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
Not provided
Not provided
Not provided
Not provided
The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Quadrivalent influenza vaccine(containing 2 subtypes of B lineage) |
|
| Trivalent influenza vaccine A | Active Comparator | Trivalent influenza vaccine (containing B/Victoria lineage) |
|
| Trivalent influenza vaccine B | Active Comparator | Trivalent influenza vaccine (containing B/Yamagata lineage) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent influenza vaccine | Biological | 0.5 mL, intramuscular, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that presented seroconversion post injection |
| 30 days after inoculation |
| Geometric mean of Hemagglutination-inhibition titre post first study injection |
| 30 days after inoculation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that presented seroprotection post injection |
| 30 days after inoculation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hu Yuemei, PhD | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suining County Center for Disease Control and Prevention | Xuzhou | Jiangsu | China | |||
| Xinyi County Center for Disease Control and Prevention |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2018 | Nov 14, 2018 | Prot_SAP_000.pdf |
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
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Trivalent influenza vaccine A | Biological | 0.5 mL, intramuscular, one dose |
|
| Trivalent influenza vaccine B | Biological | 0.5 mL, intramuscular, one dose |
|
| Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs) |
|
| Continuous observation for 30 days after two inoculations |
| Xuzhou |
| Jiangsu |
| China |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |