The Safety and Immune Response to Influenza Vaccination in Pregnant Women

NCT ID: NCT01514708

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

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.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

AdimFlu-S Influenza Vaccine

Intervention Type: BIOLOGICAL

Suspension for injection

Interventions

AdimFlu-S Influenza Vaccine

Suspension for injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Adimmune Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 23762229 (View on PubMed)

Other Identifiers

FLU11T12P

Identifier Type: -

Identifier Source: org_study_id