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The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdimFlu-S Influenza Vaccine | Biological | Suspension for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. | The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. Immunogenicity profile will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. | Immunogenicity profile was assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. Moreover, the HAI titer of the cord blood was also measured and compared with the maternal blood sample. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S. | Safety outcomes include immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events until the first post-vaccination serum collected (Day 28), and serious adverse events and adverse events of special interest until 8 weeks after the delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23762229 | Derived | Lin SY, Wu ET, Lin CH, Shyu MK, Lee CN. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan. PLoS One. 2013 Jun 6;8(6):e62983. doi: 10.1371/journal.pone.0062983. Print 2013. |
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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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| The safety information is collected from the day of vaccination to 8 weeks after the delivery. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |