Phase 2
Completed N=64
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011
Source: ClinicalTrials.gov NCT01152814 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD — 45; 61; 27 Percentage of participants
Summary
This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD |
45; 61; 27 | — |
| PRIMARY Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
1.96; 1.88; 1.32 | — |
| PRIMARY Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
97; 71; 100 | — |
| SECONDARY Number of Participants Who Reported Solicited Local and Systemic Reactions |
2; 4; 2; 0; 15; 2 | — |
Eligibility Criteria
Key Inclusion Criteria
- Males and females volunteers of 65 years of age or older
- Mentally competent
- Willing and able to give written informed consent prior to study entry.
- Able to comply with all the study requirements.
- In general good health
Key Exclusion Criteria
- Any serious chronic or acute disease
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
- Known or suspected impairment/alteration of immune function
- Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
- Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
Data sourced from ClinicalTrials.gov (NCT01152814). 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.