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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number 2009-013131-38 |
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The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A (3.75 µg HA antigen, 0.25 mL) | Experimental | Within each age stratum (4 age strata) subjects will be randomized 1:1 to receive two vaccinations of either Dose A (3.75 µg) or Dose B (7.5 µg) of H1N1 pandemic influenza vaccine at a 21-day interval. |
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| Dose B (7.5µg HA antigen, 0.5 mL) | Experimental | Within each age stratum (4 age strata) subjects will be randomized 1:1 to receive two vaccinations of either Dose A (3.75 µg) or Dose B (7.5µg) of H1N1 pandemic influenza vaccine at a 21-day interval. A booster vaccination with a licensed seasonal trivalent influenza vaccine for the season 2010/2011 will be administered to at least 30 subjects in each age stratum (who have received Dose B) at 360 days after the first vaccination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated) | Biological | 2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the immune response to two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years | 42 days | |
| To assess the safety of two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years | Within 7 days after each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva-Maria Pöllabauer, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practice | Eferding | Upper Austria | 4070 | Austria | ||
| General Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22846396 | Derived | Loew-Baselli A, Pavlova BG, Fritsch S, Poellabauer EM, Draxler W, Kistner O, Behre U, Angermayr R, Neugebauer J, Kirsten K, Forster-Waldl E, Koellges R, Ehrlich HJ, Barrett PN. A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory. Vaccine. 2012 Sep 7;30(41):5956-66. doi: 10.1016/j.vaccine.2012.07.039. Epub 2012 Jul 28. |
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| Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011 | Biological | Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine) |
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| Wels |
| Upper Austria |
| 4600 |
| Austria |
| Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna) | Vienna | 1090 | Austria |
| General Practice | Ettenheim | 77955 | Germany |
| General Practice | Kehl | 77694 | Germany |
| General Practice | Mönchengladbach | 41236 | Germany |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008004 | Licensure |
| C475022 | Inflexal V |
| ID | Term |
|---|---|
| D003406 | Credentialing |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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