NCT01069367

Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

Open-label, Uncontrolled Postmarketing Study to Evaluate Immunogenicity, Safety and Tolerability of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Elderly Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 61 Years
• Healthy volunteers: Accepted

Summary

This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety \& tolerability of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.

Detailed description

This is an open-label, uncontrolled post-marketing study of the cell-derived A/H1N1 influenza HA vaccine. Subjects received 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). All vaccination were administered IM in the deltoid muscle, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. Blood samples were collected at baseline (day1), 3 weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) assay. 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 AEs, SAEs, and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

Conditions

• Swine-Origin Influenza A H1N1 Virus

Interventions

Type	Name	Description
BIOLOGICAL	Emulsion, Cell Culture-based, influenza HA vaccine H1N1	Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-02-17
• Last updated: 2016-12-01

Locations

1 site across 1 country: Japan