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Completed

NCT Number: NCT02344134

Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.

To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.

To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 19 years or older.
  • The subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements.
  • If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period.

Exclusion criteria

  • Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
  • Subjects with immune deficiency disorder.
  • History of Guillain-Barre syndrome.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection.
  • Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
  • Subjects who had received blood products or immunoglobulin within 3 months before screening.
  • Subjects who had received influenza vaccination within 6 months prior to the screening.
  • Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination.
  • Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
  • Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
  • Subjects with clinically significant chronic disease or malignant cancer.
  • Pregnant women, breast-feeding women.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Treatment and study plan

NBP607

Biological

0.5 mL, intramuscular, a single dose

Agrippal S1

Biological

0.5 mL, intramuscular, a single dose

Primary outcomes

  1. Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen

    Time frame: Day 0 and Day 21 post-vaccination

    • Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Post-Vaccination.
    • Percentage of Participants Achieving Seroconversion at Day 21 Post-Vaccination With Influenza Vaccine.
    • Pre- and Post- Vaccination Geometric Mean Ratio (GMR)

Secondary outcomes

  1. Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80

    Time frame: Day 0 and Day 21 post-vaccination

  2. Immunogenicity compared to control group

    Time frame: Day 21 post vaccination, 6 months post vaccination

  3. Long-term Immunogenicity

    Time frame: 6 months post-vaccination

  4. Percentage of participants with Solicited Local Adverse Event (AE)

    Time frame: During 7 days post-vaccination

  5. Percentage of participants with Solicited Systemic Adverse Event (AE)

    Time frame: During 7 days post-vaccination

  6. Percentage of participants with Unsolicited Adverse Event (AE)

    Time frame: During 21 days post-vaccination

  7. Percentage of participants with Severe Adverse Event (SAE)

    Time frame: During 6 months post-vaccination

  8. Vital Sign

    Time frame: Day 0 and Day 21 post vaccination

    Body Temperature, Blood Pressure(SBP/DBP), Pulse

  9. Physical Examination

    Time frame: Day 0 and Day 21 post vaccination

    inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen)

  10. Clinical Laboratory Tests

    Time frame: Day 0 and Day 21 post vaccination

    Blood test(CBC, Coagulation, Chemistry), Urinalysis

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of NBP607 (Trivalent Inactivated Cell Culture-derived Influenza Vaccine) in Healthy Adults and Elderly Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 22, 2015
Registry last updated
Jan 22, 2015

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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