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

NCT02344134 | Completed Phase 3 DMC

• 1 other identifier: NBP607_FluA_III_2013
• Study Type: interventional
• Target: 1,155
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

NBP607

EXPERIMENTAL

cell culture-derived trivalent inactivated subunit influenza vaccine

Biological: NBP607

Agrippal S1

ACTIVE COMPARATOR

egg-derived trivalent inactivated subunit influenza vaccine

Biological: Agrippal S1

Interventions

NBP607 BIOLOGICAL

0.5 mL, intramuscular, a single dose

NBP607

Agrippal S1 BIOLOGICAL

0.5 mL, intramuscular, a single dose

Agrippal S1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 26314625 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

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: December 24, 2014
• First Posted: January 22, 2015
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2014-12