Clinical trial NCT02917304: A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older
Official title: A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Quadrivalent Influenza Vaccines
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 274
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

Detailed description: Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 65 years and older
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria:

* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barre syndrome(GBS)
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Primary outcomes:
measure: Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
timeFrame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
measure: Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
timeFrame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary outcomes:
measure: Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
timeFrame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: The Catholic Univ. of Korea Daejeon St.Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ.of Korea Bucheon St.Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: EWHA woman's university mokdong hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Incheon St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ.of Korea Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Study officials:
References: