CancerNCT02213432
Influenza Vaccination in Cancer Patients
A study testing Different timing of influenza vaccination in people with Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Different timing of influenza vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Aug 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.
- Specific definition of each term is like following:
- The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.
- Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.
- Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.
- Patients who did not receive the influenza vaccination yet in the current year.
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- Older than 19 years
- Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
- Cell blood count meets following criteria:
- Neutrophile count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 8 g/dL
- Patients who can understand and agreed with the informed consents.
Who cannot join
- Patients who have any contraindication for influenza vaccination.
- Patients who are supposed to receive the last chemotherapy at the enrollment
- Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
- Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
- Patients with HIV and low CD 4+ T cell count (< 500/uL)
- Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
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- Patients who have transplanted organ and receive immunosuppressants
- Patients who are supposed to get prophylactic G-CSF after chemotherapy
- Patients who are suspected to have active infectious disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.
Read the detailed description
The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group.
Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.
As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.
Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.
All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).
- Conditions
- Cancer
- Being tested
- Different timing of influenza vaccination
- Keywords
- influenza vaccine, cancer
- Medical subject headings
- Neoplasms, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different timing of influenza vaccinationBiological
The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.
| Study group | Role | What they receive |
|---|---|---|
| Day 1 vaccination | Experimental | Different timing of influenza vaccination: Day 1
Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts. Receives: Biological: Different timing of influenza vaccination |
| Day 11 vaccination | Active comparator | Different timing of influenza vaccination: Day 11
Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts Receives: Biological: Different timing of influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate
The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)
Measured: 21-28 days after vaccination
Secondary outcomes (4)
Seroconversion factor
Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple.
Measured: 21-28 days after vaccination
Seroconversion rate
Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre
Measured: 21-28 days after vaccination
Geometric mean titre of HI
Geometric mean titers of HI (haemagglutination inhibition) after vaccination
Measured: 21-28 days after vaccination
Vaccine-related adverse events
the proportion of patients with any or serious vaccine-related adverse events
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionAug 2015
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Responsible party
- Principal investigator, Wan Beom Park, Seoul National University Hospital
- Investigators
- Wan Beom Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213432
- Sponsor's protocol ID
- 1407-057-593
- Status last verified
- Feb 2016
- First submitted
- 7 Aug 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT02213432
- Acronym / sponsor ID
- 1407-057-593
- Conditions
- Cancer
- Keywords
- influenza vaccine, cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Aug 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.
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.
Detailed description
The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group.
Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.
As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.
Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.
All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 1 vaccination | Experimental | Biological: Different timing of influenza vaccinationDifferent timing of influenza vaccination: Day 1 Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts. |
| Day 11 vaccination | Active comparator | Biological: Different timing of influenza vaccinationDifferent timing of influenza vaccination: Day 11 Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.
- Patients who did not receive the influenza vaccination yet in the current year.
- Older than 19 years
- Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
- Cell blood count meets following criteria:
Key exclusion criteria (9 listed)
- Patients who have any contraindication for influenza vaccination.
- Patients who are supposed to receive the last chemotherapy at the enrollment
- Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
- Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
- Patients with HIV and low CD 4+ T cell count (< 500/uL)
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 |
|---|---|---|
| Different timing of influenza vaccinationThe timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11. | Biological | Day 1 vaccination, Day 11 vaccination |
Primary outcome
Seroprotection rate
Time frame: 21-28 days after vaccination
The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)
4 secondary outcomes
Seroconversion factor
Time frame: 21-28 days after vaccination
Seroconversion rate
Time frame: 21-28 days after vaccination
Geometric mean titre of HI
Time frame: 21-28 days after vaccination
Vaccine-related adverse events
Time frame: within 28 days
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Wan Beom Park, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different timing of influenza vaccination in people with Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 13 inclusion and 9 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: stopped early, as of the sponsor's last update on 24 Feb 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 South Korea. 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 was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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?
Seroprotection rate (time frame: 21-28 days after vaccination). 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 24 Feb 2016.