Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China
Phase 3
Completed
- Conditions
- Healthy
- Registration Number
- NCT00325260
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
- signed and dated informed consent
- being healthy
- mental health enough to understand the study, the informed consent form and the questionnaire
Exclusion Criteria
- known to be allergic to constituents of the vaccine
- having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
- having had a documented serious adverse reaction to previous influenza vaccination
- having had documented influenza infection or vaccination in the six months prior to the start of the study
- having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HI titers 4 weeks after vaccination (efficacy) and safety and tolerability
- Secondary Outcome Measures
Name Time Method HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination
Trial Locations
- Locations (1)
Site 1
🇨🇳Nanjing, China