A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers

Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01450579

Enrollment

180

Registered

2011-10-12

Start date

2011-07-31

Completion date

2011-12-31

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Recombinant Influenza HA vaccine, Immunogenicity of ASP7373

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.

Interventions

BIOLOGICALASP7373

Intermuscular administration

BIOLOGICALPlacebo

Intramuscular administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs	up to 43 days	—
Immunogenicity (HI antibody titer)- first vaccine	on Day 21	—
Immunogenicity (HI antibody titer)- second vaccine	on Day 43	second vaccination on Day 22

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026