Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Prevention of Influenza

Treatments: Biological: Agrippal; Biological: NBP607

Study type: Interventional

Funder types: Industry

Identifiers

NCT03893669

NBP607_Flu_I_2012

Details and patient eligibility

About

A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

Full description

1. Assessment of Safety
2. Assessment of Immunogenicity
3. Estimated Enrollment: 100

Enrollment: 100 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 20 to <60 years of age
2. able and willing to give written informed consent prior to study entry
3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion criteria

1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
2. Immunodeficiency disease
3. history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
4. thrombocytopenia or Coagulation disorders
5. experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
6. receipt of Immunosuppressants or Immunomodulators within the past 3 months
7. receipt of blood products or immunoglobulin within the past 3 months
8. received influenza vaccine within the past 6 months
9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
10. participation on another clinical trial within 1 month prior to the study vaccination
11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
12. any chronic diseases that interfere with the clinical trial or Malignant tumors
13. pregnant or breastfeeding
14. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Group 1

Experimental group

Description:

NBP607 0.5ml

Treatment:

Biological: NBP607

Group 2

Active Comparator group

Description:

Agrippal 0.5ml

Treatment:

Biological: Agrippal