Clinical trial NCT03826719: Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
Official title: A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged 19 to 59 years
2. 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
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. Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
2. Those with Immunodeficiency disease
3. Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
4. Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
5. Those who experienced fever (\>38°C) within the past 24 hours or any acute respiratory infection
6. Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
7. Those with history of receiving blood products or immunoglobulin within the past 3 months
8. Those with history of influenza vaccination within the past 6 months
9. Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
10. Those with history of participation on another clinical trial within 1 month prior to the study vaccination
11. 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
12. Those with any chronic diseases that interfere with the clinical trial or malignant tumors
13. Pregnant or breastfeeding
14. 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.

Primary outcomes:
measure: Incidence rate of solicited local adverse events(AEs)
timeFrame: 7 days after vaccination
measure: Incidence rate of solicited systemic AEs
timeFrame: 7 days after vaccination
measure: Incidence rate of unsolicited AEs
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
timeFrame: 21-28 days after vaccination
measure: Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
timeFrame: 21-28 days after vaccination
measure: 9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
timeFrame: 21-28 days after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, MD, PhD
role: STUDY_CHAIR
References: