CancerPhase 2IMMUNENCT01666782
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
A Phase 2 study testing Standard Trivalent Influenza Vaccine and High-Dose Influenza Vaccine in people with Cancer and Influenza Viral Infections, run by Saad Jamshed MD at 2 sites in United States.
Trial summary
The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cancer, Influenza Viral Infections
- What is being tested?
- Standard Trivalent Influenza Vaccine and High-Dose Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old to less than 65 years old
- Subjects with malignancy must be receiving chemotherapy
- Medically stable
- Able to understand and willingness to sign a written informed consent
- Able to comply with study procedures
- Life expectancy of more than 3 months
Show all 11Show fewer
- Adequate organ function:
- ANC >1000/mm3
- Platelet >100,000/uL
- Creatinine <2 mg/dL
- AST and ALT <3 times the ULN
Who cannot join
- Allergy to eggs
- Prior allergy to Influenza Vaccine
- History of Guillain-Barre Syndrome
- Current febrile illness
- Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
- Autologous or Allogenic Stem Cell Transplant with in a year
- Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rochester General Hospital
Rochester, New York, 14621
Lipson Cancer Center Linden Oaks Medical Campus
Rochester, New York, 14625
About this study
Official title: A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.
- Conditions
- Cancer, Influenza Viral Infections
- Being tested
- Standard Trivalent Influenza Vaccine, High-Dose Influenza Vaccine
- Keywords
- Influenza vaccine, Oncology, Chemotherapy
- 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.
Standard Trivalent Influenza VaccineBiological
Also called Fluzone
Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
High-Dose Influenza VaccineBiological
Also called Fluzone High-Dose
Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Influenza Vaccine | Experimental | Not described Receives: Biological: High-Dose Influenza Vaccine |
| Standard Trivalent Influenza Vaccine | Active comparator | Not described Receives: Biological: Standard Trivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
Measured: Baseline and 28 days
Secondary outcomes (5)
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
Measured: 28 days
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.
Measured: Baseline and 28 days
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Measured: 7 days
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
Measured: 7 days
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saad Jamshed MD
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Saad Jamshed MD, Rochester General Hospital
- Investigators
- Saad Jamshed, MD, Principal investigator, Rochester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666782
- Sponsor's protocol ID
- CIC 1336-B12-1
- Acronym
- IMMUNE
- Status last verified
- May 2016
- First submitted
- 14 Aug 2012
- Last updated
- 24 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22.
PubMed 26721330
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01666782
- Acronym / sponsor ID
- IMMUNE / CIC 1336-B12-1
- Conditions
- Cancer, Influenza Viral Infections
- Keywords
- Influenza vaccine, Oncology, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Saad Jamshed MDUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 24 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Dose Influenza Vaccine | Experimental | Biological: High-Dose Influenza Vaccine |
| Standard Trivalent Influenza Vaccine | Active comparator | Biological: Standard Trivalent Influenza Vaccine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18 years old to less than 65 years old
- Subjects with malignancy must be receiving chemotherapy
- Medically stable
- Able to understand and willingness to sign a written informed consent
- Able to comply with study procedures
Key exclusion criteria (7 listed)
- Allergy to eggs
- Prior allergy to Influenza Vaccine
- History of Guillain-Barre Syndrome
- Current febrile illness
- Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
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 |
|---|---|---|
| Standard Trivalent Influenza VaccineAlso: FluzoneEach 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient. | Biological | Standard Trivalent Influenza Vaccine |
| High-Dose Influenza VaccineAlso: Fluzone High-DoseEach 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient. | Biological | High-Dose Influenza Vaccine |
Primary outcome
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
Time frame: Baseline and 28 days
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
5 secondary outcomes
The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Time frame: 28 days
The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
Time frame: Baseline and 28 days
Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
Time frame: 7 days
Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
Time frame: 7 days
Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26721330Jamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22.
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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.
Saad Jamshed, MD principal investigator
Rochester General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Trivalent Influenza Vaccine and High-Dose Influenza Vaccine in people with Cancer and Influenza Viral Infections, run by Saad Jamshed MD at 2 sites in United States.
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 11 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 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old. (time frame: Baseline and 28 days). 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 NCT01666782, 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 24 Jun 2016.