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

NCT03893669 | Completed Phase 1 DMC

• 1 other identifier: NBP607_Flu_I_2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Prevention of Influenza

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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)

• 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

• 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 Outcomes (3)

• Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]

  21-28 days after vaccination

• Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]

  21-28 days after vaccination

• Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]

  21-28 days after vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

NBP607 0.5ml

Biological: NBP607

Group 2

ACTIVE COMPARATOR

Agrippal 0.5ml

Biological: Agrippal

Interventions

NBP607 BIOLOGICAL

1 dose, 0.5ml, Intramuscular (IM) injection

Group 1

Agrippal BIOLOGICAL

1 dose, 0.5ml, Intramuscular (IM) injection

Group 2

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to \<60 years of age
• able and willing to give written informed consent prior to study entry
• 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:

• hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
• Immunodeficiency disease
• history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
• thrombocytopenia or Coagulation disorders
• experienced fever (\>37.5°C) within the past 24 hours or any acute respiratory infection
• receipt of Immunosuppressants or Immunomodulators within the past 3 months
• receipt of blood products or immunoglobulin within the past 3 months
• received influenza vaccine within the past 6 months
• received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
• participation on another clinical trial within 1 month prior to the study vaccination
• history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
• any chronic diseases that interfere with the clinical trial or Malignant tumors
• pregnant or breastfeeding
• 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.

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 153-703, South Korea

Location

Study Officials

• Woo Joo Kim, Ph.D.

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

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: December 12, 2012
• First Posted: March 28, 2019
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 28, 2019

Record last verified: 2012-10

Locations

KR (1)