Clinical trial NCT02344134: Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 1155
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen
timeFrame: Day 0 and Day 21 post-vaccination
Secondary outcomes:
measure: Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80
timeFrame: Day 0 and Day 21 post-vaccination
measure: Immunogenicity compared to control group
timeFrame: Day 21 post vaccination, 6 months post vaccination
measure: Long-term Immunogenicity
timeFrame: 6 months post-vaccination
measure: Percentage of participants with Solicited Local Adverse Event (AE)
timeFrame: During 7 days post-vaccination
measure: Percentage of participants with Solicited Systemic Adverse Event (AE)
timeFrame: During 7 days post-vaccination
measure: Percentage of participants with Unsolicited Adverse Event (AE)
timeFrame: During 21 days post-vaccination
measure: Percentage of participants with Severe Adverse Event (SAE)
timeFrame: During 6 months post-vaccination
measure: Vital Sign
timeFrame: Day 0 and Day 21 post vaccination
measure: Physical Examination
timeFrame: Day 0 and Day 21 post vaccination
measure: Clinical Laboratory Tests
timeFrame: Day 0 and Day 21 post vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Guro Hospital
name: Woojoo Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Vincent's Hospital, Korea
name: Seongheon Wie
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Shinwoo Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Ansan Hospital
name: Wonsuk Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Jinsoo Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Jacob Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Dotal Sacred Heart Hospital
name: Heungjeong Woo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.