drugset / Trial / NCT00307710
Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma
Phase 2
Completed
28 enrolled
M.D. Anderson Cancer Center
National Institutes of Health (NIH) · collab
RandomizedSingle-groupDouble-blindTreatment
Summary
Primary Objective: To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is defined as a 4-fold or greater increase in serum antibody. Secondary Objective: To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.
Timeline
- Start
- 2004-08
- Primary completion
- 2007-02
- Completion
- 2007-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trivalent Baculovirus-expressed Influenza HA vaccine | Vaccine | 15 ug | Intramuscular |
| Subject | Trivalent Baculovirus-expressed Influenza HA vaccine | Vaccine | 45 ug | Intramuscular |
| Subject | Trivalent Baculovirus-expressed Influenza HA vaccine | Vaccine | 135 ug | Intramuscular |
| Subject | standard inactivated influenza vaccine | Vaccine | — | Intramuscular |