Influenza Clinical Trial
Official title:
Phase 3 Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Adults ≥20 and <65 Years of Age-
Verified date | September 2017 |
Source | UMN Pharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and <65 years.
Status | Completed |
Enrollment | 900 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Healthy or medically stable, as judged on the basis of history and concurrent diseases. - Subject understands procedure of the protocol and is willing to comply with the protocol. - Written informed consent has been obtained. Exclusion Criteria: - Scheduled to receive another vaccine during the study. - Received influenza HA vaccine within 180 days prior to screening. - Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine. - Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome. - Received one of the following medications or treatment prior to vaccination with the study vaccine. - Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion - History of anaphylactic shock or an allergic reaction such as generalized eruption due to food (including chicken, poultry, foodstuffs derived from chicken, et al.) or drug (including vaccines) allergies, fever =39.0°C within 2 days after the previous vaccination (influenza vaccine and others) - History of seizures, except for febrile seizures in childhood |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
UMN Pharma Inc. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | seroconversion rate of hemagglutination inhibition (HI) antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | |
Primary | geometric mean titer (GMT) of HI antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | |
Secondary | seroprotection rate of HI antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | |
Secondary | GMT ratio of HI antibody titer (Day 29/Day 1) | evaluated for A/H1N1, A/H3N2, and B | Day1 and Day 29 | |
Secondary | seroconversion rate of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | |
Secondary | seroprotection of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | |
Secondary | GMT of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 | |
Secondary | GMT ratio of neutralizing antibody titer (Day 29/Day 1) | evaluated for A/H1N1, A/H3N2, and B | Day 1 and Day 29 | |
Secondary | Local and systemic reactions associated with the vaccination | Day 1 through Day 8 |
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