Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

Prevention of Influenza Clinical Trial

Official title:

Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893669
• Other study ID #: NBP607_Flu_I_2012
• Status: Completed
• Phase: Phase 1
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: SK Chemicals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

Description:

1. Assessment of Safety

2. Assessment of Immunogenicity

3. Estimated Enrollment: 100

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

Inclusion Criteria:

1. 20 to <60 years of age

2. able and willing to give written informed consent prior to study entry

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

2. Immunodeficiency disease

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

4. thrombocytopenia or Coagulation disorders

5. experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection

6. receipt of Immunosuppressants or Immunomodulators within the past 3 months

7. receipt of blood products or immunoglobulin within the past 3 months

8. received influenza vaccine within the past 6 months

9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination

10. participation on another clinical trial within 1 month prior to the study vaccination

11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination

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

13. pregnant or breastfeeding

14. 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, Human
• Prevention of Influenza

Intervention

Biological:
• NBP607
1 dose, 0.5ml, Intramuscular (IM) injection
• Agrippal
1 dose, 0.5ml, Intramuscular (IM) injection

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro-gu

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

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.	Within 21 days after vaccination
Primary	Incidence rate of solicited systemic 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.	Within 21 days after vaccination
Primary	Incidence rate of unsolicited 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.	Within 21 days after vaccination
Primary	Pulse rate at each visit	Comparisons within each group between pre-/post- vaccination were summarized and presented.	0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Primary	Blood pressure(systolic/diastolic) at each visit	Comparisons within each group between pre-/post- vaccination were summarized and presented.	0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Primary	Body temperature at each visit	Comparisons within each group between pre-/post- vaccination were summarized and presented.	0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Primary	Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit	Comparisons within each group between pre-/post- vaccination were summarized and presented.	Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Primary	Rate of normal/abnormal results in physical examination at each visit	Comparisons within each group between pre-/post- vaccination were summarized and presented.	0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Primary	Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit	Comparisons within each group between pre-/post- vaccination were summarized and presented.	Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Secondary	Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]	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	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
Secondary	Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]	The proportion of subjects with post-vaccination HI titers of =1:40	21-28 days after vaccination