## Protocol Section
### Identification Module
**NCT ID:** NCT01450579

**Brief Title:** A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers

**Official Title:** Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults

#### Organization Study ID Info
**ID:** 7373-CL-0106
#### Organization
**Class:** INDUSTRY
**Full Name:** UMN Pharma Inc.
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-09-29

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Start Date
**Date:** 2011-07

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2011-10-12
**Type:** ESTIMATED
**Study First Submit Date:** 2011-09-22
**Study First Submit QC Date:** 2011-10-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** UMN Pharma Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Recombinant Influenza HA vaccine

- Immunogenicity of ASP7373

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 180

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Saline

**Intervention Names:**

- Biological: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** ASP7373

**Intervention Names:**

- Biological: ASP7373

**Label:** Dose -1

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** ASP7373

**Intervention Names:**

- Biological: ASP7373

**Label:** Dose -2

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** ASP7373

**Intervention Names:**

- Biological: ASP7373

**Label:** Dose -3

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dose -1

- Dose -2

- Dose -3

**Description:** Intermuscular administration

**Name:** ASP7373

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Intramuscular administration

**Name:** Placebo

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs

**Time Frame:** up to 43 days

**Measure:** Immunogenicity (HI antibody titer)- first vaccine

**Time Frame:** on Day 21

**Description:** second vaccination on Day 22

**Measure:** Immunogenicity (HI antibody titer)- second vaccine

**Time Frame:** on Day 43

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion Criteria:

* Scheduled to receive another vaccine during study period
* History of H5 influenza infection or received H5 influenza vaccine
* Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* 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 or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
* History of seizures
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kyushu

**Country:** Japan

#### Overall Officials

**Official 1:**

**Affiliation:** Astellas Pharma Inc

**Name:** Use Central Contact

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
