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

Phase 2

Completed

• Conditions: Swine-Origin Influenza A H1N1 Virus
• Interventions: Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine

• Registration Number: NCT01000207
• Lead Sponsor: Novartis Vaccines

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine	Dose ranging
2	Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine	Dose ranging

Primary Outcome Measures

Name	Time	Method
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6	6 weeks

Secondary Outcome Measures

Name	Time	Method
AEs, vital signs, laboratory tests	6 weeks

Trial Locations

Locations (1)

Sites 1,2,3,4,5; 🇯🇵 Kagoshima, Japan