Clinical trial · Interventional
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
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.
NCT01022905CI-TRIAL-00003211completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| HIV Infection | — | UNRESOLVED | — |
| Pediatrics | — | UNRESOLVED | — |
| Rheumatic Disease | — | UNRESOLVED | — |
| Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvanted influenza A(H1N1) vaccines | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-risk patients ( 5 cohorts)
- interventionNames
- Biological: Adjuvanted influenza A(H1N1) vaccines
- type
- ACTIVE_COMPARATOR
- label
- Healthy controls
- interventionNames
- Biological: Adjuvanted influenza A(H1N1) vaccines
Primary outcomes (1)
- measure
- Antibody responses (inhibition of hemagglutination)
- timeFrame
- 4-6 weeks after immunization
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
Show eligibility criteria text
Inclusion Criteria: * medically recommended influenza A(H1N1) immunization * signed informed consent Exclusion Criteria: * failure or refusal to provide sufficient blood for antibody determination
References
Publications (5)
- DERIVEDSiegrist CA, van Delden C, Bel M, Combescure C, Delhumeau C, Cavassini M, Clerc O, Meier S, Hadaya K, Soccal PM, Yerly S, Kaiser L, Hirschel B, Calmy A; H1N1 Study Group; Swiss HIV Cohort Study (SHCS). Higher memory responses in HIV-infected and kidney transplanted patients than in healthy subjects following priming with the pandemic vaccine. PLoS One. 2012;7(7):e40428. doi: 10.1371/journal.pone.0040428. Epub 2012 Jul 27. PMID 22848378
- DERIVEDSchappi MG, Meier S, Bel M, Siegrist CA, Posfay-Barbe KM; H1N1 Study Group. Protective antibody responses to influenza A/H1N1/09 vaccination in children with celiac disease. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):817-9. doi: 10.1097/MPG.0b013e318248e7be. PMID 22228003
- DERIVEDMohty B, Bel M, Vukicevic M, Nagy M, Levrat E, Meier S, Grillet S, Combescure C, Kaiser L, Chalandon Y, Passweg J, Siegrist CA, Roosnek E; Blood and Marrow Transplant Program; Geneva University Hospitals H1N1 study group. Graft-versus-host disease is the major determinant of humoral responses to the AS03-adjuvanted influenza A/09/H1N1 vaccine in allogeneic hematopoietic stem cell transplant recipients. Haematologica. 2011 Jun;96(6):896-904. doi: 10.3324/haematol.2011.040386. Epub 2011 Mar 21. PMID 21422117
- DERIVEDMeier S, Bel M, L'huillier A, Crisinel PA, Combescure C, Kaiser L, Grillet S, Posfay-Barbe K, Siegrist CA; H1N1 Epidemiology Study Group of Geneva. Antibody responses to natural influenza A/H1N1/09 disease or following immunization with adjuvanted vaccines, in immunocompetent and immunocompromised children. Vaccine. 2011 Apr 27;29(19):3548-57. doi: 10.1016/j.vaccine.2011.02.094. Epub 2011 Mar 17. PMID 21419775
- DERIVEDGabay C, Bel M, Combescure C, Ribi C, Meier S, Posfay-Barbe K, Grillet S, Seebach JD, Kaiser L, Wunderli W, Guerne PA, Siegrist CA; H1N1 Study Group. Impact of synthetic and biologic disease-modifying antirheumatic drugs on antibody responses to the AS03-adjuvanted pandemic influenza vaccine: a prospective, open-label, parallel-cohort, single-center study. Arthritis Rheum. 2011 Jun;63(6):1486-96. doi: 10.1002/art.30325.