Influenza
Conditions
Keywords
Influenza, Vaccination, Vaccine, Pregnancy
Brief summary
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.
Interventions
BIOLOGICALAdimFlu-S Influenza Vaccine
Suspension for injection
Sponsors
Adimmune Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant female aged ≥ 18 years old. 2. Subject is pregnant for at least 3 months, inclusive. 3. Subject is willing and able to adhere to visit schedules and all study requirements. 4. Subject has read and signed the study-specific informed consent.
Exclusion criteria
1. Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion; 2. Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia; 3. Subject received any influenza vaccine within the previous 6 months; 4. Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine; 5. Subject or her family has the history of Guillain-Barré Syndrome; 6. Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours; 7. Subject with influenza-like illness as defined by the presence of fever (temperature over 38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough; 8. Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; 9. Subject has immunodeficiency or is under immunosuppressive treatment. 10. Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination; 11. Subject received any blood products, including immunoglobulin, in the past 3 months before consent; 12. Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | The safety information is collected from the day of vaccination to 8 weeks after the delivery. | 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. |
Countries
Taiwan
Outcome results
None listed