AzTrials
AzTrials

InfluenzaPhase 4NCT03266237

The Immune Response to Influenza Vaccinations in Elderly Individuals

A Phase 4 study testing Vaxigrip® in people with Influenza, run by National University Hospital, Singapore at 9 sites in Singapore.

Completed

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

Official record
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Trial summary

The aim of this study is to characterize the immune profile of frail and healthy aged individuals and investigate their immune responsiveness including the response to influenza vaccine over an 18-month period. Read more about this study

Who is it for?
Ages 21 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Vaxigrip®
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
9 sitesSingapore
Study dates
Dec 2013to May 2016
Phase
Phase 4
Are there results?
None posted in the registry

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 21 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 65 years and <90 years on the day of inclusion for the elderly group, and ≥ 21-<40 for the adult group.
  • Informed consent form has been signed and dated.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • Living at home.
  • Able to walk without personal assistance and no other physical limitations that can limit participation.
  • Recruited from the cohort in Singapore Longitudinal Ageing Study-II (SLAS-II), as well as from sites in West Jurong and from Outpatient clinics at National University Hospital (NUH).

Who cannot join

  • Participation at the time of study enrollment (or in the 4 weeks preceding trial vaccination) or planned participation during the present trial period in another clinical trial investigating vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination, including influenza vaccination. However, 23-valent pneumococcal vaccine and tetanus vaccine will be allowed during this time window.
  • Receipt of an influenza vaccine within the 6 months preceding the trial vaccination or planned influenza vaccination during the trial.
  • Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components or a history of a life-threatening reaction to Vaxigrip® or to a vaccine containing any of the same substances.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
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  • Current alcohol or drug addiction.
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
  • Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse) of the Investigator or employee with direct involvement in the proposed study.
  • Severe audio-visual impairment.
  • Dementia, severe cognitive impairment (MMSE <18), major depression or other psychotic disorders.
  • Progressive, degenerative neurologic disease: e.g. Alzheimer's disease.
  • Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months.
  • Primary severely muscle/joint disorders resulting in physical disability interfering with the physical performance tests needed for the study.
  • Hospital admission in the past 6 weeks.
  • (Relevant for the healthy young adults subjects group). Subject is pregnant (or positive urine pregnancy test), or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding vaccination, contraindicating intramuscular vaccination upon investigator's judgement.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Singapore9 sites

  • Moral Neighbourhood Link @ Telok Blangah

    Singapore, 090003

  • National University Hospital

    Singapore, 119228

  • THK Seniors Activity Centre @ Henderson (Satellite 93)

    Singapore, 150093

  • Moral Neighbourhood Link (Bukit Merah View)

    Singapore, 150118

  • THK Seniors Activity Centre @ Beo Crescent

    Singapore, 160044

  • SARAH Senior Activity Centre

    Singapore, 160105

  • THK Seniors Service @ Taman Jurong

    Singapore, 610337

  • TaRa @ Jurong Point, Jurong West Central 2

    Singapore, 648886

  • Outpatient Clinic, St Luke's Hospital

    Singapore, 659674

Other trials in Singapore

About this study

Official title: Multi-parameter Immune Profile Associated With the Humoral Response to Influenza Vaccine, Vaxigrip® in Healthy and Frail Elderly Subjects Aged 65-90 Years in Singapore

The aim of this study is to characterize the immune profile of frail and healthy aged individuals and investigate their immune responsiveness including the response to influenza vaccine over an 18-month period. The project will include a longitudinal study to define immune signatures and multi-parameter profiles associated with frailty and may lead to the identification of predictive markers of evolution to frailty and Immunosenescence in the elderly.

Read the detailed description

With better healthcare available and improved accessibility, people are living longer. However, a majority of older persons cannot be considered to be aging well. Approximately 70% of those aged 85 years or older require frequent long hospitalizations because of their increased susceptibility to infections, cancers, dementia, and other age-related health problems, along with overall loss of function and autonomy associated with old age. Previous studies have shown that vaccination against influenza, which significantly reduces all-cause mortality in the elderly (65 years and older), was less immunogenic and effective with age. Frailty, a geriatric syndrome associated with low functional activity, weight loss, exhaustion, disability, decreased resilience to stressors, has been shown to increase risk for adverse outcomes and death. Better understanding the relationship between aging and waning immune responsiveness will enable the development of strategies to improve response to vaccination in the elderly and reduce morbidity and eventually mortality associated with age related complications and outcomes such as infectious diseases or frailty. A comprehensive analysis of the immune phenotype and function after antigenic challenge in older individuals would be a unique approach to understand (i) the potential associations between aging, impaired immune function and transition to frailty, (ii) which components of the immune system are altered with aging (innate vs adaptive immunity) and (iii) if early and/or late immune responses are preferentially altered with aging and frailty.

Conditions
Influenza
Being tested
Vaxigrip®
Keywords
Influenza, Influenza Virus Vaccines, Vaxigrip, Respiratory Tract Infections, Orthomyxoviridae Infections, Frailty, Aging, Safety, Immunogenicity
Medical subject headings
Influenza, Human, Respiratory Tract Infections, Orthomyxoviridae Infections, Frailty

What participants receive

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

  • Vaxigrip®Drug

    To describe the humoral immune response to Vaxigrip (IM) vaccination at Day 0 (baseline) and Day 28 according to the age and frailty status at baseline (i.e. in each study group) for each Influenza strain.

Study groups in NCT03266237
Study groupRoleWhat they receive
Healthy AdultExperimentalHealthy adult participants aged 21-40 years will be vaccinated with Vaxigrip® influenza vaccine
Receives: Drug: Vaxigrip®
Healthy ElderlyExperimentalHealthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Receives: Drug: Vaxigrip®
Healthy Elderly Pre-FrailExperimentalHealthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Receives: Drug: Vaxigrip®
Healthy Elderly FrailExperimentalHealthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Receives: Drug: Vaxigrip®

What is being measured

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

  1. The Immune Responsiveness of Elderly Subjects when Administered Influenza Vaccination as Measured by HAI

    Hemagglutination Inhibition (HAI) titer

    Measured: 18-month period

Secondary outcomes (3)

  1. Cellular Immune Response and Inflammatory Profile of elderly subjects when administered influenza vaccination - Flu-Specific T cells

    % Flu-specific T cells out of total PBMCs

    Measured: 18 months

  2. Flu-Specific B Cell Response

    No. of flu-specific B cells quantified out of 1x105 PBMCs

    Measured: 18 months

  3. Inflammatory Markers

    Quantitative (pg/mL analyte, picogram of analyte per milliliter of plasma)

    Measured: 18 months

Timeline

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

  1. First posted30 Aug 2017
  2. Study startDec 2013
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266237
Sponsor's protocol ID
2012/01214
Status last verified
Oct 2016
First submitted
20 Sep 2016
Last updated
30 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Publication of the data in peer-reviewed journals

Publications

  • Camous X, Visan L, Ying CTT, Abel B, Nyunt MSZ, Narang V, Poidinger M, Carre C, Sesay S, Bosco N, Burdin N, Tambyah PA, Pin NT, Larbi A. Healthy elderly Singaporeans show no age-related humoral hyporesponsiveness nor diminished plasmablast generation in response to influenza vaccine. Immun Ageing. 2018 Nov 12;15:28. doi: 10.1186/s12979-018-0137-4. eCollection 2018.

    PubMed 30455722

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vaxigrip® in people with Influenza, run by National University Hospital, Singapore at 9 sites in Singapore.

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 6 inclusion and 18 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The Immune Responsiveness of Elderly Subjects when Administered Influenza Vaccination as Measured by HAI (time frame: 18-month period). 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 NCT03266237, which also lists 1 linked publication.

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 30 Aug 2017.

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