Trial | NCT02344134  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1155
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.
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.
Study Started
Sep 30
2013
Primary Completion
Nov 30
2013
Study Completion
May 31
2014
Last Update
Jan 22
2015
Estimate

Biological NBP607

0.5 mL, intramuscular, a single dose

Biological Agrippal S1

0.5 mL, intramuscular, a single dose

NBP607 Experimental

cell culture-derived trivalent inactivated subunit influenza vaccine

Agrippal S1 Active Comparator

egg-derived trivalent inactivated subunit influenza vaccine

Criteria 

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.
No Results Posted