Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996138

Enrollment

200

Registered

2009-10-16

Start date

2009-09-30

Completion date

2009-11-30

Last updated

2016-12-01

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

Conditions

Influenza

Keywords

Influenza A, H1N1 subtype, Adult, Vaccine, Adjuvant, Swine-Origin Influenza A H1N1 Virus

Brief summary

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

Interventions

BIOLOGICALAdjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine

High dose group and low dose group of adjuvanted vaccines

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

29 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese adults aged 20 to 60 years

Exclusion criteria

* History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients * Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start * Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week * History of progressive or severe neurological disorders

Design outcomes

Primary

Measure	Time frame
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6	6 weeks

Secondary

Measure	Time frame
AEs, vital signs, laboratory tests	6 weeks

Countries

Japan

Outcome results

None listed

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