Influenza, Human
Conditions
Keywords
Influenza Vaccines, Vaccines, Inactivated, Cell Culture-Derived
Brief summary
This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6\ 35 months.
Detailed description
Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.
Interventions
BIOLOGICALNBP607-QIV
For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]
BIOLOGICALNBP607-TIV
For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular \[\* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart\]
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Children aged 6 months to 35 months * Those who was born after normal pregnancy period(37 weeks) for aged 6 months to \< 1 year * Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.
Exclusion criteria
* Subjects with immune deficiency disorder or malignant cancer. * History of any hypersensitivity following administration of vaccine or Guillain-Barre syndrome. * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day. * 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 received any other investigational products within 4 weeks prior to study vaccination. * Subjects with clinically significant chronic disease. * Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70% | At Day 28 post-vaccination | Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40 |
| HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40% | At Day 28 post-vaccination | Seroconversion is defined as a pre-vaccination HI titer of \<1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer |
| HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5 | At Day 28 post-vaccination | GMR \[geometric mean ratio, mean fold increase\] |
Countries
South Korea
Outcome results
None listed