Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women

Inclusion Criteria

Maternal Subject

• Women age 18-49 years of age (inclusive) within 28-120 days of delivery.
• Is in good health, as determined by vital signs (heart rate /= 100.0 F, within 72 hr 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.
• Active neoplastic disease or a history of any hematologic malignancy (cancers of blood or bone marrow) or current bleeding or blood clotting disorder.
• Current diagnosis of asthma.
• History of asthma, wheezing, or bronchospasm in the last 5 years.
• Long term (at least 14 days of prednisone 2 mg/kg or equivalent other glucocorticoid) use of oral or parenteral steroids, high-dose inhaled steroids (>800 microgram/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (topical steroids are allowed).
• Use of intranasal steroids within 14 days prior to vaccination in this study or within 14 days after receipt of study vaccine.
• Use of intranasal products within 6 hours prior to vaccination in this study or expects to use intranasal products within 6 hours post study vaccination.
• History of receiving immunoglobulin or other blood product (with exception of RhoGAM) within the 3 months prior to vaccination in this study.
• Diagnosis of a current and uncontrolled major psychiatric disorder.
• Has been hospitalized within the past 10 years for psychiatric illness, suicide attempt, or confinement for danger to self or others.
• 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 a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• The subject is receiving medications contraindicated with breast feeding.
• Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• An active neurological (such as, but not limited to seizure disorder), auto-immune or vascular disease.
• Active breast infection or breast abscess. (Study vaccination will be delayed until this breast infection or breast abscess has been treated and is resolved.)
• History of frequent epistaxis (nose bleeds).
• History of alcohol or drug abuse in the 1 year prior to enrollment.
• History of Guillain-Barré syndrome.
• Any known immunocompromised family member/household contact (such as active cancer, lupus, inflammatory bowel disease, HIV infection, or receipt of an organ or bone marrow transplant).
• 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, lung or heart disease, chronic anemia, metabolic disorders such as diabetes (resolved gestational diabetes is acceptable), significant renal disease, transplant recipients).
• Pregnant or planning to become pregnant during the 28 days after receipt of study vaccine.
• 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.

Infant

• Major congenital malformations.
• Syndromes that affect breastfeeding.
• Progressive neurological disease or a history of any seizure.
• Chronic lung disease or oxygen requirement for heart disease.
• History of bronchopulmonary dysplasia, wheezing, reactive airway disease, hospitalization for respiratory illness, or use of bronchodilators.
• Any receipt of glucocorticoids.
• Immunodeficiency d