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

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Study to Investigate the Incidence of Influenza and Influenza-related Complications, in Adults Between 50-64 Years and Elderly Adults 65 Years and Over Vaccinated With Fluarix™

ClinicalTrials.gov ID

NCT00377611

Acronym / sponsor ID

107564

Conditions

Influenza

Keywords

Influenza vaccine

Phase

Phase 4

Study type

Interventional

Recruitment status

Completed

Enrolment

3,054 participants (actual)

Lead sponsor

GlaxoSmithKlineIndustry (pharma, biotech, devices)

Study start

5 Oct 2006 (actual)

Primary completion

20 Jun 2007 (actual)

Study completion

20 Jun 2007 (actual)

First posted

18 Sep 2006 (estimated)

Results

Posted 9 Oct 2018

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

Single group

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

50 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

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

Interventions

Primary outcome

1. Number of Subjects With at Least One Influenza-like-infection (ILI) Episode

   Time frame: 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.

2. Number of Subjects With Laboratory-confirmed Influenza Infection Type A and/or Type B

   Time frame: 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.

3. Number of Subjects With Hospitalization, Emergency Room Visits, or Unscheduled Medical Office Visits Due to ILI

   Time frame: 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.

4. Number of Subjects With Hospitalizations, Emergency Room Visits or Unscheduled Medical Office Visits, Due to Laboratory Confirmed Influenza

   Time frame: 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.

5. Number of Subjects With Hospitalization or Emergency Room Visit for Any Cause

   Time frame: 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).

6. Number of Subjects With Emergency Room Visits, or Unscheduled Medical Office Visits Due to Influenza-related Complications

   Time frame: 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.

7. Number of Subjects With Influenza-related Complications

   Time frame: 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).

8. Number of Subjects With Fatal Outcomes Due to Laboratory Confirmed Influenza Infection

   Time frame: From Month 0 to Month 6

   Death due to lab confirmed influenza infection was recorded during the influeza period only.

9. Number of Subjects With Fatal Outcomes

   Time frame: From Month 0 to Month 6

   Number of deaths caused by laboratory non-confirmed ILI or other reasons were recorded during the influenza

10. Number of Subjects With Laboratory-confirmed Respiratory Syncytial Virus Infection (RSV)

    Time frame: From Month 0 to Month 6

    RSV infection was determined by the RT-PCR assay.

11. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: From Month 0 to Month 6

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

12. Number of Seroconverted Subjects for Each Influenza Strain

    Time frame: At Day 21

    A seroconverted subject was defined as a subject having either a pre-vaccination hemagglutinin inhibition (HI) titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥1:10 and a minimum four-fold increase in the post-vaccination titer. Assessed influenza strains were A/New Caledonia, A/Wisconsin and B/Malaysia.

13. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease

    Time frame: At Day 21

    The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titer (GMT) post vaccination on Day 21 compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.

14. Number of Seroprotected Subjects Against the 3 Influenza Strains

    Time frame: At Day 0 (PRE)

    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.

15. Number of Seroprotected Subjects Against the 3 Influenza Strains

    Time frame: At Day 21

    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥1:40.

16. Number of Seropositive Subjects for Each Influenza Strain

    Time frame: At Day 0 (PRE)

    A seropositive subject was defined as a vaccinated subject with antibody titer ≥1:10.

17. Number of Seropositive Subjects for Each Influenza Strain

    Time frame: At Day 21

    A seropositive subject was defined as a vaccinated subject with an antibody titer ≥1:10.

18. Serum HI Antibody Titers for Each Influenza Strain

    Time frame: At Day 0 (PRE)

    Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

19. Serum HI Antibody Titers for Each Influenza Strain

    Time frame: At Day 21

    Serum HI antibody titers were expressed as Geometric Mean Titers (GMTs).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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.

37 sites in 4 countries: see every site and its status.