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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02344134
Other study ID # NBP607_FluA_III_2013
Secondary ID
Status Completed
Phase Phase 3
First received December 24, 2014
Last updated January 16, 2015
Start date September 2013
Est. completion date May 2014

Study information

Verified date December 2014
Source SK Chemicals Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1155
Est. completion date May 2014
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
NBP607
0.5 mL, intramuscular, a single dose
Agrippal S1
0.5 mL, intramuscular, a single dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
SK Chemicals Co.,Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen 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)
Day 0 and Day 21 post-vaccination No
Secondary Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80 Day 0 and Day 21 post-vaccination No
Secondary Immunogenicity compared to control group Day 21 post vaccination, 6 months post vaccination No
Secondary Long-term Immunogenicity 6 months post-vaccination No
Secondary Percentage of participants with Solicited Local Adverse Event (AE) During 7 days post-vaccination Yes
Secondary Percentage of participants with Solicited Systemic Adverse Event (AE) During 7 days post-vaccination Yes
Secondary Percentage of participants with Unsolicited Adverse Event (AE) During 21 days post-vaccination Yes
Secondary Percentage of participants with Severe Adverse Event (SAE) During 6 months post-vaccination Yes
Secondary Vital Sign Body Temperature, Blood Pressure(SBP/DBP), Pulse Day 0 and Day 21 post vaccination Yes
Secondary Physical Examination inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen) Day 0 and Day 21 post vaccination Yes
Secondary Clinical Laboratory Tests Blood test(CBC, Coagulation, Chemistry), Urinalysis Day 0 and Day 21 post vaccination Yes
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