Phase 2
Completed N=84
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Source: ClinicalTrials.gov NCT01205581 ↗Enrolled (actual)
84
Serious AEs
1.2%
Results posted
Sep 2014
Primary outcomePrimary: Rate of Seroconversion After 1 Dose of Vaccine — 31; 0; 50; 22 percentage of participants
Summary
This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Seroconversion After 1 Dose of Vaccine |
31; 0; 50; 22; 61; 65 | — |
| PRIMARY Rate of Seroprotection After 1 Dose of Vaccine |
77; 85; 75; 78; 100; 100 | — |
| PRIMARY Number of Participants Achieving Seroprotection After Second Dose of Vaccine |
11; 12; 7; 9; 18; 19 | — |
| SECONDARY Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD |
1; 0 | — |
| SECONDARY Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD |
31; 54; 50; 88; 61; 72 | — |
| SECONDARY Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD |
0; 54; 22; 67; 65; 70 | — |
| SECONDARY Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC) |
62; 68 | 0.78 |
| SECONDARY Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC) |
96; 100 | 0.48 |
| SECONDARY Number of Local Reactogenicity Events After First Dose |
19; 16 | 0.51 |
| SECONDARY Number of Local Reactogenicity Events After Second Dose |
11; 7 | 0.29 |
| SECONDARY Number of Systemic Reactogenicity Events After First Dose |
10; 7 | 0.43 |
| SECONDARY Number of Systemic Reactogenicity Events After Second Dose |
8; 3 | 0.11 |
| SECONDARY Comparison of Geometric Mean Titer (GMT) by HAI |
29; 50; 57; 40; 71; 67 | — |
| SECONDARY Comparison of Geometric Mean Ratios (GMR) by HAI |
4.0; 3.2; 10.2; 3.7; 5.2; 4.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
- Written informed consent (and assent, if applicable) obtained.
- Participant has a diagnosis of cancer or HIV.
- If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
Exclusion Criteria
- Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
- History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
- Not willing to agree to acceptable birth control for three months after study immunization
Data sourced from ClinicalTrials.gov (NCT01205581). 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.