Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of NBP607 (Trivalent Inactivated Cell Culture-derived Influenza Vaccine) in Healthy Adults and Elderly Subjects

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.

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

To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: NBP607; Biological: Agrippal S1

Detailed Description

This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

• Study Type: Interventional
• Enrollment (Actual): 1155
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults aged 19 years or older.
• The subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements.
• If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period.

Exclusion Criteria:

• Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
• Subjects with immune deficiency disorder.
• History of Guillain-Barre syndrome.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection.
• Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
• Subjects who had received blood products or immunoglobulin within 3 months before screening.
• Subjects who had received influenza vaccination within 6 months prior to the screening.
• Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination.
• Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
• Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
• Subjects with clinically significant chronic disease or malignant cancer.
• Pregnant women, breast-feeding women.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

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: NBP607; cell culture-derived trivalent inactivated subunit influenza vaccine	Biological: NBP607; 0.5 mL, intramuscular, a single dose
Active Comparator: Agrippal S1; egg-derived trivalent inactivated subunit influenza vaccine	Biological: Agrippal S1; 0.5 mL, intramuscular, a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen	Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Post-Vaccination.; Percentage of Participants Achieving Seroconversion at Day 21 Post-Vaccination With Influenza Vaccine.; Pre- and Post- Vaccination Geometric Mean Ratio (GMR)	Day 0 and Day 21 post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80		Day 0 and Day 21 post-vaccination
Immunogenicity compared to control group		Day 21 post vaccination, 6 months post vaccination
Long-term Immunogenicity		6 months post-vaccination
Percentage of participants with Solicited Local Adverse Event (AE)		During 7 days post-vaccination
Percentage of participants with Solicited Systemic Adverse Event (AE)		During 7 days post-vaccination
Percentage of participants with Unsolicited Adverse Event (AE)		During 21 days post-vaccination
Percentage of participants with Severe Adverse Event (SAE)		During 6 months post-vaccination
Vital Sign	Body Temperature, Blood Pressure(SBP/DBP), Pulse	Day 0 and Day 21 post vaccination
Physical Examination	inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen)	Day 0 and Day 21 post vaccination
Clinical Laboratory Tests	Blood test(CBC, Coagulation, Chemistry), Urinalysis	Day 0 and Day 21 post vaccination

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Principal Investigator: Woojoo Kim, Korea University Guro Hospital; Principal Investigator: Seongheon Wie, Saint Vincent's Hospital, Korea; Principal Investigator: Shinwoo Kim, Kyungpook National University Hospital; Principal Investigator: Wonsuk Lee, Korea University Ansan Hospital; Principal Investigator: Jinsoo Lee, Inha University Hospital; Principal Investigator: Jacob Lee, Hallym University Kangnam Sacred Heart Hospital; Principal Investigator: Heungjeong Woo, Dotal Sacred Heart Hospital

Publications and helpful links

General Publications

• Song JY, Cheong HJ, Lee J, Woo HJ, Wie SH, Lee JS, Kim SW, Noh JY, Choi WS, Kim H, Kim KH, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607): A randomized, double-blind, multi-center, phase 3 clinical trial. Vaccine. 2015 Oct 5;33(41):5437-5444. doi: 10.1016/j.vaccine.2015.08.030. Epub 2015 Aug 24.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 24, 2014
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (Estimate): January 22, 2015

Study Record Updates

• Last Update Posted (Estimate): January 22, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: December 1, 2014

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: NBP607_FluA_III_2013