Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

NCT02467842 | Completed Phase 3 Results

• 1 other identifier: NBP607-QIV_FluA_III_2014
• Study Type: interventional
• Target: 1,503
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

Influenza vaccine; Quadrivalent; Inactivated cell culture-derived

Outcome Measures

Primary Outcomes (5)

• Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects

  GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V). For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV).

  At Day 21 post vaccination.

• Seroconversion Rate (SCR) After Vaccination in All Subjects

  SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of \<1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV).

  At Day 21 post vaccination.

• Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

  SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

  At Day 21 post vaccination.

• Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

  SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of \<1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

  At Day 21 post vaccination.

• Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

  GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination.

  At Day 21 post vaccination.

Secondary Outcomes (5)

• Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects

  At Day 21 post vaccination.

• Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects

  At Day 21 post vaccination.

• Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years

  At Day 21 post vaccination.

• Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years

  At Day 21 post vaccination.

• Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years

  At Day 21 post vaccination.

Study Arms (3)

NBP607-QIV

EXPERIMENTAL

Participants aged 19 years and older received a 0.5mL single intramuscular dose of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria on Day 0

Biological: NBP607-QIV

NBP607-Y

ACTIVE COMPARATOR

Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata on Day 0

Biological: NBP607-Y

NBP607-V

ACTIVE COMPARATOR

Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria on Day 0

Biological: NBP607-V

Interventions

NBP607-QIV BIOLOGICAL

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria

NBP607-QIV

NBP607-Y BIOLOGICAL

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata

NBP607-Y

NBP607-V BIOLOGICAL

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria

NBP607-V

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 28406746 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Hayoung Lee
• Organization: SK bioscience

haylee@sk.com

+82-2-2008-2552

Study Officials

• Woo Joo Kim, MD, PhD

  Korea University Guro Hospital

  STUDY CHAIR

• Won Suk Choi, MD, PhD

  Korea University

  PRINCIPAL INVESTIGATOR

• Seong-Heon Wie, MD, PhD

  Catholic University St. Vincent's Hospital

  PRINCIPAL INVESTIGATOR

• Jin Soo Lee, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Jacob Lee, MD, PhD

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

• Shin Woo Kim, MD, PhD

  Kyungpook University Hospital

  PRINCIPAL INVESTIGATOR

• Hye Won Jeong, MD

  Chungbuk University Hospital

  PRINCIPAL INVESTIGATOR

• Sook-In Jung, MD

  Chonnam University Hospital

  PRINCIPAL INVESTIGATOR

• Yeon-Sook Kim, MD, PhD

  Chungnam University Hospital

  PRINCIPAL INVESTIGATOR

• Heung Jeong Woo, MD, PhD

  Hallym University Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 10, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 8, 2020
• Results First Posted: May 8, 2020

Record last verified: 2015-06