Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Influenza
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 636 years
- Gender
- Both males and females
Description
The clinical trial was designed randomized and double-blind. Participants included up to 810 persons (540 persons in test group and 270 persons in control group). Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the informed consent. Subjects were selected ac...
The clinical trial was designed randomized and double-blind. Participants included up to 810 persons (540 persons in test group and 270 persons in control group). Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the informed consent. Subjects were selected according to the inclusion and exclusion criteria. Every subject accepted 30min's observation in the hospital after vaccination and received periodic follow-up till the fourth week after the boost vaccination. Blood of subjects was collected at the third week after the boost vaccination for the analysis of the immunogenicity. During the test, the adverse reactions and detailed information were reported to the SFDA under the status of blinding every month. Unblinding was conducted after the completion of the follow-up of subjects.
Tracking Information
- NCT #
- NCT01554826
- Collaborators
- Not Provided
- Investigators
- Study Director: Feng-cai Zhu, M.D. Jiangsu Provincial Center for Disease Prevention and Control
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