Status:
COMPLETED
Influenza Vaccine in Pregnant Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
FEMALE
18-39 years
Phase:
PHASE2
Brief Summary
In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to...
Detailed Description
Influenza is a significant cause of morbidity and mortality in the United States (US), resulting in an average of 226,000 hospitalizations and 36,000 deaths each year. Pregnant women and infants are a...
Eligibility Criteria
Inclusion
- Pregnant female between the ages of 18 and 39 years, inclusive.
- Is from 14 weeks of gestation to term, inclusive.
- Is in good health, as determined by vital signs (heart rate \<100 bpm; blood pressure: systolic \<140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature \<100.0 degrees Fahrenheit), medical history to ensure stable medical condition and a targeted physical examination based on medical history (if indicated). A stable medical condition is defined as health outcomes of the specific disease are considered to be within acceptable limits in the last 3 months.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedures.
- Agrees to sign medical release for herself and her infant(s) to allow study staff to gather pregnancy outcome data, if needed per clinical site policy.
Exclusion
- Receipt of the 2008-2009 seasonal influenza vaccine \[trivalent inactivated vaccine (TIV) or Flumist\] prior to enrollment into the study.
- Has a known allergy to eggs, egg proteins, latex allergy or allergy to other components in the vaccines (i.e. formaldehyde, polyethylene glycol p-isooctylphenyl ether, sucrose, gelatin, polysorbate 80).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study or expects to receive a licensed product prior to Visit 4 (Day 28 visit) (except for inactivated influenza vaccine which may be received 2 weeks post vaccination with study product). Measles, mumps, rubella vaccine is permitted post-partum.
- Has a moderate-to-severe acute illness and/or an oral temperature greater than or equal to 100.0 degrees Fahrenheit, within 72 hours prior to vaccination. (This may result in a temporary delay of vaccination).
- Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
- Has an active neoplastic disease, a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
- Long term use of oral or parenteral steroids, high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed) or has received steroids for treatment of pre-term labor during this pregnancy.
- Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to vaccination in this study.
- Has a diagnosis of a current and uncontrolled major psychiatric disorder.
- The subject is receiving listed psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving an antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
- Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- History of alcohol or drug abuse in the 1 year prior to enrollment.
- Has a history of Guillain-Barré syndrome.
- Has a seizure disorder or is on an anti-seizure medication for a seizure disorder.
- Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) during this pregnancy prior to enrollment, or expects to receive an experimental/investigational agent prior to Visit 4 (Day 28 visit).
- Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, transplant recipients, uncontrolled diabetes, juvenile diabetes (Type 1) or advanced diabetes with renal and eye disease; diabetes controlled by diet or oral agents is acceptable).
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00905125
Start Date
June 1 2009
End Date
March 1 2010
Last Update
June 13 2012
Active Locations (9)
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1
Emory University School of Medicine - Gynecology and Obstetrics
Atlanta, Georgia, United States, 30322
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
4
Mayo Clinic, Rochester - Vaccine Research Group
Rochester, Minnesota, United States, 55905