outcomes	From Month 0 to Month 6	Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza
Primary	Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	From Month 0 to Month 6	RSV infection was determined by the RT-PCR assay.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Influenza-related Complications	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Fatal Outcomes	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)	From Month 0 to Month 6	The analysis was performed on the Total Vaccinated Cohort which included all subjects with one vaccine administration documented, for whom data were available.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group282

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50-64 Years Group	At least 1 ILI episode	133	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 65+ Years Group	At least 1 ILI episode	243	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50+ Years Group	At least 1 ILI episode	376	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50-64 Years Group	1 ILI episode	125	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 65+ Years Group	1 ILI episode	231	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50+ Years Group	1 ILI episode	356	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50-64 Years Group	2 ILI episodes	8	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 65+ Years Group	2 ILI episodes	12	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50+ Years Group	2 ILI episodes	20	Participants
Number of Subjects With at Least One Influenza-like-infection (ILI) Episode	Fluarix 50-64 Years Group	>2 ILI episodes	0	Participants

1 to 10 of 282Source ClinicalTrials.gov

See all 282 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fluarix 50-64 Years Group	1,047
Overall Study	STARTED	Fluarix 65+ Years Group	2,007
Overall Study	COMPLETED	Fluarix 50-64 Years Group	1,025
Overall Study	COMPLETED	Fluarix 65+ Years Group	1,974
Overall Study	NOT COMPLETED	Fluarix 50-64 Years Group	22
Overall Study	NOT COMPLETED	Fluarix 65+ Years Group	33

Source ClinicalTrials.gov

Adverse events234

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Myocardial infarction	Cardiac disorders	Fluarix 50-64 Years Group	2	1,047
serious	Myocardial infarction	Cardiac disorders	Fluarix 65+ Years Group	4	2,007
serious	Angina pectoris	Cardiac disorders	Fluarix 50-64 Years Group	0	1,047
serious	Angina pectoris	Cardiac disorders	Fluarix 65+ Years Group	5	2,007
serious	Pneumonia	Infections and infestations	Fluarix 50-64 Years Group	0	1,047
serious	Pneumonia	Infections and infestations	Fluarix 65+ Years Group	5	2,007
serious	Atrial fibrillation	Cardiac disorders	Fluarix 50-64 Years Group	0	1,047
serious	Atrial fibrillation	Cardiac disorders	Fluarix 65+ Years Group	4	2,007
serious	Coronary artery disease	Cardiac disorders	Fluarix 50-64 Years Group	0	1,047
serious	Coronary artery disease	Cardiac disorders	Fluarix 65+ Years Group	4	2,007

1 to 10 of 234Source ClinicalTrials.gov

See all 234 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fluarix 50-64 Years Group	2	1,047
Total, all-cause mortality	Fluarix 65+ Years Group	10	2,007
Total, other adverse events	Fluarix 50-64 Years Group	0	0
Total, other adverse events	Fluarix 65+ Years Group	0	0
Total, serious adverse events	Fluarix 50-64 Years Group	23	1,047
Total, serious adverse events	Fluarix 65+ Years Group	105	2,007

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fluarix 50-64 Years Group vs Fluarix 65+ Years Group: deaths from any cause	Trial comparisons
Fluarix 50-64 Years Group vs Fluarix 65+ Years Group: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00377611

GET https://conductscience.org/api/trials/v1/NCT00377611/results?page=2

API reference For AI assistants