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The Safety and Immune Response to Influenza Vaccination in Pregnant Women

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
AdimFlu-S Influenza Vaccine
Sponsored by
Adimmune Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccination, Vaccine, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 18, 2012
Last Updated
July 12, 2018
Sponsor
Adimmune Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01514708
Brief Title
The Safety and Immune Response to Influenza Vaccination in Pregnant Women
Official Title
The Safety and Immune Response to Influenza Vaccination in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adimmune Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccination, Vaccine, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AdimFlu-S Influenza Vaccine
Intervention Description
Suspension for injection
Primary Outcome Measure Information:
Title
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.
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 will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period.
Time Frame
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 Measure Information:
Title
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.
Description
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.
Time Frame
The safety information is collected from the day of vaccination to 8 weeks after the delivery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23762229
Citation
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.
Results Reference
derived

Learn more about this trial

The Safety and Immune Response to Influenza Vaccination in Pregnant Women

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