Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients

Cancer Clinical Trial

Official title:

Prospective Cohort Study of the Influence of Age, Underlying Disease and Immunosuppression on Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022905
• Other study ID #: CER-09-234
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: February 26, 2010
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess vaccine responses to novel adjuvanted influenza A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.

Description:

This prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250 controls to whom influenza A(H1N1) immunization was recommended.

Six cohort have been established, enrolling patients with HIV infection, rheumatic diseases, organ transplant, cancer, pediatric patients and healthy controls.

Subjects will be assessed for specific antibody responses (all), T cell responses (subset) and solicited vaccine adverse events. Vaccine safety evaluation will include the influence of immunization on underlying diseases (HIV infected patients, patients with auto-immune diseases) or graft function (transplant patients) - as appropriate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1141
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• medically recommended influenza A(H1N1) immunization

• signed informed consent

Exclusion Criteria:

• failure or refusal to provide sufficient blood for antibody determination

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• HIV Infection
• HIV Infections
• Pediatrics
• Rheumatic Disease
• Rheumatic Diseases
• Transplant

Intervention

Biological:
• Adjuvanted influenza A(H1N1) vaccines
Immunization (1-2 doses)

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody responses (inhibition of hemagglutination)		4-6 weeks after immunization	No
Secondary	Antibody responses (neutralization)		4-6 weeks after immunization	No
Secondary	Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)		4-6 weeks after immunization	Yes
Secondary	T cell responses		4-6 wks after immunization	No