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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 Pediatric 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 Pediatric Subjects

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221032
Enrollment
120
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

swine-origin Influenza A H1N1 Virus

Interventions

investigational material(s) Generic name etc : Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine INN of investigational material : Therapeutic

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy Japanese aged 6 months to 19 years

Exclusion criteria

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

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

Secondary

MeasureTime frame
AEs, vital signs, laboratory tests—

Outcome results

None listed

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