Clinical trial NCT02467842: Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects
Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza vaccine
Quadrivalent
Inactivated cell culture-derived
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-10
Enrollment: 1503
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: All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.

Detailed description: In a randomized controlled phase III trial undertaken in 10 university hospitals of South Korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine (TIV), NBP607-Y and NBP607-V. Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (HI) assay. Safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (AEs) for 21 days and serious adverse events (SAE) for 6 months.

Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years and older
* Those who are able to comply with the requirements for the study
* If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Exclusion Criteria:

* Disorders in immune function
* Any malignancy or lymphoproliferative disorder
* History of Guillain-Barré syndrome
* Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
* Experience of fever (\>38.0 ℃) within 24 hours following vaccination
* Body temperature \>38.0 ℃ at the vaccination day
* Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months
* Influenza vaccination within 6 months
* Subjects who have participated in other interventional study within 4 weeks
* Any vaccination within 1 month
* Those who are planning to receive any vaccine within 1 month from the study vaccine
* Individuals with any serious chronic or progressive disease
* Pregnant or breast-feeding women
* Any other reason that in the opinion of the investigator might interfere with the study

Primary outcomes:
measure: Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
timeFrame: At Day 21 post vaccination.
measure: Seroconversion Rate (SCR) After Vaccination in All Subjects
timeFrame: At Day 21 post vaccination.
measure: Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
timeFrame: At Day 21 post vaccination.
measure: Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
timeFrame: At Day 21 post vaccination.
measure: Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
timeFrame: At Day 21 post vaccination.
Secondary outcomes:
measure: Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects
timeFrame: At Day 21 post vaccination.
measure: Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects
timeFrame: At Day 21 post vaccination.
measure: Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
timeFrame: At Day 21 post vaccination.
measure: Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
timeFrame: At Day 21 post vaccination.
measure: Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
timeFrame: At Day 21 post vaccination.
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, MD, PhD
role: STUDY_CHAIR
affiliation: Korea University
name: Won Suk Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University St. Vincent's Hospital
name: Seong-Heon Wie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Jin Soo Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Jacob Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook University Hospital
name: Shin Woo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk University Hospital
name: Hye Won Jeong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam University Hospital
name: Sook-In Jung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam University Hospital
name: Yeon-Sook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Dongtan Sacred Heart Hospital
name: Heung Jeong Woo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi WS, Noh JY, Song JY, Cheong HJ, Wie SH, Lee JS, Lee J, Kim SW, Jeong HW, Jung SI, Kim YS, Woo HJ, Kim KH, Kim H, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. Hum Vaccin Immunother. 2017 Jul 3;13(7):1653-1660. doi: 10.1080/21645515.2017.1297351. Epub 2017 Apr 13.