Post-License Safety Evaluation of Influenza Virus Vaccine
Phase 4 Study of Post-License Safety Evaluation of Influenza Split Vaccine
1 other identifier
observational
400,000
0 countries
N/A
Brief Summary
To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun Institute of Biological Products Co.,Ltd.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedMay 12, 2014
May 1, 2014
11 months
May 8, 2014
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurence rate of adverse reaction
the general or local reactions are reported after vaccination .
1 month after vaccination
Study Arms (1)
Changchun biologial's vaccine
Changchun Biological's vaccine group is the population injected with this vaccine.
Eligibility Criteria
all the people immunized by influenza vaccine of Changchun Institute of Biological Product in Sichuan province in 2013.
You may qualify if:
- ever vaccinated one dose influenza vaccine(manufactured by Changchun institute of biological product) in 2013
- above 3 years old
You may not qualify if:
- Severe allergic reaction (e.g., anaphylaxis) after previous dose of any IIV or LAIV
- allergic to a vaccine component, including egg protein.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rui ao, master
Sichuan CDC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2014
First Posted
May 12, 2014
Study Start
January 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 12, 2014
Record last verified: 2014-05