Phase 2
Completed N=105
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
Cancer · Influenza Viral Infections
Source: ClinicalTrials.gov NCT01666782 ↗
Enrolled (actual)
105
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: 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. — 125.2; 266.1; 134.1; 143.2 titers
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 chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
125.2; 266.1; 134.1; 143.2; 31.4; 54.7 | — |
| SECONDARY The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. |
96; 90; 96; 96; 88; 72 | — |
| SECONDARY The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old. |
72; 46; 80; 58; 80; 44 | — |
| SECONDARY Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines. |
13; 10; 3; 1; 4; 2 | — |
| SECONDARY Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines. |
2; 1; 1; 1; 0; 0 | — |
| SECONDARY Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines. |
6; 4; 1; 0; 3; 11 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Adequate organ function:
- ANC >1000/mm3
- Platelet >100,000/uL
- Creatinine <2 mg/dL
- AST and ALT <3 times the ULN
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01666782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.