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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23525

Enrollment

100

Registered

2006-09-08

Start date

2006-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with hypo- or dysgammaglobulinemia fullfilling the criteria for primary immunodeficiency as defined by the Pan-American Group for Immunodeficiency and the European Society for immunodeficiencies

Interventions

Vaccination with trivalent inactivated influenza vaccin (Influvac®).

Eligibility

Inclusion criteria

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.

Exclusion criteria

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®.

Design outcomes

Primary

Measure	Time frame
Cellular immune responses.	—

Secondary

Measure	Time frame
1. Humoral immune responses; 2. Side effects.	—

Contacts

Public ContactS. Assen, van

University Medical Center Groningen (UMCG), Department of Internal Medicine P.O. Box 30001

s.van.assen@int.umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)