Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents
- Conditions
- Influenza, Human
- Interventions
- Biological: NBP607Biological: Agrippal S1
- Registration Number
- NCT02621177
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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 trivalent 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 385
- Healthy children and adolescents aged 6 months to 18 years.
- Those who was born after normal pregnancy period(37 weeks) for aged 6 months to 2 years.
- Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.
- Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
- Subjects with immune deficiency disorder.
- 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 or with any acute respiratory infection.
- 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 who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
- Subjects with clinically significant chronic disease or malignant cancer.
- Pregnant women, breast-feeding women.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NBP607 NBP607 Trivalent Inactivated Cell Culture-derived Influenza Vaccine Agrippal S1 Agrippal S1 Trivalent Inactivated Egg-derived Influenza Vaccine
- Primary Outcome Measures
Name Time Method CHMP criteria At Day 28 post-vaccination Seroprotection rate \> 70%, Seroconversion rate \> 40%, GMR \> 2.5
- Secondary Outcome Measures
Name Time Method Immunogenicity compared to control group At Day 28 post-vaccination Vital Sign At Day 0 and at Day 28 post-vaccination Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80 At Day 28 post-vaccination Incidence rate of Severe Adverse Event (SAE) During 6 months post-vaccination Physical Examination At Day 0 and 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