Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
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|ClinicalTrials.gov Identifier: NCT01752881|
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Influenza vaccine (split virion, inactivated) Biological: AdimFlu-S||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Biological: Influenza vaccine (split virion, inactivated)
AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013
Dosage: 0.5mL/per syringe
Administration route: Intramuscular Injection, once
Other Name: AdimFlu-S Influenza VaccineBiological: AdimFlu-S
- Immunogenicity endpoint: Seroprotection rate [ Time Frame: At 3 weeks after vaccination ]Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
- Immunogenicity endpoint: Seroconversion rate [ Time Frame: At 3 weeks after vaccination ]The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer < 1:10.
- Immunogenicity endpoint: Geometric mean folds increase in HAI titer [ Time Frame: At 3 weeks after vaccination ]
- Safety: Reactogenicity events [ Time Frame: 7 days after vaccination ]Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection including fever (≥38°C), runny nose or nasal congestion, cough, sore throat, headache, muscle aches, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions will also be evaluated that include soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
- Safety: Serious and non-serious adverse events [ Time Frame: Through day 21 post vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752881
|National Cheng Kung University Hospital|
|Principal Investigator:||Chih-Jen Chang, MD||National Cheng-Kung University Hospital|