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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Institute of Experimental Medicine, Russia | OTHER |
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This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H7N9 LAIV | Active Comparator | H7N9 live influenza vaccine |
|
| Placebo | Placebo Comparator | Lyophilized purified allantoic fluid of chicken embryos with stabilizers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H7N9 live influenza vaccine | Biological | H7N9 live influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate reactions | Immediate reactions occurring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff | 2 hours |
| Solicited adverse events | Adverse events commonly associated with intranasal vaccination (solicited local and systemic reactions), measured as observed by study staff or reported by the subject to study staff | Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose |
| Changes from baseline in laboratory findings | Abnormal laboratory findings from blood and urine specimens | Days 3, 6 and 34 |
| Serious adverse events (SAEs) | All SAEs during 56 days, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card, including abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56 | 4 weeks of receipt of any dose |
| Measure | Description | Time Frame |
|---|---|---|
| Immune responses | Immune responses was parameterized as the proportion of subjects with at least a four-fold rise after each dose from baseline or as the mean titer after each dose in any of the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immune responses (cytokine and T-cell) | Cellular immune responses (cytokine and T-cell) was measured using isolated peripheral blood mononuclear cells (PBMCs) tested by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) assay. | Days 0, 28 and 56 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larisa G Rudenko, MD PhD DSc | Institute of Experimental Medicine | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26673391 | Derived | Rudenko L, Isakova-Sivak I, Naykhin A, Kiseleva I, Stukova M, Erofeeva M, Korenkov D, Matyushenko V, Sparrow E, Kieny MP. H7N9 live attenuated influenza vaccine in healthy adults: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2016 Mar;16(3):303-10. doi: 10.1016/S1473-3099(15)00378-3. Epub 2015 Dec 8. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Biological | Lyophilized purified allantoic fluid of chicken embryos with stabilizers |
|
| Days 0, 28 and 56 |
| Virus shedding | Virus shedding with virus detected by real-time reverse transcriptase polymerase chain reaction rRTPCR in nasal swabs at any time point (at day of vaccination and daily during hospitalization). | Days 0-6 after each dose |
| Virus stability | Virus stability (virus detected and sequenced after inoculation into chicken eggs) | Days 0-6 after each dose |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |