Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations

ISRCTN	ISRCTN89337058
DOI	https://doi.org/10.1186/ISRCTN89337058
Secondary identifying numbers	INF-V-A004

Submission date: 12/05/2010
Registration date: 21/01/2011
Last edited: 08/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Seiberling
Scientific

Covance Clinical Research Unit AG
Lettenweg 118
Allschwil
4123
Switzerland

Study information

Study design	Open non-randomised uncontrolled safety/efficacy study
Primary study design	Interventional
Secondary study design	Cohort study
Study setting(s)	Pharmaceutical testing facility
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations: an open label, non-randomised uncontrolled safety and efficacy study
Study objectives	The Northern Hemisphere 2010/2011-season influenza vaccine fulfills the European Medicines Agency (EMEA) requirements for re-registration of influenza vaccines.
Ethics approval(s)	Local Medical Ethics Committee (Ethikkommission beider Basel [EKBB]), Switzerland, approved on the 21 April 2010
Health condition(s) or problem(s) studied	Influenza
Intervention	Biological: single dose of trivalent virosomal adjuvanted influenza vaccine (Inflexal® V). Total duration of follow-up: approximately three weeks.
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected before, one, two and approximately three weeks after vaccination.
Secondary outcome measures	Safety, assessed at baseline and at three weeks after vaccination, including a four-day adverse event questionnaire, soliciting a set of local and systemic adverse events (AEs) according to the European Medicines Agency (EMEA) specifications.
Overall study start date	01/06/2010
Completion date	31/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	110
Key inclusion criteria	1. Healthy female and male volunteers equal to or older than 18 years of age on the day of enrolment 2. Written informed consent
Key exclusion criteria	1. Pregnancy and lactation 2. Serious adverse reaction to any influenza vaccine
Date of first enrolment	01/06/2010
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

Switzerland

Study participating centre

Covance Clinical Research Unit AG

Allschwil
4123
Switzerland

Sponsor information

Crucell Switzerland AG (Switzerland)
Industry

Rehhagstrasse 79
Bern
3018
Switzerland

Email	info@crucell.com
Website	http://www.crucell.com

Funders

Funder type

Industry

Crucell Switzerland AG (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Editorial Notes

08/02/2023: The study setting has been changed from ‘Other’.