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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,503
- 主要终点
- Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
时间窗: At Day 21 post vaccination.
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).
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
时间窗: At Day 21 post vaccination.
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.
Seroconversion Rate (SCR) After Vaccination in All Subjects
时间窗: At Day 21 post vaccination.
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).
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
时间窗: At Day 21 post vaccination.
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
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
时间窗: At Day 21 post vaccination.
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.
次要结局
- Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years(At Day 21 post vaccination.)
- 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.)
- Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years(At Day 21 post vaccination.)
- Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years(At Day 21 post vaccination.)