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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Due to limited data available on the safety and immune response to live attenuated influenza
      vaccine (LAIV) in breast-feeding women and the lack of information on the induction of
      immunoglobulin (Ig) A and IgG against influenza virus in breast milk, this study compares the
      safety in mothers and their infants and immunogenicity in mothers of standard dose
      inactivated trivalent influenza vaccine (TIV) and LAIV when administered between 28-120 days
      of delivery in breastfeeding women. This is a multi-site, randomized, double-blinded trial in
      240 post-partum breastfeeding women, 18-49 years of age and their infants. Once enrolled, a
      blood sample and a breast milk sample will be collected. Nasal swabs will be obtained and
      targeted physical examinations (TPE) will be conducted from mother and infant, if indicated.
      Each subject will receive either a single intramuscular (IM) 0.5 milliliter (mL) dose of TIV
      and 0.2 mL of placebo administered intranasally, or 0.2 mL intranasal dose of LAIV and 0.5 mL
      of placebo administered IM. All subjects will maintain a memory aid recording oral
      temperature, and systemic and local adverse events (AEs) for 8 days after study products have
      been administered. Approximately day 2 and 8 all subjects will return to the clinic for
      collection of breast milk samples and nasal swabs (mother and infant) and the memory aid will
      be reviewed. Approximately Day 28 after vaccination, all subjects will return to the clinic
      for breast milk and a blood sampling. During the time between vaccination and the day 28
      visit, if mother or infant has an influenza-like illness (ILI), a clinic visit may be
      required within 72 hours of illness onset. The clinic visit will be required for any illness
      that meets the Centers for Disease Control and Prevention's definition of an ILI for the
      mother. Investigator discretion will discern if an illness in the infant requires an ILI
      visit. Any respiratory or gastrointestinal (GI) serious adverse event (SAE) in the infant
      will also require a clinic visit. If the mother has an ILI, nasal swabs will be collected on
      her, and samples from the infant (if possible). If the infant has an ILI, nasal swabs will be
      collected on both the mother and infant. At approximately Day 42 after vaccination, all
      subjects will have a phone call for assessment of any medically attended GI or respiratory
      illness in the infant from Day 29-42. Approximately 6 months after vaccination all subjects
      will have a phone call for assessment of any SAEs in the subject or the infant since Day 42.
      SAE data and new onset chronic medical conditions in the mother will be collected from Day
      0-180. At all study visits, subjects will be asked about acute, temporary breast diseases
      (mastitis, abscesses) and any changes in breastfeeding, i.e., interruption and if so, how
      long (in weeks). Subjects will report information on current breast milk consumption by
      infant. Unsolicited non-serious AE data will be captured Day 0-28. Respiratory and GI AEs
      will be captured for the infant from Day 28-42. SAE data will be captured from Day 0-180 for
      both mother and infant. Blood samples will be tested for hemagglutination inhibition (HAI),
      IgG, and IgA as measured by enzyme linked-immunosorbent assay (ELISA). Breast milk samples
      will be assayed for IgA and IgG antibodies by ELISA. Breast milk and nasal swabs will also be
      tested for LAIV. Parent protocol to sub-study 11-0048.
    

Intervention name(s): Placebo; Cold-adapted live attenuated influenza virus vaccine, trivalent; Placebo; Trivalent inactivated influenza vaccine
Intervention type(s): Other; Biological; Other; Biological
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza, vaccine, breastfeeding, post-partum women, infant, LAIV, TIV, parent protocol