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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
History of Changes
  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:

MedlinePlus related topics: Flu
U.S. FDA Resources

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
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

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 May 22, 2013