Condition category
Haematological Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
09/11/2007
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 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

http://www.rug.nl/umcg/index?lang=en

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

Publication citations

Additional files

Editorial Notes