The Immune Response to Influenza Vaccinations in Elderly Individuals
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Singapore, Singapore, 119228
- National University Hospital
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Singapore, Singapore, 090003
- Moral Neighbourhood Link @ Telok Blangah
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Singapore, Singapore, 150093
- THK Seniors Activity Centre @ Henderson (Satellite 93)
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Singapore, Singapore, 150118
- Moral Neighbourhood Link (Bukit Merah View)
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Singapore, Singapore, 160044
- THK Seniors Activity Centre @ Beo Crescent
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Singapore, Singapore, 160105
- SARAH Senior Activity Centre
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Singapore, Singapore, 610337
- THK Seniors Service @ Taman Jurong
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Singapore, Singapore, 648886
- TaRa @ Jurong Point, Jurong West Central 2
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Singapore, Singapore, 659674
- Outpatient Clinic, St Luke's Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Healthy Adult
Healthy adult participants aged 21-40 years will be vaccinated with Vaxigrip® influenza vaccine
|
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.
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EXPERIMENTAL: Healthy Elderly
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
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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.
|
|
EXPERIMENTAL: Healthy Elderly Pre-Frail
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
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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.
|
|
EXPERIMENTAL: Healthy Elderly Frail
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Immune Responsiveness of Elderly Subjects when Administered Influenza Vaccination as Measured by HAI
Time Frame: 18-month period
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Hemagglutination Inhibition (HAI) titer
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18-month period
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cellular Immune Response and Inflammatory Profile of elderly subjects when administered influenza vaccination - Flu-Specific T cells
Time Frame: 18 months
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% Flu-specific T cells out of total PBMCs
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18 months
|
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Flu-Specific B Cell Response
Time Frame: 18 months
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No. of flu-specific B cells quantified out of 1x105 PBMCs
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18 months
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Inflammatory Markers
Time Frame: 18 months
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Quantitative (pg/mL analyte, picogram of analyte per milliliter of plasma)
|
18 months
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Assessments of the elderly subjects - Weight
Time Frame: 18 months
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Quantitative Weight (kg, kilograms)
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18 months
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Clinical Assessments of the elderly subjects - Height
Time Frame: 18 months
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Quantitative Height (m, meters)
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18 months
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Clinical Assessments of the elderly subjects - BMI
Time Frame: 18 months
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Quantitative BMI (weight and height will be combined to report in kg/m2)
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18 months
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Clinical Assessments of the elderly subjects - DXA
Time Frame: 18 months
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Quantitative Dual-Energy X-Ray Absorptiometry (DXA) scan: Standardized Muscle Index (appendicular lean mass / height-squared); T-score based on Bone Mineral Density BMD (appendicular lean mass and height will be combined to report in g/cm2)
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18 months
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Professor Paul Anantharajah Tambyah, MD, National University, Singapore
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2012/01214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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