Phase 2
Completed N=63
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
Source: ClinicalTrials.gov NCT01344057 ↗Enrolled (actual)
63
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 — 69; 50; 26 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 |
69; 50; 26 | — |
| PRIMARY Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
2.54; 1.9; 1.36 | — |
| PRIMARY Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
89; 69; 94 | — |
| SECONDARY Number of Participants Who Reported Solicited Local and Systemic Reactions |
3; 7; 4; 7; 21; 4 | — |
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.
- Individuals able to comply with all the study requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.
Key Exclusion Criteria
- Individuals with any serious chronic or acute disease.
- Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.
- Individuals with known or suspected impairment/alteration of immune function.
- Individuals with known or suspected history of drug or alcohol abuse.
- Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
- Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.
- Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
- Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
- Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- 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.
- Individuals who are part of study personnel or close family members conducting this study.
- BMI > 35 kg/m2.
Data sourced from ClinicalTrials.gov (NCT01344057). 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.