A Phase 4 interventional study of Vaxigrip® in Influenza, sponsored by National University Hospital, Singapore. Completed at 9 sites in Singapore. Open to participants aged 21 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by National University Hospital, Singapore · Phase 4, Interventional, and Prevention
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Among 18 studies testing vaxigrip in Influenza, Human — 1 open to participants now, 2 under way, 1 of them phase 3. vaxigrip · Influenza, Human.
Among the 18 studies testing vaxigrip in Influenza, Human, this one is the 11th largest by enrollment, is one of 3 that started in 2013, is one of 8 in phase 4, and was the 15th registered.
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →1 of the 18 studies testing vaxigrip in Influenza, Human is open now, in 1 country. Recruiting first, the newest first:
University of Brawijaya · Sites in Indonesia
Ages 18–65
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.
This study: 21 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2013.
This study's enrollment of 240 is close to the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 277 across the 18 interventional studies. Of the 16 that completed or were terminated, 2 (13%) have results posted.
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5 of 18 have an industry lead sponsor. The 10 most frequent:
National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
National University Hospital, Singapore has 2 studies filed under Influenza, Human — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 18 studies testing vaxigrip in Influenza, Human, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy adult participants aged 21-40 years will be vaccinated with Vaxigrip® influenza vaccine
Drug: Vaxigrip®
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Drug: Vaxigrip®
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Drug: Vaxigrip®
Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.
Drug: Vaxigrip®
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.
The Immune Responsiveness of Elderly Subjects when Administered Influenza Vaccination as Measured by HAI
Hemagglutination Inhibition (HAI) titer
Time frame: 18-month period
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
Time frame: 18 months
Flu-Specific B Cell Response
No. of flu-specific B cells quantified out of 1x105 PBMCs
Time frame: 18 months
Inflammatory Markers
Quantitative (pg/mL analyte, picogram of analyte per milliliter of plasma)
Time frame: 18 months
Clinical Assessments of the elderly subjects - Weight
Quantitative Weight (kg, kilograms)
Time frame: 18 months
Clinical Assessments of the elderly subjects - Height
Quantitative Height (m, meters)
Time frame: 18 months
Clinical Assessments of the elderly subjects - BMI
Quantitative BMI (weight and height will be combined to report in kg/m2)
Time frame: 18 months
Clinical Assessments of the elderly subjects - DXA
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)
Time frame: 18 months
Plan to share: Yes — Publication of the data in peer-reviewed journals
Supporting information: Study protocol
Time frame: five years approx
Access criteria: through a research agreement
The record gives a start of Dec 2013, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vaxigrip
National University Hospital, Singapore →