Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT01640691|
Recruitment Status : Unknown
Verified July 2012 by Adimmune Corporation.
Recruitment status was: Recruiting
First Posted : July 16, 2012
Last Update Posted : July 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pandemic Influenza||Biological: Pandemic Influenza Vaccine (H5N1)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study to Evaluate the Immunogenicity and Safety of Pandemic Influenza Vaccine, AdimFlu-W (H5N1), in Healthy Adults|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||April 2013|
Biological: Pandemic Influenza Vaccine (H5N1)
- Administration route: Intramuscular Injection
- Dosing schedule: 2 injections - at Day 1 and Day 22 separately
- Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)
Inactivated whole-virion vaccine
- Immunogenicity Endpoint: hemagglutination inhibition (HAI) titer and microneutralization (MN) titer [ Time Frame: At Day 43 (21 days after the second dose). ]
The primary immune response endpoint is to evaluate the seroconversion rate (SCR) in terms of HAI assays at Day 43 (21 days after the second dose).The secondary HAI endpoints are defined as following:
- SCR for the first vaccination, at Day 22.
- Seroprotection rates (SPR) for each vaccination, at Day 22 and 43.
- The geometric mean fold rise (GMFR) for each vaccination, at Day 22 and 43.
The supportive immunogenicity endpoints of MN antibodies are SCRs, SPRs and GMFRs at Day 22 and 43.
- 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 after vaccination. [ Time Frame: At 4 weeks after two doses of study vaccine, 4 weeks apart. 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): NCT01640691
|Contact: Wendy Tsenfirstname.lastname@example.org|
|National Cheng Kung University Hospital||Recruiting|
|Principal Investigator:||Chih-Jen Chang, MD||National Cheng-Kung University Hospital|