Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080221033

Enrollment

100

Registered

2010-03-02

Start date

2010-03-02

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Prevention of Swine-Origin Influenza A H1N1

Interventions

investigational material(s) Generic name etc : Cell-derived A/H1N1 Influenza HA Vaccine INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Japanese aged over 60 years

Exclusion criteria

Exclusion criteria: -Any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease) -History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients -Administration of swine influenza (A/H1N1) vaccine prior to Day 1 or documented confirmed or suspected swine influenza disease -History of progressive or sever neurological disorders -Known or suspected impairment/alteration of immune function

Design outcomes

Primary

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

Secondary

Measure	Time frame
Solicited reactions, AEs, vital signs, laboratory tests	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026