Chronic IllnessNCT01508884
Intradermal Trivalent Influenza Vaccine With Imiquimod
A study testing influenza vaccine, Imiquimod and Aqueous cream in people with Chronic Illness, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Despite the WHO International Health Regulations Emergency Committee declared an end to the 2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has affected more than 214 countries with at least 18000 deaths [1]. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Illness
- What is being tested?
- influenza vaccine, Imiquimod and Aqueous cream
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients at the age of 21 or above with chronic illness and given written informed consent
- Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Who cannot join
- Clinically significant immune-related diseases or significant recent co-morbidities
- Inability to comprehend and to follow all required study procedures
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- Have received 2011/2012 TIV
- Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
- Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients.
Show all 21Show fewer
- Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
- Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control measures during the first 3 weeks after vaccination.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long-term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed).
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Have known active human immunodeficiency virus (HIV) infection, acute hepatitis B or C infection, autoimmune hepatitis and related cirrhosis
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
- History of progressive or severe neurological disorders
- Have received any licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination (only exception being unadjuvanted seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations).
- Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination
- Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule
- Have a history of alcohol or drug abuse in the last 5 years.
- Have a history of Guillain-Barré Syndrome.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Effectiveness of Intradermal Trivalent Influenza Vaccine With Topical Imiquimod, a Double Blind Randomized Controlled Trial
Despite the WHO International Health Regulations Emergency Committee declared an end to the 2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has affected more than 214 countries with at least 18000 deaths [1]. Patients with chronic underlying illness and extreme of ages are at risk of developing severe disease and complications [2-3]. Resistance to oseltamivir has also been reported [4]. Therefore, vaccination with the 2010/2011 trivalent influenza vaccine (TIV) with the 2009 H1N1-like virus incorporated will be the best protection against the influenza infection, especially among the at risk population. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination [6]. Poor immunogenicity of the H1N1 2009 component of the trivalent influenza has been reported [7].
Study has also suggested the combined intradermal vaccination with local stimulation of dermal antigen presenting cells by applying imiquimod cream (Aldara) to the injection site, which activate antigen presenting cells (APC) through the toll-like receptor 7 (TLR7) may produce better immunogenicity [8].
Read more
Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma. Scientific evidence has demonstrated that after treatment with imiquimod, the antigen is processed and presented to cells of the adaptive immune system leading to clearance of the virus and subsequent clearance of the lesions [9]. In addition to functional maturation, imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes [10,11]. Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the antigen of interest, has shown to induce enhanced responses towards the administered antigen [12].
We therefore performed a prospective, double blind, randomized controlled study to compare the safety and immunogenicity between intradermal 2011/2012 TIV immunization with pretreatment of imiquimod cream and conventional full dose intramuscular 2011/2012 TIV immunization with pretreatment of aqueous cream as control.
Read the detailed description
References
- World Health Organization. Influenza A (H1N1) - update 95 [cited 2010 April 10]. Available from http://www.who.int/csr/don/2009_12_30/en/index.html
- Echevarria-Zuno S, Mejia-Arangure JM, Mar-Obeso AJ, et al. Infection and death from influenza A H1N1 virus in Mexico: a retrospective analysis. Lancet 2009; 374: 2072-9.
- Louie JK, Acosta M, Winter K, et al. Factors associated with death or hospitalization due to pandemic 2009 influenza A(H1N1) infection in California. JAMA 2009; 302: 1896-902.
- Jain S, Kamimoto L, Bramley AM, et al. Hospitalized patients with 2009 H1N1 influenza in the United States, April-June 2009. N Engl J Med 2009; 361:1935-44.
- Chen H, Cheung CL, Tai H, et al. Oseltamivir-resistant influenza A pandemic (H1N1) 2009 virus, Hong Kong, China. Emerg Infect Dis 2009;15:1970-2.
- Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009;27:454-9
- Myers CA, Faix DJ, Blair PJ. Possible reduced effectiveness of the 2009 H1N1 component of live, attenuated influenza vaccine. Clin Infect Dis. 2011;15;53:207-8.9.
- Roukens R, Vossen AC, Boland GJ, et al. Intradermal hepatitis B vaccination in non-responders after topical application of imiquimod (Aldara). Vaccine 2010;4288-4293.
- Tyring S, Conant M, Marini M, Van Der Meijden W, Washenik K. Imiquimod, an international update on therapeutic uses in dermatology. Int J Dermatol 2002;41(11):810-6.
- Burns Jr RP, Ferbel B, Tomai M, Miller R, Gaspari AA. The imidazoquinolines, imiquimod and R-848, induce functional, but not phenotypic, maturation of human epidermal Langerhans' cells. Clin Immunol 2000;94(1):13-23.
- Suzuki H, Wang B, Shivji GM, Toto P, Amerio P, Tomai MA, et al. Imiquimod, a topical immune response modifier, induces migration of Langerhans cells. J Invest Dermatol 2000;114(1):135-41.
- Thomsen LL, Topley P, Daly MG, Brett SJ, Tite JP. Imiquimod and resiquimod in a mouse model: adjuvants for DNA vaccination by particle-mediated immunotherapeutic delivery. Vaccine 2004;22(13-14):1799-809.
- Conditions
- Chronic Illness
- Being tested
- influenza vaccine, Imiquimod, Aqueous cream
- Keywords
- intradermal, influenza, vaccination
- Medical subject headings
- Chronic Disease, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccineBiological
Also called Intanza 15
single dose of intradermal 15 mcg non-adjuvanted 2011/2012 trivalent influenza vaccine
ImiquimodDrug
Also called Aldara
pretreatment with topical imiquimod cream to the injection site before vaccination
influenza vaccineBiological
Also called Intanza 15
single dose of intradermal 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine
Aqueous creamDrug
pretreatment with topical aqueous cream to the injection site before vaccination
influenza vaccineBiological
Also called Vaxigrip
single dose of intramuscular 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine
Aqueous creamDrug
pretreatment with topical aqueous cream to the injection site before vaccination
| Study group | Role | What they receive |
|---|---|---|
| IM vaccine and placebo cream | Active comparator | A single dose of intramuscular influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with aqueous cream Receives: Biological: influenza vaccine; Drug: Aqueous cream |
| ID vaccine and placebo cream | Active comparator | A single dose of intradermal influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with aqueous cream Receives: Biological: influenza vaccine; Drug: Aqueous cream |
| ID vaccine and imiquimod cream | Experimental | A single dose intradermal influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with imiquimod cream applied to the skin before vaccination Receives: Biological: influenza vaccine; Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
The percentage of subjects with an hemagglutination inhibition antibody titre <10 at baseline and a post-vaccination titre of ≥40 or a titre >10 at baseline and at least a four-fold increase in titre post-vaccination on day 7
Measured: day 7
Secondary outcomes (15)
Geometric mean titer old increase in influenza antibody titer
The GMT fold increase in influenza antibody titer by hemagglutination inhibition or microneutralization antibody assays on day 21 compared to day 0
Measured: day 21
Seroprotection rate
The percentage of subjects achieving an antibody titer achieving an influenza antibody titer of 1:40 or above by hemagglutination inhibition or microneutralization antibody assay on day 21
Measured: day 21
Adverse events (Immediate)
Patients who develop systemic or local adverse events within 30 minutes of vaccination
Measured: 30 minutes after vaccination
Geometric mean titer old increase in influenza antibody titer
The GMT fold increase in influenza antibody titer by hemagglutination inhibition or microneutralization antibody assay on day 7 compared to day 0
Measured: day 7
Seroprotection rate
The percentage of subjects achieving an antibody titer achieving an influenza antibody titer of 1:40 or above by hemagglutination inhibition or microneutralization antibody assay on day 7
Measured: day 7
Geometric mean titer old increase in influenza antibody titer
The GMT fold increase in influenza antibody titer by hemagglutination inhibition or microneutralization antibody assay at year 1 compared to day 0
Measured: year 1
Seroprotection rate
The percentage of subjects achieving an antibody titer achieving an influenza antibody titer of 1:40 or above by hemagglutination inhibition or microneutralization antibody assay at year 1
Measured: year 1
Seroconversion rate
The percentage of subjects with an hemagglutination inhibition antibody titre <10 at baseline and a post-vaccination titre of ≥40 or a titre >10 at baseline and at least a four-fold increase in titre post-vaccination at year 1
Measured: Year 1
Adverse events (7 days)
Patients who develop systemic or local adverse events within 1 week of vaccination
Measured: 7 days after vaccination
Seroconversion rate
The percentage of subjects with an hemagglutination inhibition antibody titre <10 at baseline and a post-vaccination titre of ≥40 or a titre >10 at baseline and at least a four-fold increase in titre post-vaccination on day 21
Measured: Day 21
Geometric mean titer old increase in influenza antibody titer
The GMT fold increase in influenza antibody titer by hemagglutination inhibition or microneutralization antibody assay at year 1 compared to day 0
Measured: Day 14
Seroprotection rate
The percentage of subjects achieving an antibody titer achieving an influenza antibody titer of 1:40 or above by hemagglutination inhibition or microneutralization antibody assay at year 1
Measured: Day 14
Seroconversion rate
The percentage of subjects with an hemagglutination inhibition antibody titre <10 at baseline and a post-vaccination titre of ≥40 or a titre >10 at baseline and at least a four-fold increase in titre post-vaccination at year 1
Measured: Day 14
Effectiveness
hospitalization for pneumonia or influenza
Measured: 1 year post vaccination
Effectiveness
Nasopharyngeal sample positive for influenza A
Measured: 1 year post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ivan FN Hung, The University of Hong Kong
- Investigators
- Ivan FN Hung, MD FRCP, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508884
- Sponsor's protocol ID
- HKU-2012-432
- Status last verified
- Dec 2013
- First submitted
- 9 Jan 2012
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Effectiveness of Intradermal Trivalent Influenza Vaccine With Topical Imiquimod, a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01508884
- Acronym / sponsor ID
- HKU-2012-432
- Conditions
- Chronic Illness
- Keywords
- intradermal, influenza, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the WHO International Health Regulations Emergency Committee declared an end to the 2009 H1N1 pandemic globally, the emergence of the novel 2009 H1N1 virus in March 2009 has affected more than 214 countries with at least 18000 deaths [1]. Patients with chronic underlying illness and extreme of ages are at risk of developing severe disease and complications [2-3]. Resistance to oseltamivir has also been reported [4]. Therefore, vaccination with the 2010/2011 trivalent influenza vaccine (TIV) with the 2009 H1N1-like virus incorporated will be the best protection against the influenza infection, especially among the at risk population. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination [6]. Poor immunogenicity of the H1N1 2009 component of the trivalent influenza has been reported [7].
Study has also suggested the combined intradermal vaccination with local stimulation of dermal antigen presenting cells by applying imiquimod cream (Aldara) to the injection site, which activate antigen presenting cells (APC) through the toll-like receptor 7 (TLR7) may produce better immunogenicity [8].
Imiquimod cream is currently registered for the treatment of warts and basal cell carcinoma. Scientific evidence has demonstrated that after treatment with imiquimod, the antigen is processed and presented to cells of the adaptive immune system leading to clearance of the virus and subsequent clearance of the lesions [9]. In addition to functional maturation, imiquimod induces migration of dendritic cells from the dermis to draining lymph nodes [10,11]. Subcutaneous administration of imiquimod as vaccine adjuvant simultaneously with the antigen of interest, has shown to induce enhanced responses towards the administered antigen [12].
We therefore performed a prospective, double blind, randomized controlled study to compare the safety and immunogenicity between intradermal 2011/2012 TIV immunization with pretreatment of imiquimod cream and conventional full dose intramuscular 2011/2012 TIV immunization with pretreatment of aqueous cream as control.
Detailed description
References
- World Health Organization. Influenza A (H1N1) - update 95 [cited 2010 April 10]. Available from http://www.who.int/csr/don/2009_12_30/en/index.html
- Echevarria-Zuno S, Mejia-Arangure JM, Mar-Obeso AJ, et al. Infection and death from influenza A H1N1 virus in Mexico: a retrospective analysis. Lancet 2009; 374: 2072-9.
- Louie JK, Acosta M, Winter K, et al. Factors associated with death or hospitalization due to pandemic 2009 influenza A(H1N1) infection in California. JAMA 2009; 302: 1896-902.
- Jain S, Kamimoto L, Bramley AM, et al. Hospitalized patients with 2009 H1N1 influenza in the United States, April-June 2009. N Engl J Med 2009; 361:1935-44.
- Chen H, Cheung CL, Tai H, et al. Oseltamivir-resistant influenza A pandemic (H1N1) 2009 virus, Hong Kong, China. Emerg Infect Dis 2009;15:1970-2.
- Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009;27:454-9
- Myers CA, Faix DJ, Blair PJ. Possible reduced effectiveness of the 2009 H1N1 component of live, attenuated influenza vaccine. Clin Infect Dis. 2011;15;53:207-8.9.
- Roukens R, Vossen AC, Boland GJ, et al. Intradermal hepatitis B vaccination in non-responders after topical application of imiquimod (Aldara). Vaccine 2010;4288-4293.
- Tyring S, Conant M, Marini M, Van Der Meijden W, Washenik K. Imiquimod, an international update on therapeutic uses in dermatology. Int J Dermatol 2002;41(11):810-6.
- Burns Jr RP, Ferbel B, Tomai M, Miller R, Gaspari AA. The imidazoquinolines, imiquimod and R-848, induce functional, but not phenotypic, maturation of human epidermal Langerhans' cells. Clin Immunol 2000;94(1):13-23.
- Suzuki H, Wang B, Shivji GM, Toto P, Amerio P, Tomai MA, et al. Imiquimod, a topical immune response modifier, induces migration of Langerhans cells. J Invest Dermatol 2000;114(1):135-41.
- Thomsen LL, Topley P, Daly MG, Brett SJ, Tite JP. Imiquimod and resiquimod in a mouse model: adjuvants for DNA vaccination by particle-mediated immunotherapeutic delivery. Vaccine 2004;22(13-14):1799-809.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IM vaccine and placebo cream | Active comparator | Biological: influenza vaccine, Drug: Aqueous creamA single dose of intramuscular influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with aqueous cream |
| ID vaccine and placebo cream | Active comparator | Biological: influenza vaccine, Drug: Aqueous creamA single dose of intradermal influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with aqueous cream |
| ID vaccine and imiquimod cream | Experimental | Biological: influenza vaccine, Drug: ImiquimodA single dose intradermal influenza vaccine (15ug non-adjuvanted 2011/2012 TIV) with pre-treatment of the injected skin with imiquimod cream applied to the skin before vaccination |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients at the age of 21 or above with chronic illness and given written informed consent
- Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Key exclusion criteria (21 listed)
- Clinically significant immune-related diseases or significant recent co-morbidities
- Inability to comprehend and to follow all required study procedures
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- Have received 2011/2012 TIV
- Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza vaccineAlso: Intanza 15single dose of intradermal 15 mcg non-adjuvanted 2011/2012 trivalent influenza vaccine | Biological | ID vaccine and imiquimod cream |
| ImiquimodAlso: Aldarapretreatment with topical imiquimod cream to the injection site before vaccination | Drug | ID vaccine and imiquimod cream |
| influenza vaccineAlso: Intanza 15single dose of intradermal 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine | Biological | ID vaccine and placebo cream |
| Aqueous creampretreatment with topical aqueous cream to the injection site before vaccination | Drug | ID vaccine and placebo cream |
| influenza vaccineAlso: Vaxigripsingle dose of intramuscular 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine | Biological | IM vaccine and placebo cream |
| Aqueous creampretreatment with topical aqueous cream to the injection site before vaccination | Drug | IM vaccine and placebo cream |
Primary outcome
Seroconversion rate
Time frame: day 7
The percentage of subjects with an hemagglutination inhibition antibody titre <10 at baseline and a post-vaccination titre of ≥40 or a titre >10 at baseline and at least a four-fold increase in titre post-vaccination on day 7
15 secondary outcomes
Geometric mean titer old increase in influenza antibody titer
Time frame: day 21
Seroprotection rate
Time frame: day 21
Adverse events (Immediate)
Time frame: 30 minutes after vaccination
Geometric mean titer old increase in influenza antibody titer
Time frame: day 7
Seroprotection rate
Time frame: day 7
Geometric mean titer old increase in influenza antibody titer
Time frame: year 1
Seroprotection rate
Time frame: year 1
Seroconversion rate
Time frame: Year 1
Adverse events (7 days)
Time frame: 7 days after vaccination
Seroconversion rate
Time frame: Day 21
Geometric mean titer old increase in influenza antibody titer
Time frame: Day 14
Seroprotection rate
Time frame: Day 14
Seroconversion rate
Time frame: Day 14
Effectiveness
Time frame: 1 year post vaccination
Effectiveness
Time frame: 1 year post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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.
Ivan FN Hung, MD FRCP principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing influenza vaccine, Imiquimod and Aqueous cream in people with Chronic Illness, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 21 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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.
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?
Seroconversion rate (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2013.