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

Novartis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Swine-Origin Influenza A H1N1 Virus

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01000207

V110_08

Details and patient eligibility

About

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.

Full 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.

Enrollment

123 patients

Sex

All

Ages

6 months to 19 years old

Volunteers

Accepts Healthy Volunteers

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