The Safety and Immune Response to Influenza Vaccination in Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: AdimFlu-S Influenza Vaccine

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose	Biological: AdimFlu-S Influenza Vaccine; Suspension for injection

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Adimmune Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Pregnancy; Influenza; Vaccine; Vaccination
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: FLU11T12P