Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008
Phase 3
Completed
- Conditions
- Seasonal InfluenzaVaccine
- Registration Number
- NCT00498303
- Lead Sponsor
- Novartis
- Brief Summary
Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- available for all the visits scheduled in the study and able to comply with all study requirements
- in good health as determined by: medical history, physical examination, clinical judgment of the investigator
Exclusion Criteria
- n/a
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21 evaluate safety of trivalent split influenza vaccine
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of trivalent split influenza vaccines in eliciting immune responses in elderly populations?
How does the 2007/2008 strain composition of NCT00498303 compare to standard-of-care vaccines in terms of immunogenicity and safety profiles?
Which biomarkers correlate with enhanced antibody titers following administration of preservative-free inactivated influenza vaccines in adults and elderly subjects?
What adverse events were observed in Phase III trials of Novartis' trivalent split influenza vaccine and how were they managed?
Are there combination approaches or competitor vaccines targeting seasonal influenza strains similar to the 2007/2008 composition in adult and elderly populations?
Trial Locations
- Locations (1)
Werksarztzentrum Herborn
🇩🇪Herborn, Germany