Study of ASP7374, Cell-culture-derived Influenza Vaccine

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－

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961947
• Other study ID #: 7374-CL-0102
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2013
• Last updated: September 27, 2017
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2017
• Source: UMN Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Vaccine

Intervention

Biological:
• ASP7374
subcutaneous
• approved egg-derived TIV
subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMN Pharma Inc.

Country where clinical trial is conducted

Japan, 

Outcome

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