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

Influenza, Human Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344134
• Other study ID #: NBP607_FluA_III_2013
• 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

• Influenza, Human

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