- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03704740
Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months
A Multinational, Comparative Phase III Clinical Trial to Assess the Efficacy (Immunogenicity) and Safety of NBP607-QIV (0.5 mL) (Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine) in Children Aged 6 to 35 Months
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated for active immunization for the the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled. Each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio.
Stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment.
Total of three or five visits are scheduled depeding on dosing schedule. For subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety is monitored 3 days, 4 weeks after vaccination through Visit 2* and 3 (* telephone contact). For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively. Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2*, 3, 4*, and 5 (* telephone contact)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Seongnam-si
-
Gyeonggi-do, Seongnam-si, Korea, Republic of, 13494
- SK Bioscience
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged 6 to 35 months
- Those who were normal gestational age at birth (for children aged 6 months to <1 year)
- Those who have provided written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
Exclusion Criteria:
- Those with any immunodeficiency disease or malignancy
- Those with hypersensitivity to vaccination
- Those who are contraindicated for intramuscular injection due to thrombocytopenia or other coagulopathy
- Those with history of treatment with any of immunosuppressants or immunoregulators within 12 weeks prior to screening
- Those with history of receiving blood product or treatment with immunoglobulin within 24 weeks prior to screening
- Those with history of influenza vaccination within 24 weeks prior to screening
- Those with any severe chronic conditions that interfere with study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NBP607-QIV
One or two doses of 0.5mL of NBP607-QIV by intramuscular injection
|
Purified inactivated influenza virus surface antigens of four strains (quadrivalent)
|
Active Comparator: Agrippal
One or two doses of 0.25mL of Agrippal by intramuscular injection
|
Influenza virus surface antigens of three strains (trivalent)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-vaccination GMT(Geometric Mean Titer) by HI(Hemagglutination-inhibition) assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Post-vaccination GMT will be adjusted for pre-vaccination titer
|
4 weeks after last IP(Investigational Product) vaccination
|
Seroconversion rate by HI assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:
|
4 weeks after last IP(Investigational Product) vaccination
|
Seroconversion rate by HI assay for the exclusive strain (B/Yamagata)
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:
|
4 weeks after last IP(Investigational Product) vaccination
|
GMR(Geometric mean ratio) by HI assay for the exclusive strain (B/Yamagata)
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
The fold-rise of the geometric mean HI titer from pre- to post-vaccination
|
4 weeks after last IP(Investigational Product) vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprotection rate by HI assay for all strains
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Seroprotection rate is defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40
|
4 weeks after last IP(Investigational Product) vaccination
|
CHMP(Committee for Medicinal Products for Human Use) criteria assessment for the common strains (A/H1N1, A/H3N2, and B/Victoria)
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
CHMP criteria for seroconversion rate, GMR(Geometric Mean Ratio) will be assessed
|
4 weeks after last IP(Investigational Product) vaccination
|
Consistency of immunogenicity among countries
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Post-vaccination GMT and seroconversion rate for the common strains (A/H1N1, A/H3N2, and B/Victoria), and CHMP criteria for seroconversion rate and GMR for the exclusive strain (B/Yamagata) will be assessed
|
4 weeks after last IP(Investigational Product) vaccination
|
Percentage of participants with Adverse Events(AEs)
Time Frame: 7 days for Solicited AE and 4 weeks for Unsolicited AE, SAE after last IP(Investigational Product) vaccination
|
Incidence rate of Solicited AE, unsolicited AE, SAE(Serious Adverse Event) will be assessed
|
7 days for Solicited AE and 4 weeks for Unsolicited AE, SAE after last IP(Investigational Product) vaccination
|
Vital sign
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Body temperature will be assessed
|
4 weeks after last IP(Investigational Product) vaccination
|
Height
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Height in centimeters will be assessed
|
4 weeks after last IP(Investigational Product) vaccination
|
Weight
Time Frame: 4 weeks after last IP(Investigational Product) vaccination
|
Weight in kilograms will be assessed
|
4 weeks after last IP(Investigational Product) vaccination
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yun Kyung Kim, MD, Korea University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBP607-QIV_005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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