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

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

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.

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.

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