InfluenzaNCT01304563
2010/2011 Trivalent Influenza Vaccination
A study testing TIV 2010/2011 influenza vaccine and INT in people with Influenza, run by The University of Hong Kong at 1 site in China.
Trial summary
Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- TIV 2010/2011 influenza vaccine and INT
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Feb 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants qualified for the HA/ CHP Mass Vaccination Program for TIV 2010/2011 seasonal influenza as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above that are either healthcare workers or that have a chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure.
- All patients give written informed consent.
- Subjects must be available to complete the study and comply with study procedures.
Who cannot join
- Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers.
- 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 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.
- 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 known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection or autoimmune hepatitis and cirrhosis.
- History of progressive or severe neurological disorders or Guillain-Barré Syndrome.
Trial locations and contacts
1 site in 1 country.
China1 site
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
About this study
Official title: Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device
Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.
Read the detailed description
This is a prospective, randomized, single centre trial in the Queen Mary Hospital. We aim to recruit 400 subjects [with a minimum of 50 subjects per group] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for 2010/2011 TIV. These patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness (or healthcare workers). Subjects will be randomly assigned into 4 groups: Group 1 (ID1) to receive a single low-dose intradermal injection of 2010/2011 TIV, with a microneedle device. Group 2 (ID2) to receive a single higher low-dose intradermal injection of 2010/2011 TIV with a microneedle device. Group 3 (IM15) to receive a single full-dose (15ug) standard 2010/2011 TIV delivered intramuscularly by conventional needle. Group 4 (INT) to receive a single low-dose intradermal injection of 2010/2011 TIV, with Intanza® needle. The 2010/2011 TIV used will be Fluzone®, Sanofi-Pasteur for group 3 and Intanza®, Sanofi-Pasteur for group 1,2 and 4.
- Conditions
- Influenza
- Being tested
- TIV 2010/2011 influenza vaccine, INT
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIV 2010/2011 influenza vaccineBiological
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
TIV 2010/2011 influenza vaccineBiological
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
TIV 2010/2011 influenza vaccineBiological
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
INTBiological
Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental
| Study group | Role | What they receive |
|---|---|---|
| IM15 | Active comparator | 15 mcg TIV 2010/2011 influenza vaccine delivered via intramuscular injection (control) Receives: Biological: TIV 2010/2011 influenza vaccine |
| ID1 | Active comparator | Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet) Receives: Biological: TIV 2010/2011 influenza vaccine |
| ID2 | Active comparator | Higher low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet) Receives: Biological: TIV 2010/2011 influenza vaccine |
| INT | Active comparator | Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device Receives: Biological: INT |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rate
Seroconversion rate (percentage of subjects with a fourfold increase in antibody titres, providing a minimal post vacination titre of 1:40) on day 21 by TIV 2010/2011 hemagglutination inhibition (HI) between the ID and IM groups
Measured: day 21
Secondary outcomes (2)
Adverse events
Adverse events secondary to vaccination with different devices
Measured: 30 minutes post vaccination
Seroprotection rate
percentage of subjects with a post vaccination titre of at least 1:40
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304563
- Sponsor's protocol ID
- HKU-2010-149
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device
- ClinicalTrials.gov ID
- NCT01304563
- Acronym / sponsor ID
- HKU-2010-149
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Feb 2011 (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.
Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.
Detailed description
This is a prospective, randomized, single centre trial in the Queen Mary Hospital. We aim to recruit 400 subjects [with a minimum of 50 subjects per group] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for 2010/2011 TIV. These patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness (or healthcare workers). Subjects will be randomly assigned into 4 groups: Group 1 (ID1) to receive a single low-dose intradermal injection of 2010/2011 TIV, with a microneedle device. Group 2 (ID2) to receive a single higher low-dose intradermal injection of 2010/2011 TIV with a microneedle device. Group 3 (IM15) to receive a single full-dose (15ug) standard 2010/2011 TIV delivered intramuscularly by conventional needle. Group 4 (INT) to receive a single low-dose intradermal injection of 2010/2011 TIV, with Intanza® needle. The 2010/2011 TIV used will be Fluzone®, Sanofi-Pasteur for group 3 and Intanza®, Sanofi-Pasteur for group 1,2 and 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IM15 | Active comparator | Biological: TIV 2010/2011 influenza vaccine15 mcg TIV 2010/2011 influenza vaccine delivered via intramuscular injection (control) |
| ID1 | Active comparator | Biological: TIV 2010/2011 influenza vaccineLow dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet) |
| ID2 | Active comparator | Biological: TIV 2010/2011 influenza vaccineHigher low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet) |
| INT | Active comparator | Biological: INTLow dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants qualified for the HA/ CHP Mass Vaccination Program for TIV 2010/2011 seasonal influenza as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above that are either healthcare workers or that have a chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure.
- All patients give written informed consent.
- Subjects must be available to complete the study and comply with study procedures.
Key exclusion criteria (7 listed)
- Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers.
- 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 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.
- 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.
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 |
|---|---|---|
| TIV 2010/2011 influenza vaccineTIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control | Biological | IM15 |
| TIV 2010/2011 influenza vaccineLow dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental | Biological | ID1 |
| TIV 2010/2011 influenza vaccineHigher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental | Biological | ID2 |
| INTLow dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental | Biological | INT |
Primary outcome
seroconversion rate
Time frame: day 21
Seroconversion rate (percentage of subjects with a fourfold increase in antibody titres, providing a minimal post vacination titre of 1:40) on day 21 by TIV 2010/2011 hemagglutination inhibition (HI) between the ID and IM groups
2 secondary outcomes
Adverse events
Time frame: 30 minutes post vaccination
Seroprotection rate
Time frame: Day 21
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 25 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIV 2010/2011 influenza vaccine and INT in people with Influenza, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 7 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 25 Feb 2011. 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 China. 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 21). 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 25 Feb 2011.