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

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

NBP607

Agrippal S1

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NBP607

Agrippal S1

Arm Description

cell culture-derived trivalent inactivated subunit influenza vaccine

egg-derived trivalent inactivated subunit influenza vaccine

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Immunogenicity compared to control group

Long-term Immunogenicity

Percentage of participants with Solicited Local Adverse Event (AE)

Percentage of participants with Solicited Systemic Adverse Event (AE)

Percentage of participants with Unsolicited Adverse Event (AE)

Percentage of participants with Severe Adverse Event (SAE)

Vital Sign

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

Physical Examination

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

Clinical Laboratory Tests

Blood test(CBC, Coagulation, Chemistry), Urinalysis

Full Information

NCT ID

NCT02344134

First Posted

December 24, 2014

Last Updated

January 16, 2015

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02344134

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1155 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NBP607

Arm Type

Experimental

Arm Description

cell culture-derived trivalent inactivated subunit influenza vaccine

Arm Title

Agrippal S1

Arm Type

Active Comparator

Arm Description

egg-derived trivalent inactivated subunit influenza vaccine

Intervention Type

Biological

Intervention Name(s)

NBP607

Intervention Description

0.5 mL, intramuscular, a single dose

Intervention Type

Biological

Intervention Name(s)

Agrippal S1

Intervention Description

0.5 mL, intramuscular, a single dose

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Day 0 and Day 21 post-vaccination

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 0 and Day 21 post-vaccination

Title

Immunogenicity compared to control group

Time Frame

Day 21 post vaccination, 6 months post vaccination

Title

Long-term Immunogenicity

Time Frame

6 months post-vaccination

Title

Percentage of participants with Solicited Local Adverse Event (AE)

Time Frame

During 7 days post-vaccination

Title

Percentage of participants with Solicited Systemic Adverse Event (AE)

Time Frame

During 7 days post-vaccination

Title

Percentage of participants with Unsolicited Adverse Event (AE)

Time Frame

During 21 days post-vaccination

Title

Percentage of participants with Severe Adverse Event (SAE)

Time Frame

During 6 months post-vaccination

Title

Vital Sign

Description

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

Time Frame

Day 0 and Day 21 post vaccination

Title

Physical Examination

Description

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

Time Frame

Day 0 and Day 21 post vaccination

Title

Clinical Laboratory Tests

Description

Blood test(CBC, Coagulation, Chemistry), Urinalysis

Time Frame

Day 0 and Day 21 post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: