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

SK Chemicals Co., Ltd.1,503 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,503

Conditions

Influenza

Interventions

NBP607-QIVBIOLOGICAL

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

NBP607-YBIOLOGICAL

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

NBP607-VBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).