Phase 2
N=64
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009
Interpandemic Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00734734 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: 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 — 38; 55; 42 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Seasonal Influenza Vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jul 2008
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 |
38; 55; 42 | — |
| PRIMARY Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
1.87; 3.74; 2.38 | — |
| PRIMARY Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
89; 75; 80 | — |
| PRIMARY Number of Participants Who Reported Solicited Local and Systemic Reactions |
0; 10; 2; 0; 11; 0 | — |
Summary
Trial for annual approval of interpandemic influenza vaccines
Eligibility Criteria
Key Inclusion Criteria
- 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, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
- Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
- A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- Within the past 12 months, they have received more than one injection of influenza vaccine
- Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
- Within the past 4 weeks participants had received another vaccine; any investigational agent
- An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days
Data sourced from ClinicalTrials.gov (NCT00734734). 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.