Not Yet RecruitingPhase 2ACTRN12611000306910

Efficacy of Seasonal Influenza Vaccine (SIV) or “Flu vaccine” in cancer patients undergoing chemotherapy.

Phase II trial to study the efficacy of seasonal influenza vaccine in cancer patients undergoing chemotherapy

Sponsor

Flinders Medical centre

Enrollment

50 participants

Start Date

Mar 28, 2011

Study Type

Interventional

Conditions

Efficacy of flu vaccine in cancer patient undergoing chemotherapy

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Subjects > 18yrs with histologically/cytologically confirmed neoplasm starting chemotherapy or already on chemotherapy.

Exclusion Criteria6

Prior immunization with SIV in the current season
Known sensitivity to Influenza vaccine, eggs,
antibiotics - neomycin or polymyxin.
History of Guillain-Barre Syndrome
Fever (greater than 38.5 degrees Celsius) at time of
administration of Fluvax

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Interventions

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

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.

Locations(1)

SA, Australia

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ACTRN12611000306910