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Completed

NCT Number: NCT01022905

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

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Cancer Communicable Diseases Connective Tissue Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Musculoskeletal Diseases Neoplasms Pediatrics RNA Virus Infections Retroviridae Infections Rheumatic Disease Rheumatic Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin and Connective Tissue Diseases Transplant Urogenital Diseases Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Geneva

Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • medically recommended influenza A(H1N1) immunization
  • signed informed consent

Exclusion criteria

  • failure or refusal to provide sufficient blood for antibody determination

Treatment and study plan

Adjuvanted influenza A(H1N1) vaccines

Biological

Immunization (1-2 doses)

Other names: Pandemrix (GSK), Focetria (Novartis)

Primary outcomes

  1. Antibody responses (inhibition of hemagglutination)

    Time frame: 4-6 weeks after immunization

Secondary outcomes

  1. Antibody responses (neutralization)

    Time frame: 4-6 weeks after immunization

  2. Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)

    Time frame: 4-6 weeks after immunization

  3. T cell responses

    Time frame: 4-6 wks after immunization

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2009
Registry last updated
Mar 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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