2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see how much antibody (proteins produced by the immune system
      that help fight infections) the body makes after getting a flu vaccine. Researchers will also
      look at how the body reacts to the flu vaccine and how it affects the babies of pregnant
      women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant
      women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60
      non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine
      groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine.
      The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper
      arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient
      participation may be up to 8 months. The information from this study will help guide
      researchers in developing flu vaccines for pregnant women.
    

Detailed description: 
      Influenza is a significant cause of morbidity and mortality in the United States. Pregnant
      women and infants are at an increased risk for the complications of influenza. Pregnant women
      are considered a high risk population. In the United States, routine vaccination with
      inactivated trivalent influenza vaccine (TIV) for women who are pregnant or deliver during
      the influenza season is recommended. However, few studies exist on the safety and
      immunogenicity of administration of seasonal inactivated TIV. Although influenza vaccination
      has been recommended during pregnancy, the rates of immunization remain low, at about 13
      percent, which partly reflects concern of safety among pregnant women and providers. It is
      important to gather prospective data on the safety and immunogenicity of inactivated TIV
      vaccine in pregnant women. This is a multi-site randomized, double-blinded clinical trial in
      180 healthy 18-39 year old, pregnant women in their second or third trimester of pregnancy
      (from 14 weeks of gestation to 33 weeks/6 days gestation, inclusive) and 60 healthy 18-39
      year old non-pregnant controls. Study subjects will be randomized 1:1:1 to receive one of the
      following three 2010-2011 seasonal inactivated trivalent influenza vaccines: Fluarix®,
      Agriflu®, or Fluzone® (60 pregnant women and 20 non-pregnant women per group). The study will
      begin enrollment when at least 2 of the 4 study products are available. Once enrolled, a
      blood sample will be collected and each subject will receive a single 0.5 mL dose of the
      assigned vaccine. Subjects will be observed for at least 15 minutes after immunization, and
      the subjects will maintain a memory aid to record oral temperature and systemic and local
      adverse events (AEs) for 8 days after immunization. Subjects will have a phone call on Day 2
      and 8 for review of memory aid, concomitant medication assessment, and assessment of AEs. At
      approximately Day 28 post-vaccination, subjects will return to the clinic for blood sample
      collection, AE and concomitant medication assessment, and a targeted physical examination (if
      indicated). Pregnant subjects will also have scheduled phone calls from Day 28 until the time
      of delivery or Day 180, whichever is later, to assess for any new-onset chronic medical
      conditions, and pregnancy-related problems such as miscarriage or serious adverse events
      (SAEs) since the last visit. At approximately Day 180 post-vaccination, subjects will return
      to the clinic for blood sample collection and assessment of the receipt of any vaccines since
      the last visit. Subjects will be asked about any new-onset chronic medical conditions, SAEs
      since the last visit and pregnancy-related problems such as miscarriage (for the pregnant
      women cohort). The duration of the study will be approximately 6 months for the non-pregnant
      subjects and about 6-8 months for the pregnant subjects, depending on delivery date for the
      pregnant women. Pregnant subjects will have collection of maternal and cord blood at the time
      of delivery. Pregnant subjects will also have a phone call 1 month after delivery to assess
      for any new-onset chronic medical conditions or SAEs since the last visit. The primary
      objectives are to evaluate the safety of a single 0.5 mL intramuscular injection of the
      2010-2011 inactivated TIV in pregnant women and to evaluate the immunogenicity of the
      2010-2011 inactivated TIV in pregnant women by hemagglutination inhibition assay (HAI). The
      secondary objectives are to evaluate the persistence of antibodies to the 2010-2011
      inactivated TIV in pregnant women at Day 180 and to assess the transfer of maternally derived
      antibody against viruses in the 2010-2011 inactivated TIV to infants bor
    

Intervention name(s): Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.; Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber..; Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone®, Agriflu® and Fluarix® do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pregnant, women, influenza, vaccine