Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: NBP607QIV; Biological: Agrippal

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NBP607QIV; 1 dose of 0.5mL by Intramuscular injection	Biological: NBP607QIV; Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
Active Comparator: Agrippal; 1 dose of 0.5mL by Intramuscular injection	Biological: Agrippal; Influenza virus surface antigens of three strains(trivalent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of solicited local adverse events(AEs)	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.	7 days after vaccination
Incidence rate of solicited systemic AEs	The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.	7 days after vaccination
Incidence rate of unsolicited AEs	The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.	21 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]	The proportion of subjects with post-vaccination HI titers of ≥1:40	21-28 days after vaccination
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]	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	21-28 days after vaccination
9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]	The mean increase in geometric mean HI titer	21-28 days after vaccination

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2014
• Primary Completion (Actual): March 28, 2014
• Study Completion (Actual): March 28, 2014

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: NBP607QIV_Flu_I_2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No