Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000306910
Ethics application status
Approved
Date submitted
16/03/2011
Date registered
23/03/2011
Date last updated
23/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Seasonal Influenza Vaccine (SIV) or “Flu vaccine” in cancer patients undergoing chemotherapy.
Scientific title
Phase II trial to study the efficacy of seasonal influenza vaccine in cancer patients undergoing chemotherapy
Secondary ID [1] 259803 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Efficacy of flu vaccine in cancer patient undergoing chemotherapy 261383 0
Condition category
Condition code
Cancer 259539 259539 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Efficacy of flu vaccine. Patients receiving chemotherapy will be given 0.5 ml of the trivalent seasonal flu vaccine for 2011, intramuscular or deep sub cutaneous, approximately 7 days before the next dose of chemotherapy. This will be a once off intervention. Blood will be drawn at baseline, 3-4 weeks, 6-7 weeks and 6 months after the vaccine dose and will be analysed for Influenza antibody levels.
Intervention code [1] 264233 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262346 0
Sero conversion rates at 3-4 weeks after flu vaccination will be estimated from serum. Blood will be spun and serum analysed in batches, for influenza antibody levels by quantitative Haemagglutination Inhibition technique.
Timepoint [1] 262346 0
3-4 weeks
Secondary outcome [1] 273592 0
Late seroconversion at 6-7 weeks
Blood will be spun and serum analysed in batches, for influenza antibody levels by quantitative Haemagglutination Inhibition technique.
Timepoint [1] 273592 0
6-7 weeks
Secondary outcome [2] 273593 0
Sustained sero protection at 6 months
Blood will be spun and serum analysed in batches, for influenza antibody levels by quantitative Haemagglutination Inhibition technique.
Timepoint [2] 273593 0
6 months

Eligibility
Key inclusion criteria
Subjects > 18yrs with histologically/cytologically confirmed neoplasm starting chemotherapy or already on chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior immunization with SIV in the current season
2. Known sensitivity to Influenza vaccine, eggs,
antibiotics - neomycin or polymyxin.
3. History of Guillain-Barre Syndrome
4. Fever (greater than 38.5 degrees Celsius) at time of
administration of Fluvax

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 264681 0
Self funded/Unfunded
Name [1] 264681 0
Department of Medical Oncology/ Infectious disease
Country [1] 264681 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical centre
Address
Flinders Medical centre, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 263816 0
None
Name [1] 263816 0
Address [1] 263816 0
Country [1] 263816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266674 0
Human Research Ethics comittee
Ethics committee address [1] 266674 0
Flinders Medical Centre, Flinders drive, Bedford Park SA 5042
Ethics committee country [1] 266674 0
Australia
Date submitted for ethics approval [1] 266674 0
Approval date [1] 266674 0
18/02/2011
Ethics approval number [1] 266674 0
1/10/0306

Summary
Brief summary
This study is designed to study the efficacy of flu vaccine in patients with cancer undergoing chemotherapy, by assessing the antibody response to flu vaccination to see if they reach 'protective' levels

Who is it for?

You may join this study if you are over 18 years of age, have a histologically or cytologically confirmed neoplasm, and are about to start chemotherapy or currently already on chemotherapy.

Trial Details

Patients receiving chemotherapy will be given 0.5 ml of the trivalent seasonal flu vaccine for 2011, intramuscular or deep subcutaneous, approximately 7 days before the next dose of chemotherapy. This will be a once off intervention. Blood will be drawn at baseline, 3-4 weeks, 6-7 weeks and 6 months after the vaccine dose and will be analysed for Influenza antibody levels.

The aim of this study is to investigate the efficacy of flu vaccine in cancer patient undergoing chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32352 0
Address 32352 0
Country 32352 0
Phone 32352 0
Fax 32352 0
Email 32352 0
Contact person for public queries
Name 15599 0
Alison Richards
Address 15599 0
Clinical Trials Manager
Department of Medical Oncology
Flinders Medical Centre, Flinders drive
Bedford Park SA 5042
Australia
Country 15599 0
Australia
Phone 15599 0
+61 8 8204 4830
Fax 15599 0
+61 8 8204 4765
Email 15599 0
[email protected]
Contact person for scientific queries
Name 6527 0
Dr Shawgi Sukumaran
Address 6527 0
Department of Medical Oncology
Flinders Medical Centre, Flinders drive
Bedford Park SA 5042
Australia
Country 6527 0
Australia
Phone 6527 0
+61 8 82045511
Fax 6527 0
Email 6527 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of influenza vaccine (Fluvax) in cancer patients on treatment: a prospective single arm, open-label study.2020https://dx.doi.org/10.1007/s00520-020-05384-2
N.B. These documents automatically identified may not have been verified by the study sponsor.