2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women

Inclusion Criteria

Pregnant women:

• Pregnant female between the ages of 18 and 39 years, inclusive.
• Is a singleton pregnancy and is from 14 weeks/0 days through 33 weeks/6 days of gestation.
• Had at least one prenatal visit during which pregnancy was confirmed.
• Is in good health, as determined by vital signs [heart rate /= 100.0 degrees F, within 72 hours of vaccination (This may result in a temporary delay of vaccination).
• Has 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 (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants (a daily aspirin may be acceptable).
• Long term use of glucocorticoids, including oral or parenteral, or 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 betamethasone or dexamethasone to accelerate fetal lung maturity.
• Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.
• Has a diagnosis of a current and uncontrolled major psychiatric disorder.
• Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• The subject is receiving any of the following 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 (not listed above) and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• History of alcohol or drug abuse in the last 5 years.
• Has a seizure disorder or is on an anti-seizure medication.
• Has a history of Guillain-Barré Syndrome.
• Has an acute or chronic medical condition that, in the opinion of the investigator would render vaccination unsafe, or would interfere with the evaluation of responses (this includes, but is not limited to, known cardiac disease, chronic hypertension, chronic liver disease, significant renal disease, unstable or progressive neurological disorder, transplant recipients or diabetes, juvenile diabetes [Type I] or advanced diabetes with renal disease or eye disease. Gestational diabetes controlled by diet or insulin is acceptable).
• Has any of the following active medical conditions at the time of enrollment:

Hyperemesis gravidarium, premature labor (regular uterine contractions with cervical change), fetus with known major congenital anomaly or genetic abnormality, fetal growth restriction, preeclampsia, or known uterine anomaly (e.g. bicornuate uterus, submucosal fibroids > 5cm).

• Has a history of preeclampsia or preterm birth 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
• Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• Has a diagnosis of a current and uncontrolled major psychiatric disorder.
• Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• The subject is receiving any of the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluop