Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine
1 other identifier
interventional
3,308
1 country
2
Brief Summary
The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Aug 2011
Typical duration for phase_4 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 1, 2013
CompletedMarch 28, 2013
March 1, 2013
3 months
December 20, 2012
March 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence rate of adverse events of the inactivated split influenza vaccine
two years
Secondary Outcomes (1)
Antibody titre of the inactivated split influenza vaccine
two years
Study Arms (2)
recombinant hepatitis b vaccine
PLACEBO COMPARATOR0.5ml intramuscular
Aleph influenza vaccine
EXPERIMENTAL0.5ml intramuscular
Interventions
0.5ml intramuscular
0.5ml intramuscular
Eligibility Criteria
You may qualify if:
- more than three years in good healthy
You may not qualify if:
- current infectious fever or acute disease
- upper respiratory infectious symptom within 6m
- a history of allergy
- laboratory confirmed influenza
- autoimmune disease
- have get influenza vaccine since 2008
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xinglong County Center for Disease Control and Prevention
Zhangjiakou, Hebei, China
Zhuolu County Center for Disease Control and Prevention
Zhangjiakou, Hebei, China
Related Publications (2)
Bai Y, Shi N, Lu Q, Yang L, Wang Z, Li L, Han H, Zheng D, Luo F, Zhang Z, Ai X. Immunological persistence of a seasonal influenza vaccine in people more than 3 years old. Hum Vaccin Immunother. 2015;11(7):1648-53. doi: 10.1080/21645515.2015.1037998.
PMID: 26083828DERIVEDLi S, Li L, Ai X, Yang L, Bai Y, Wang Z, Han H, Lu Q, Luo F, Zhang Z, Liu C, Xiao J, Shi N. A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people. Hum Vaccin Immunother. 2014;10(3):557-65. doi: 10.4161/hv.27329. Epub 2013 Dec 3.
PMID: 24301228DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nianmin Shi, Master
Beijing Chaoyang District Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
January 1, 2013
Study Start
August 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2012
Last Updated
March 28, 2013
Record last verified: 2013-03