CompletedPhase 2/3

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

Japan123 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range6 Months – 19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6

Timeframe: 6 weeks

Trial details

NCT IDNCT01000207

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Swine-Origin Influenza A H1N1 Virus trials