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Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.
At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | tacrolimus ointment 0.03% |
|
| 2 | Active Comparator | hydrocortisone acetate 1% and butyrate 0.1% |
|
| 3 | Other | Control group vaccination and challenge dose only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus ointment 0.03% | Drug | topical application |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with serum bactericidal antibody titer of ≥ 8 | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of other immunological parameters | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kogarah | New South Wales | 2217 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16798785 | Background | Hofman T, Cranswick N, Kuna P, Boznanski A, Latos T, Gold M, Murrell DF, Gebauer K, Behre U, Machura E, Olafsson J, Szalai Z; International Tacrolimus Ointment Study Group. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child. 2006 Nov;91(11):905-10. doi: 10.1136/adc.2006.094276. Epub 2006 Jun 23. |
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| hydrocortisone acetate ointment 1% | Drug | topical application |
|
|
| hydrocortisone butyrate ointment 0.1% | Drug | topical application |
|
|
| Meningitec | Biological | im injection |
|
| AC VAX | Biological | im injection |
|
| St Leonards |
| New South Wales |
| 2065 |
| Australia |
| Benowa | Queensland | 4217 | Australia |
| Carina Heights | Queensland | 4152 | Australia |
| Herston | Queensland | 4029 | Australia |
| North Adelaide | South Australia | 5006 | Australia |
| Carlton | Victoria | 3053 | Australia |
| Parkville | Victoria | 3052 | Australia |
| Fremantle | Western Australia | 6160 | Australia |
| Leuven | 3000 | Belgium |
| Bretten | 75015 | Germany |
| Ettenheim | 77955 | Germany |
| Gersfeld | 36129 | Germany |
| Kehl | 77694 | Germany |
| Tettnang | 88069 | Germany |
| Budapest | 1089 | Hungary |
| Debrecen | 4032 | Hungary |
| Pécs | 7624 | Hungary |
| Szeged | 6720 | Hungary |
| Kopavogur | 201 | Iceland |
| Saint Julians | Malta |
| Karpacz | 58-540 | Poland |
| Krakow | 30-633 | Poland |
| Lodz | 90-153 | Poland |
| Lodz | 91-347 | Poland |
| Opole | 45-372 | Poland |
| Poznan | 60-214 | Poland |
| Rabka-Zdrój | 34-700 | Poland |
| Warsaw | 01-219 | Poland |
| Warsaw | 04-740 | Poland |
| Wroclaw | 50-376 | Poland |
| Wroclaw | 51-136 | Poland |
| Zabrze | 41-800 | Poland |
| Zgierz | 95-100 | Poland |
| Lisbon | 1649-035 | Portugal |
| Porto | 4430 | Portugal |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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