Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Influenza
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 6 years and 125 years
- Gender
- Both males and females
Description
The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of t...
The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively. Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.
Tracking Information
- NCT #
- NCT01554813
- Collaborators
- Not Provided
- Investigators
- Study Director: Feng-cai Zhu, M.D. Jiangsu Provicial Center for Disease Provention and Control
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