Phase 2
N=63
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010
Seasonal Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00956761 ↗Enrolled (actual)
63
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 — 43; 46; 43 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Seasonal Influenza Vaccine (MF59C.1) (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jun 2009
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 |
43; 46; 43 | — |
| PRIMARY Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
1.55; 1.53; 1.59 | — |
| PRIMARY Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD |
93; 93; 98 | — |
| PRIMARY Number of Participants Who Reported Solicited Local and Systemic Reactions |
2; 8; 3; 6; 9; 1 | — |
Summary
This is a trial for annual registration of the updated seasonal influenza vaccine formulation.
Eligibility Criteria
Key Inclusion Criteria
- Subjects 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 disease
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
- A proven hypersensitivity to any component of the study vaccine
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
- 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 12 months, participants had received more than one injection of influenza vaccine
- Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine
Data sourced from ClinicalTrials.gov (NCT00956761). 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.