An open-label pilot study on the effects of trivalent inactivated influenza vaccination (Influvac®) in patients with hypo- and dysgammaglobulinemia

ISRCTN ISRCTN31814323
DOI https://doi.org/10.1186/ISRCTN31814323
Secondary identifying numbers N/A
Submission date
28/12/2006
Registration date
28/12/2006
Last edited
10/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S van Assen
Scientific

University Medical Center Groningen
Department of Internal Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands

s.van.assen@int.umcg.nl

Study information

Study designNon-randomised, controlled, parallel group, multicentre trial.
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Not specified
Study typePrevention
Scientific titleAn open-label pilot study on the effects of trivalent inactivated influenza vaccination (Influvac®) in patients with hypo- and dysgammaglobulinemia
Study acronymVIPID
Study objectivesPatients with hypo- or dysgammaglobulinemia have comparable cellular immune response to influenza vaccine as matched healthy volunteers.
Ethics approval(s)Approval received from the Medisch Ethische Toetsingcommissie van het Universitair Medisch Centrum Groningen on the 18th July 2006 (ref: METc2006.124).
Health condition(s) or problem(s) studiedHypo- or Dysgammaglobulinemia
InterventionVaccination with trivalent inactivated influenza vaccine (Influvac®)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Influvac®
Primary outcome measureCellular immune responses
Secondary outcome measures1. Humoral immune responses
2. Side effects
Overall study start date01/10/2006
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participants100
Total final enrolment30
Key inclusion criteria1. 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
Key exclusion criteria1. 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®
Date of first enrolment01/10/2006
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Department of Internal Medicine
P.O. Box 30001
Groningen
9700 RB
Netherlands

http://www.rug.nl/umcg/index?lang=en
ROR logo https://ror.org/03cv38k47

Funders

Funder type

Research organisation

De Cock Stichting (The Netherlands) -a society supporting research in the city of Groningen (http://www.decockstichting.nl/)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/11/2011 10/06/2021 Yes No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.

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