Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

SK chemicals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Influenza

Treatments

Biological: Agrippal

Biological: NBP607QIV

Study type

Interventional

Funder types

Industry

Identifiers

NCT03826719

NBP607QIV_Flu_I_2013

Details and patient eligibility

About

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Full 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 post-vaccination are assessed and reported. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.

Enrollment

100 patients

Sex

All

Ages

19 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.