A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers

Study for Immunogenicity and Safety of ASP7374 for Subcutaneous and Intramuscular Vaccination in Healthy Adults

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393951

Enrollment

165

Registered

2011-07-14

Start date

2011-05-31

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, Immunogenicity of ASP7374

Keywords

Recombinant Influenza hemagglutinin vaccine

Brief summary

This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.

Interventions

BIOLOGICALASP7374

subcutaneous and intramuscular

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 49 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 participation period * Received influenza vaccine within 180 days prior to the study * 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 * Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome * 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) * Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Design outcomes

Primary

Measure	Time frame
Immunogenicity: HI antibody titer	Day 29
Safety: Incidence of Adverse events, vital signs and laboratory tests	28 days post-vaccination

Countries

Japan

Outcome results

None listed

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