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Completed

NCT Number: NCT03826719

Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

NBP607QIV

Biological

Purified inactivated influenza virus surface antigens of four strains(quadrivalent)

Agrippal

Biological

Influenza virus surface antigens of three strains(trivalent)

Primary outcomes

  1. Incidence rate of solicited local adverse events(AEs)

    Time frame: 7 days after vaccination

    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.

  2. Incidence rate of solicited systemic AEs

    Time frame: 7 days after vaccination

    The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.

  3. Incidence rate of unsolicited AEs

    Time frame: 21 days after vaccination

    The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.

Secondary outcomes

  1. Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]

    Time frame: 21-28 days after vaccination

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

  2. Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]

    Time frame: 21-28 days after vaccination

    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

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

    Time frame: 21-28 days after vaccination

    The mean increase in geometric mean HI titer

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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