Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine | Experimental | 120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart |
|
| Group 2 : 15 μg pandemic influenza A/H1N1 vaccine | Experimental | 120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart |
|
| Group 3 : 7.5 μg seasonal trivalent vaccine | Sham Comparator | 60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandemic influenza A/H1N1 vaccine | Biological | Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GuangXi Center for Diseases Control and Prevention | Guilin | Guangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23134570 | Derived | Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pandemic influenza A/H1N1 vaccine | Biological | Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose |
|
| Seasonal trivalent vaccine | Biological | Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |