Condition category
Infections and Infestations
Date applied
12/05/2010
Date assigned
21/01/2011
Last edited
21/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Seiberling

ORCID ID

Contact details

Covance Clinical Research Unit AG
Lettenweg 118
Allschwil
4123
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

INF-V-A004

Study information

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

Acronym

Study hypothesis

The Northern Hemisphere 2010/2011-season influenza vaccine fulfills the European Medicines Agency (EMEA) requirements for re-registration of influenza vaccines.

Ethics approval

Local Medical Ethics Committee (Ethikkommission beider Basel [EKBB]), Switzerland, approved on the 21 April 2010

Study design

Open non-randomised uncontrolled safety/efficacy study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2010

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Pregnancy and lactation
2. Serious adverse reaction to any influenza vaccine

Recruitment start date

01/06/2010

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Covance Clinical Research Unit AG
Allschwil
4123
Switzerland

Sponsor information

Organisation

Crucell Switzerland AG (Switzerland)

Sponsor details

Rehhagstrasse 79
Bern
3018
Switzerland
info@crucell.com

Sponsor type

Industry

Website

http://www.crucell.com

Funders

Funder type

Industry

Funder name

Crucell Switzerland AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes