Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: NBP607QIV; Biological: Agrippal

• Registration Number: NCT03826719
• Lead Sponsor: SK Chemicals Co., Ltd.

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.

Study Timeline

• Study Start: 2014-02-17
• Primary Completion: 2014-03-28
• Study Completion: 2014-03-28
• Status Verified: 2019-01
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBP607QIV	NBP607QIV	1 dose of 0.5mL by Intramuscular injection
Agrippal	Agrippal	1 dose of 0.5mL by Intramuscular injection

Primary Outcome Measures

Name	Time	Method
Incidence rate of solicited local adverse events(AEs)	7 days after vaccination	All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.; Comparisons within each group between pre-/post- vaccination were summarized and presented.; The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Incidence rate of solicited systemic AEs	7 days after vaccination	The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Incidence rate of unsolicited AEs	21 days after vaccination	The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.

Secondary Outcome Measures

Name	Time	Method
9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]	21-28 days after vaccination	The mean increase in geometric mean HI titer
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]	21-28 days after vaccination	The proportion of subjects with post-vaccination HI titers of ≥1:40
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]	21-28 days after vaccination	The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were \<1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer