The Safety and Immune Response to Influenza Vaccination in Pregnant Women

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Immune Response to Influenza Vaccination in Pregnant Women

Conditions
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Influenza

Intervention / Treatment
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* Biological: AdimFlu-S Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant female aged ≥ 18 years old. Subject is pregnant for at least 3 months, inclusive. Subject is willing and able to adhere to visit schedules and all study requirements. Subject has read and signed the study-specific informed consent. Exclusion Criteria: Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion; Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia; Subject received any influenza vaccine within the previous 6 months; Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine; Subject or her family has the history of Guillain-Barré Syndrome; Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours; 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; Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; Subject has immunodeficiency or is under immunosuppressive treatment. Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination; Subject received any blood products, including immunoglobulin, in the past 3 months before consent; Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose<br> | Biological: AdimFlu-S Influenza Vaccine<br>* Suspension for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | The safety information is collected from the day of vaccination to 8 weeks after the delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccination, Vaccine, Pregnancy