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

SK Chemicals Co., Ltd.100 enrolled

Overview

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

1. Assessment of Safety 2. Assessment of Immunogenicity 3. Estimated Enrollment: 100

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Prevention of Influenza

Interventions

NBP607BIOLOGICAL

1 dose, 0.5ml, Intramuscular (IM) injection

AgrippalBIOLOGICAL

1 dose, 0.5ml, Intramuscular (IM) injection

Eligibility

Sex: ALLMin age: 20 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Within 21 days after vaccination

Incidence rate of solicited systemic AEs

Time frame: Within 21 days after vaccination

Incidence rate of unsolicited AEs

Time frame: Within 21 days after vaccination

Pulse rate at each visit

Comparisons within each group between pre-/post- vaccination were summarized and presented.

Time frame: 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.

Time frame: 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.

Time frame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 21-28 days after vaccination

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

The mean increase in geometric mean HI titer

Time frame: 21-28 days after vaccination

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

The proportion of subjects with post-vaccination HI titers of ≥1:40

Time frame: 21-28 days after vaccination