Phase 1
Completed N=50
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Source: ClinicalTrials.gov NCT01216332 ↗Enrolled (actual)
50
Serious AEs
30.0%
Results posted
May 2019
Primary outcomePrimary: Local Reactions After Each Vaccination — 12; 7; 14; 9 Participants
Summary
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Reactions After Each Vaccination |
12; 7; 14; 9; 3; 3 | — |
| PRIMARY Systemic Reaction |
14; 14; 13; 7; 4; 3 | — |
| SECONDARY Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise |
6; 6; 8; 5; 2; 0 | — |
| SECONDARY Immunogenicity:Number of Participants With a Pre-titer ≥1:40 |
17; 9; 9; 7; 21; 11 | — |
| SECONDARY Immunogenicity: Number of Participants With a Post-titer ≥1:40 |
20; 11; 13; 8; 19; 9 | — |
| SECONDARY Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants |
46.2; 87.4; 28.3; 28.8; 66.5; 56.1 | — |
| SECONDARY Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants |
97.9; 322.9; 62.9; 76.5; 74.4; 50.6 | — |
Eligibility Criteria
Inclusion Criteria
- Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
- Must be in 1st complete remission.
- Must be 4 weeks into maintenance therapy.
- 17 years of age, inclusive.
- Available for duration of study.
Exclusion Criteria
- History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.
- History of Guillain-Barre syndrome.
- Evidence of relapsed disease.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- Have any condition that the investigator believes may interfere with successful completion of the study.
- History of receiving 2010 - 2011 influenza vaccine.
- Pregnant female.
- History of proven influenza disease after September 1, 2010.
Data sourced from ClinicalTrials.gov (NCT01216332). 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.