Influenza Vaccine in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or
      hospitalization. In the United States (US) it is recommend that all women get flu vaccine if
      they are going to be pregnant or deliver during the flu season but only a few studies have
      measured a pregnant woman's immune response (the body's defense against the flu) after
      getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second
      or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this
      US based study. Participation will be about 8 months in duration. Women will be randomized
      (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on
      Day 0 and 28 days post vaccination.
    

Detailed description: 
      Influenza is a significant cause of morbidity and mortality in the United States (US),
      resulting in an average of 226,000 hospitalizations and 36,000 deaths each year. Pregnant
      women and infants are at an increased risk for the complications of influenza. Severe
      disease, emergency department visits and hospitalizations occur frequently in pregnant women
      and infants which are considered high risk populations. In the US, routine vaccination with
      inactivated trivalent influenza vaccine (TIV) is recommended for pregnant women or those who
      deliver during the influenza season. Few studies exist on the safety and immunogenicity of
      administration of seasonal inactivated TIV despite long-standing recommendations. Although
      influenza vaccination has been recommended during pregnancy, the rates of immunization remain
      low, at about 13 percent. This is a multi-site randomized, double-blind clinical trial in 200
      ambulatory, medically stable 18-39 year old, inclusive, pregnant women in their second or
      third trimester of pregnancy (from 14 weeks of gestation to term, inclusive). Study subjects
      will be randomized 1:1 to receive one dose of a 2008-2009 seasonal inactivated TIV, either
      Fluzone® or Fluarix® (100 pregnant women per vaccine group). Once enrolled, a blood sample
      will be collected and each subject will receive a single 0.5 mL dose of a 2008-2009 seasonal
      inactivated TIV, either Fluzone® or Fluarix®. The vaccination will occur on Day 0. Subjects
      will be observed for approximately 15 minutes after vaccination. All subjects will maintain a
      memory aid recording oral temperature, and systemic and local adverse events (AEs) for 7 days
      after each vaccination. Subjects will be encouraged to take their temperature around the same
      time each day. Subjects will have a phone call on Day 2 for review of memory aid, concomitant
      medication assessment, and assessment of AEs. Subjects will have a phone call on Day 8 for AE
      assessment, concomitant medication assessment and review of memory aid. At approximately Day
      28 after the vaccination, subjects will return to the clinic for immunogenicity blood sample
      collection, concomitant medication assessment, and assessment of any AEs. A targeted physical
      exam will be conducted, if indicated. At approximately Day 180 or 6 months after vaccination,
      subjects will have a phone call for assessment for any serious adverse events (SAEs).
      Unsolicited non-serious AE data will be captured Day 0 through Day 28. Maternal SAE data will
      be captured throughout the study period (Day 0 through Day 180, approximately 6 months after
      dose of vaccine). Maternal and infant SAE data will be collected when obtaining data on
      pregnancy outcome. Serum for immunogenicity evaluations will be obtained prior to the dose of
      vaccine (at Day 0); and one month after vaccination (at Day 28). Pregnancy outcome data will
      be captured by a review of medical records and a phone call to the subject. Data include any
      complications during labor and delivery for both the mother as well as the neonate, to
      include premature delivery or delivery by emergency cesarean section. Neonatal assessments
      will include but not be limited to gestational age, birth weight, Apgar scores, congenital
      abnormalities, infection, hematological and metabolic complications, admission to nursery or
      Neonatal Intensive Care Unit and the need for respiratory support. Blood samples collected
      will be tested in a central laboratory for the levels of hemagglutination inhibition (HAI)
      and microneutralization (MN) antibodies.
    

Intervention name(s): Fluzone®; Fluarix®
Intervention type(s): Biological; Biological
Intervention description(s): Single 0.5 mL injection of the 2008-2009 seasonal inactivated trivalent influenza vaccine administered intramuscularly in the deltoid. Fluzone® does not contain thimerosal.; Single 0.5 mL injection of the 2008-2009 seasonal inactivated trivalent influenza vaccine administered intramuscularly in the deltoid. Fluarix® contains less than 1 microgram (trace or a very small amount) thimerosal per shot.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza, trivalent, vaccine, pregnant women