Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Placebo; Cold-adapted live attenuated influenza virus vaccine, trivalent; Placebo; Trivalent inactivated influenza vaccine
Intervention description: 0.2 ml of Intranasal placebo study product (using sucrose phosphate placebo filled sprayers), will be administered to maternal subjects.; Licensed product formulated for the 2011-2012 or 2012-2013 influenza season. Standard dose LAIV (Flumist®) 0.1 ml administered to maternal subjects intranasally in each nostril for a total of 0.2 mL.; 0.5 ml of Sterile saline (0.9 percent Sodium Chloride for injection), administered IM to maternal subjects.; Preservative free, licensed product formulated for the 2011-2012 or 2012-2013 influenza season. Standard dose of TIV (Fluzone®) 0.5 ml administered to maternal subjects, IM in the deltoid.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza, vaccine, breastfeeding, post-partum women, infant, LAIV, TIV, parent protocol

Summary:

      The purpose of this research study is to learn more about the safety of 2 licensed flu
      vaccines, nasal spray and flu vaccine shot, in mothers and their infants, when given to women
      who are breastfeeding and to compare the immune response (body's defense against foreign
      substances) of breastfeeding mothers, who receive intranasal flu vaccine, with breastfeeding
      mothers receiving the flu vaccine shot. Healthy women (240 volunteers, 28-120 days post
      delivery) who plan to breastfeed through 28 days post vaccination and who have not received
      influenza vaccine for the influenza season for which they are being enrolled, will be
      assigned by chance to 1 of the 2 vaccines in the following manner: flu vaccine nasal spray
      and a placebo (inactive substance) shot or a flu vaccine shot and a placebo nasal spray.
      Study procedures include: nasal swabs, blood samples, and completion of memory aids.
      Participants will be involved in this United States based study for about 6 months.
    

Eligibility criteria:

        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.