Influenza, HumanPhase 4NCT02101749
Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.
A Phase 4 study testing trivalent inactivated influenza in people with Influenza, Human, run by Mahidol University at 1 site in Thailand.
Trial summary
This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms: 1. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants) 2. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- trivalent inactivated influenza
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to Mar 2014
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 60 years
- Healthy and/or medically stable with controlled chronic medical conditions (e.g. diabetes mellitus, hypertension ) able to help oneself
Who cannot join
- Known history of systemic hypersensitivity to egg or chicken proteins or any of the vaccine components
- Influenza infection within the past 3 months
- History of Guillain Barre Syndrome (GBS) or brachial neuritis within 6 weeks of previous influenza vaccination
- Treatment with immunosuppressive or other immune-modifying drugs or cancer therapy within the past 6 months
- Any concomitant medication with aspirin
- Participation in other intervention study
- Incapacity to provide fully informed consent or be attentive to follow-up observations resulting from cognitive impairment, abuse of alcohol or drug addiction
- Random blood for Dextrostix more than 200 mg/dL
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
Bangkok, Bangkok, 10400
About this study
Official title: Comparative Immune Response of Intradermal and Intramuscular Preparations of
This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms:
- Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants)
- Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.
Read the detailed description
The consent form will be reviewed and signed by the participant prior to any study-related procedures.
Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1.
A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine [group A] or seasonal intramuscular influenza vaccine [group B]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.
- Conditions
- Influenza, Human
- Being tested
- trivalent inactivated influenza
- Keywords
- trivalent inactivated influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent inactivated influenzaBiological
intradermal or intramuscular injection in the deltoid area.
| Study group | Role | What they receive |
|---|---|---|
| trivalent inactivated influenza (INTANZA) | Active comparator | Intradermal injection Receives: Biological: trivalent inactivated influenza |
| trivalent inactivated influenza (VAXIGRIP) | Active comparator | Intramuscle injection Receives: Biological: trivalent inactivated influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological end point
Vaccine is able to induce a 4-fold rise of Hemagglutination inhibition antibodies 70% of vaccinees within 60 days after vaccination (according to EMA (European Medicines Agency) and CBER (Center for Biologics Evaluation and Research) guidelines)
Measured: with in 60 days post vaccination
Secondary outcomes (1)
To assess safety
To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Punnee Pitisuttithum, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101749
- Sponsor's protocol ID
- Elderly Flu vaccine
- Status last verified
- Mar 2016
- First submitted
- 28 Dec 2013
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boonnak K, Dhitavat J, Thantamnu N, Kosoltanapiwat N, Auayporn M, Jiang L, Puthavathana P, Pitisuttithum P. Immune responses to intradermal and intramuscular inactivated influenza vaccine among older age group. Vaccine. 2017 Dec 19;35(52):7339-7346. doi: 10.1016/j.vaccine.2017.10.106. Epub 2017 Nov 20.
PubMed 29157960
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Immune Response of Intradermal and Intramuscular Preparations of
- ClinicalTrials.gov ID
- NCT02101749
- Acronym / sponsor ID
- Elderly Flu vaccine
- Conditions
- Influenza, Human
- Keywords
- trivalent inactivated influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Apr 2014 (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.
This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms:
- Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants)
- Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.
Detailed description
The consent form will be reviewed and signed by the participant prior to any study-related procedures.
Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1.
A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine [group A] or seasonal intramuscular influenza vaccine [group B]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trivalent inactivated influenza (INTANZA) | Active comparator | Biological: trivalent inactivated influenzaIntradermal injection |
| trivalent inactivated influenza (VAXIGRIP) | Active comparator | Biological: trivalent inactivated influenzaIntramuscle injection |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged ≥ 60 years
- Healthy and/or medically stable with controlled chronic medical conditions (e.g. diabetes mellitus, hypertension ) able to help oneself
Key exclusion criteria (8 listed)
- Known history of systemic hypersensitivity to egg or chicken proteins or any of the vaccine components
- Influenza infection within the past 3 months
- History of Guillain Barre Syndrome (GBS) or brachial neuritis within 6 weeks of previous influenza vaccination
- Treatment with immunosuppressive or other immune-modifying drugs or cancer therapy within the past 6 months
- Any concomitant medication with aspirin
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 |
|---|---|---|
| trivalent inactivated influenzaintradermal or intramuscular injection in the deltoid area. | Biological | trivalent inactivated influenza (INTANZA), trivalent inactivated influenza (VAXIGRIP) |
Primary outcome
Immunological end point
Time frame: with in 60 days post vaccination
Vaccine is able to induce a 4-fold rise of Hemagglutination inhibition antibodies 70% of vaccinees within 60 days after vaccination (according to EMA (European Medicines Agency) and CBER (Center for Biologics Evaluation and Research) guidelines)
1 secondary outcome
To assess safety
Time frame: 60 Days
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 23 Mar 2016.
- Derived from this study: PubMed 29157960Boonnak K, Dhitavat J, Thantamnu N, Kosoltanapiwat N, Auayporn M, Jiang L, Puthavathana P, Pitisuttithum P. Immune responses to intradermal and intramuscular inactivated influenza vaccine among older age group. Vaccine. 2017 Dec 19;35(52):7339-7346. doi: 10.1016/j.vaccine.2017.10.106. Epub 2017 Nov 20.
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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.
Punnee Pitisuttithum, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trivalent inactivated influenza in people with Influenza, Human, run by Mahidol University at 1 site in Thailand.
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 8 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 23 Mar 2016. 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 Thailand. 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?
Immunological end point (time frame: with in 60 days post vaccination). 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 NCT02101749, 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 23 Mar 2016.