Status:
COMPLETED
Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Influenza
Eligibility:
All Genders
19-59 years
Phase:
PHASE1
PHASE2
Brief Summary
This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
Detailed Description
Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days pos...
Eligibility Criteria
Inclusion
- Healthy adults aged 19 to 59 years
- Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
- If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion
- Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Those with Immunodeficiency disease
- Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
- Those who experienced fever (\>38°C) within the past 24 hours or any acute respiratory infection
- Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
- Those with history of receiving blood products or immunoglobulin within the past 3 months
- Those with history of influenza vaccination within the past 6 months
- Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
- Those with history of participation on another clinical trial within 1 month prior to the study vaccination
- Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
- Those with any chronic diseases that interfere with the clinical trial or malignant tumors
- Pregnant or breastfeeding
- Those with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
Key Trial Info
Start Date :
February 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03826719
Start Date
February 17 2014
End Date
March 28 2014
Last Update
February 1 2019
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