The Safety and Immune Response to Influenza Vaccination in Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01514708
First received: January 18, 2012
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: AdimFlu-S Influenza Vaccine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Safety and Immune Response to Influenza Vaccination in Pregnant Women

Resource links provided by NLM:


Further study details as provided by Adimmune Corporation:

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. [ 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: The safety information is collected from the day of vaccination to 8 weeks after the delivery. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 46
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose Biological: AdimFlu-S Influenza Vaccine
Suspension for injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514708

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Adimmune Corporation
  More Information

No publications provided by Adimmune Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01514708     History of Changes
Other Study ID Numbers: FLU11T12P
Study First Received: January 18, 2012
Last Updated: December 27, 2012
Health Authority: Taiwan: Taiwan Food and Drug Administration

Keywords provided by Adimmune Corporation:
Influenza
Vaccination
Vaccine
Pregnancy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014