NCT01147081

A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of Begrivac®, Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 When Administered to Adult and Elderly Subjects

Completed Phase 3 Last updated 4 January 2012

What this trial tests

Phase 3 trial testing BEGRIVAC in Seasonal Influenza in 142 participants. Completed in 1 July 2010.

Timeline

1 June 2010

Primary endpoint
1 July 2010

1 July 2010

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	142
Start date	1 June 2010
Primary completion	1 July 2010
Estimated completion	1 July 2010
Sites	3 locations across Germany

Drugs / interventions tested

• BEGRIVAC

Conditions studied

• Seasonal Influenza — all drugs for Seasonal Influenza →

Sponsor

Novartis Vaccines — full company profile →

Who can join

18 and older, any sex, with Seasonal Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 1 and on Day 22, and evaluation of safety of Begrivac
  Time frame: 22 days (-1/+5)

Sponsor's own description

Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and immunogenicity of a trivalent single dose seasonal influenza vaccine containing pandemic A(H1N1) antigen in younger and elderly subjects: a phase III open-label single-arm study.
   Loebermann M, Anders G, Brestrich G, Fritzsche C, et al · · 2011 · cited 11× · PMID 21167116 · DOI 10.1016/j.vaccine.2010.11.092