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 |
| Protocol serial number | N/A |
| Sponsor | University Medical Center Groningen (UMCG) (The Netherlands) |
| Funder | De Cock Stichting (The Netherlands) -a society supporting research in the city of Groningen (http://www.decockstichting.nl/) |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, controlled, parallel group, multicentre trial. |
| Secondary study design | Non randomised study |
| Scientific title | An open-label pilot study on the effects of trivalent inactivated influenza vaccination (Influvac®) in patients with hypo- and dysgammaglobulinemia |
| Study acronym | VIPID |
| Study objectives | Patients 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) studied | Hypo- or Dysgammaglobulinemia |
| Intervention | Vaccination with trivalent inactivated influenza vaccine (Influvac®) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Influvac® |
| Primary outcome measure(s) |
Cellular immune responses |
| Key secondary outcome measure(s) |
1. Humoral immune responses |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Total final enrolment | 30 |
| Key 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 |
| Key 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® |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
