Influenza, Human Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children and Adolescents Aged 6 Months ~ 18 Years
Verified date | December 2015 |
Source | SK Chemicals Co.,Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 454 |
Est. completion date | June 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SK Chemicals Co.,Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CHMP criteria | Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5 | At Day 28 post-vaccination | No |
Secondary | Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80 | At Day 28 post-vaccination | No | |
Secondary | Immunogenicity compared to control group | At Day 28 post-vaccination | No | |
Secondary | Incidence rate of Advers Event (AE) | Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE | During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE | Yes |
Secondary | Incidence rate of Severe Adverse Event (SAE) | During 6 months post-vaccination | Yes | |
Secondary | Vital Sign | At Day 0 and at Day 28 post-vaccination | Yes | |
Secondary | Physical Examination | At Day 0 and at Day 28 post-vaccination | Yes |
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