Influenza, Human
Conditions
Brief summary
This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.
Detailed description
Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. 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 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
BIOLOGICALAgrippal S1
For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
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 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children and adolescents aged 6 months to 18 years. * 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 who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products. * Subjects with immune deficiency disorder or malignant cancer. * History of 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 participated in other clinical trial within 4 weeks prior to study vaccination. * Subjects with clinically significant chronic disease. * Pregnant women, breast-feeding women. * 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 |
|---|---|---|
| CHMP criteria | At Day 28 post-vaccination | Seroprotection rate \> 70%, Seroconversion rate \> 40%, GMR \> 2.5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity compared to control group | At Day 28 post-vaccination | — |
| Incidence rate of Advers Event (AE) | During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE | Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE |
| Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80 | At Day 28 post-vaccination | — |
| Vital Sign | At Day 0 and at Day 28 post-vaccination | — |
| Physical Examination | At Day 0 and at Day 28 post-vaccination | — |
| Incidence rate of Severe Adverse Event (SAE) | During 6 months post-vaccination | — |
Outcome results
None listed