Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826719
• Other study ID #: NBP607QIV_Flu_I_2013
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 17, 2014
• Est. completion date: March 28, 2014

Study information

• Verified date: January 2019
• Source: SK Chemicals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Description:

Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. 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. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 28, 2014
• Est. primary completion date: March 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 59 Years

Eligibility

Inclusion Criteria:

1. Healthy adults aged 19 to 59 years

2. 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

3. If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion Criteria:

1. Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products

2. Those with Immunodeficiency disease

3. Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome

4. Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy

5. Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection

6. Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months

7. Those with history of receiving blood products or immunoglobulin within the past 3 months

8. Those with history of influenza vaccination within the past 6 months

9. Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination

10. Those with history of participation on another clinical trial within 1 month prior to the study vaccination

11. 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

12. Those with any chronic diseases that interfere with the clinical trial or malignant tumors

13. Pregnant or breastfeeding

14. 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• NBP607QIV
Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
• Agrippal
Influenza virus surface antigens of three strains(trivalent)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]	The proportion of subjects with post-vaccination HI titers of =1:40	21-28 days after vaccination
Secondary	Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]	The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer =1:40 after vaccination ii)If the pre-vaccination HI titers were =1:10, subjects with a minimum 4-fold rise in HI titer	21-28 days after vaccination
Secondary	9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]	The mean increase in geometric mean HI titer	21-28 days after vaccination