Contact information
Type
Scientific
Primary contact
Dr S van Assen
ORCID ID
Contact details
University Medical Center Groningen
Department of Internal Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands
s.van.assen@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
VIPID
Study hypothesis
Patients with hypo- or dysgammaglobulinemia have comparable cellular immune response to influenza vaccine as matched healthy volunteers.
Ethics approval
Approval received from the Medisch Ethische Toetsingcommissie van het Universitair Medisch Centrum Groningen on the 18th July 2006 (ref: METc2006.124).
Study design
Non-randomised, controlled, parallel group, multicentre trial.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Hypo- or Dysgammaglobulinemia
Intervention
Vaccination with trivalent inactivated influenza vaccine (Influvac®)
Intervention type
Drug
Phase
Not Specified
Drug names
Influvac®
Primary outcome measures
Cellular immune responses
Secondary outcome measures
1. Humoral immune responses
2. Side effects
Overall trial start date
01/10/2006
Overall trial end date
30/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients have to fulfil the diagnostic criteria for primary immunodeficiency as defined by the Pan-American Group for Immunodeficiency and the European Society for immunodeficiencies
2. Informed consent
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Age under 18 years
2. Current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment
3. Pregnancy
4. Malignancy
5. Continuous use of immunosuppressive drugs
6. Known allergy to any substance of Influvac®
Recruitment start date
01/10/2006
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (The Netherlands)
Sponsor details
Department of Internal Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
De Cock Stichting (The Netherlands) -a society supporting research in the city of Groningen (http://www.decockstichting.nl/)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The main cost of this trial will be covered by internal supplies.
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