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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000306910

Enrollment

Registered

2011-03-23

Start date

2011-03-28

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

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

Outcome results