Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
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|ClinicalTrials.gov Identifier: NCT01355172|
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : July 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: AdimFlu-S||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old|
|Study Start Date :||November 2010|
|Primary Completion Date :||September 2011|
- HA antibody titers will be determined using the WHO HAI reference technique. [ Time Frame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination. ]
- The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation. [ Time Frame: (4 weeks after two doses of study vaccine, 4 weeks apart), Physical examination will be performed at each visit. Reactogenicity will be recorded for 7 days after each vaccination. ]
Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.
The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
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): NCT01355172
|China Medicine University Hospital|
|Taichung, Taiwan, 404|