Influenza Vaccine in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone®; Fluarix®
Intervention description: Single 0.5 mL injection of the 2008-2009 seasonal inactivated trivalent influenza vaccine administered intramuscularly in the deltoid. Fluzone® does not contain thimerosal.; Single 0.5 mL injection of the 2008-2009 seasonal inactivated trivalent influenza vaccine administered intramuscularly in the deltoid. Fluarix® contains less than 1 microgram (trace or a very small amount) thimerosal per shot.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza, trivalent, vaccine, pregnant women

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 be pregnant or deliver during the flu season but only a few studies have
      measured a pregnant woman's immune response (the body's defense against the flu) after
      getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second
      or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this
      US based study. Participation will be about 8 months in duration. Women will be randomized
      (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on
      Day 0 and 28 days post vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.