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

This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine, breastfeeding, post-partum women, infant, LAIV, TIV, parent protocol Read More

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 beats per minute (bpm); blood pressure: systolic <150 mm Hg; diastolic <90 mm Hg; oral temperature <100.0 degrees Fahrenheit), medical history and a targeted physical examination if indicated based on medical history.
• Willing and capable of providing written informed consent for herself and infant.
• Available for entire study duration, clinic visits and phone calls.
• Planning on breast feeding from time of vaccination through 28 days post-vaccination. Breast milk must be at least one half of the source of the infant's feeding.
• Willing to practice adequate contraception for at least 28 days after receipt of study vaccine if not surgically sterile via post-partum tubal ligation, bilateral oophorectomy or hysterectomy. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with a vasectomized partner, barrier methods such as condoms or diaphragms with spermicides, or licensed hormonal methods that are compatible with breastfeeding an infant.
• May be reached by any IRB-approved form of communication during study period. May include telephone, email, web based, social media, and/or text messaging, based on specific local IRB recommendations.
• Agree to sign a medical release for herself and her infant (if needed) so that study personnel may obtain medical information about her or her infant's health.

Infant The infant(s) should be in good health as assessed by medical history, interview, rectal temperature and a targeted physical examination based on medical history.

• Infant born greater than or equal to 36 weeks gestation.
• Successful receipt of breast milk for at least two days prior to enrollment. Breast milk must be at least one half of the source of feeding, i.e., some supplementation is acceptable.

Exclusion Criteria:

Maternal Subject

• History of receipt of licensed influenza vaccine for the current influenza season. (If enrolled in 2011-2012 season [October 2011 - February 2012], subject must not have received 2011-2012 influenza vaccine. If enrolled in the 2012-2013 season [July 2012 or later], subject must not have received 2012-2013 influenza vaccine).
• History of previous participation in this study.
• Known allergy to eggs, egg proteins or other components in the vaccines (i.e. formaldehyde, polyethylene glycol, p-isooctylphenyl ether, sucrose, gelatin, polysorbate 80, gentamicin, arginine, sodium phosphate, sodium chloride, octylphenol ethoxylate, EDTA).
• If enrolled in the 2011-2012 season, known or suspected latex allergy. For the 2012-2013 season, known or suspected latex allergy is not a reason for exclusion.
• History of severe reactions following immunization with contemporary influenza virus vaccines.
• Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study, or expects to receive a licensed vaccine during the 28 days after vaccination in this study.
• Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to vaccination in this study, or expects to receive an experimental/investigational agent within the study time period (180 days after vaccination in this study).
• Received antiviral agent against influenza A and/or B within 48 hours prior to vaccination in this study. Antiviral agents should not be administered until 2 weeks after vaccination in this study unless medically necessary.
• A moderate to severe acute illness and/or an oral temperature >/= 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 disease or use of immunosuppressive therapy including perinatal exposure to or infection with HIV, or known infection with hepatitis B or hepatitis C.
• Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to this study, or expects to receive an experimental/investigational agent within the study time period (180 days after mother's vaccination in this study).
• A moderate to severe acute illness and/or a rectal temperature greater than or equal to 100.0 F (37.8 C), within 72 hours prior to mother's vaccination (This may result in a temporary delay of vaccination in mother).
• Received any licensed vaccines within 7 days prior to mother's vaccination in this study, or expects to receive a licensed vaccine during the 10 days after mother's vaccination in this study (This may result in a temporary delay of vaccination in mother).
• History of documented laboratory-confirmed influenza infection.
• Receipt of blood or blood products.
• Have a condition that may place the infant at an unacceptable risk of injury or would make it difficult for the infant to meet the requirements of the study.