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

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: NBP607-Y; Biological: NBP607-QIV; Biological: NBP607-V

Study type: Interventional

Funder types: Industry

Identifiers

NCT02467842

NBP607-QIV_FluA_III_2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,503 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,503 participants in 3 patient groups

NBP607-QIV

Experimental group

Description:

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

Treatment:

Biological: NBP607-QIV

NBP607-Y

Active Comparator group

Description:

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

Treatment:

Biological: NBP607-Y

NBP607-V

Active Comparator group

Description:

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

Treatment:

Biological: NBP607-V