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

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01000207

Enrollment

123

Registered

2009-10-22

Start date

2009-10-31

Completion date

2009-12-31

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

Swine-Origin Influenza A H1N1 Virus

Keywords

Influenza A, H1N1 subtype, Children/adolescent, Vaccine, Adjuvant

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 children/adolescents based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.

Detailed description

This is a multi-center, randomized, single-blind, dose-ranging study. Subjects were randomized at a 1:1 ratio to receive either 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75\_halfMF59) or 7.5μg of cell-derived H1N1sw vaccine formulated with full MF59 (7.5\_fullMF59). Subjects were not informed of their allocated doses. Two vaccinations were administered IM three weeks apart. Subjects in both the vaccine groups were stratified into three age strata: 6 to 35 months, 3 to 8 years and 9 to 19 years. Blood samples were collected at day 1 (baseline), three weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e., day 1 to day 7 and day 22 to day 28). All adverse events (AE), serious adverse events (SAE), and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

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

6 Months to 19 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese aged 6 months to 19 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