Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2014
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2014
CompletedFirst Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedFebruary 1, 2019
January 1, 2019
1 month
January 31, 2019
January 31, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence rate of solicited local adverse events(AEs)
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
7 days after vaccination
Incidence rate of solicited systemic AEs
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
7 days after vaccination
Incidence rate of unsolicited AEs
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
21 days after vaccination
Secondary Outcomes (3)
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
21-28 days after vaccination
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
21-28 days after vaccination
9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
21-28 days after vaccination
Study Arms (2)
NBP607QIV
EXPERIMENTAL1 dose of 0.5mL by Intramuscular injection
Agrippal
ACTIVE COMPARATOR1 dose of 0.5mL by Intramuscular injection
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults aged 19 to 59 years
- Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
- If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
You may not qualify if:
- Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Those with Immunodeficiency disease
- Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
- Those who experienced fever (\>38°C) within the past 24 hours or any acute respiratory infection
- Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
- Those with history of receiving blood products or immunoglobulin within the past 3 months
- Those with history of influenza vaccination within the past 6 months
- Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
- Those with history of participation on another clinical trial within 1 month prior to the study vaccination
- Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
- Those with any chronic diseases that interfere with the clinical trial or malignant tumors
- Pregnant or breastfeeding
- Those with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Woo Joo Kim, MD, PhD
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 1, 2019
Study Start
February 17, 2014
Primary Completion
March 28, 2014
Study Completion
March 28, 2014
Last Updated
February 1, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share