Novartis H1N1 Vaccine in Pregnant Women
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in
      pregnant women and to determine how their body reacts to different strengths of the vaccine.
      Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the
      response to the vaccine in pregnant women is the same or different than in non-pregnant
      women, the study also includes a group of women who are not pregnant for comparison.
      Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study
      procedures include physical exams, several blood samples and maintaining a memory aid to
      document daily temperature and side effects for 8 days following vaccination. Participants
      will be involved in study related procedures for about 6 months.
    

Detailed description: 
      Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause
      of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many
      countries around the world, prompting the World Health Organization to declare a pandemic on
      June 11, 2009. Pregnant women are at an increased risk for serious consequences of influenza
      infection. A 15 microgram (mcg) dose of unadjuvanted inactivated H1N1 vaccine is recommended
      for healthy adults and recent preliminary data indicates this dose is likely to be protective
      for pregnant women. However, a higher dose of an unadjuvanted, inactivated influenza H1N1
      vaccine may be necessary to confer optimal protection to this at risk population. This
      protocol will explore the antibody response following vaccination of pregnant women at 2
      different dose levels (15 mcg and 30 mcg) and a non-pregnant control group receiving a 15 mcg
      dose. Antibody responses will be assessed at 21 days and 180 days post vaccination. For
      pregnant women, maternal and cord blood will be collected to determine the level of H1N1
      antibodies transferred to the baby. An optimal immune response in pregnant women would impact
      transplacental transport of protective antibodies which is important since vaccines are not
      available for infants younger than six months, another at risk population for severe H1N1
      disease. Sustained immunity for at least 6 months post-vaccination would impart benefit not
      only to the woman herself but also decrease a primary exposure risk (infected mother) for the
      newborn infant. Furthermore, a systematic evaluation of the kinetics of maternally
      transferred antibodies to 2009 H1N1 influenza virus will help improve and develop strategies
      to protect infants from influenza. This is an open label, Phase II study in pregnant and
      non-pregnant women, aged 18-39 years old designed to investigate the safety, reactogenicity,
      and immunogenicity of an inactivated influenza H1N1 virus vaccine. Pregnant women will be
      randomized into 2 groups (100 per dose group) to receive intramuscular (IM) inactivated
      influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). A non-pregnant control group
      of 100 subjects will receive IM inactivated influenza H1N1 vaccine at 15 mcg (Group 3).
      Following immunization, safety will be measured by assessment of adverse events (AEs) through
      21 days post vaccination (serious AEs and new-onset chronic medical conditions monthly
      through 6 months post vaccination (Day 180). Reactogenicity to the vaccine will be assessed
      for 8 days following vaccination (Day 0-7). Immunogenicity testing will include
      hemagglutination inhibition assay (HAI) and neutralizing antibody testing on serum obtained
      on Days 0, 21, and 180. For the pregnant groups, HAI antibody testing will also be performed
      on serum from the participant at delivery, on serum from cord blood collected at delivery
      and, when possible, on serum samples collected from the participant at day 180 and from the
      infant at 6 weeks, four months, or six months after delivery. The primary safety objective is
      to assess the safety of unadjuvanted, inactivated H1N1 influenza vaccine in pregnant women
      when administered at the 15 mcg or 30 mcg dose. The primary immunogenicity objective is to
      assess the antibody response to unadjuvanted, inactivated H1N1 influenza vaccine in pregnant
      women when administered at the 15 mcg or 30 mcg dose. The secondary objective for pregnant
      women is to assess the efficiency of placental transport of maternal influenza antigen
      specific antibodies to the neonate.
    

Intervention name(s): Inactivated H1N1 Vaccine
Intervention type(s): Biological
Intervention description(s): H1N1 vaccine [Influenza A (H1N1) 2009 Monovalent Vaccine] is a licensed, inactivated influenza virus vaccine. It will be provided as prefilled single dose syringes containing 0.5 mL. The 0.5 mL prefilled syringe is formulated without preservative. The 15 microgram (mcg) dose will be administered as a single 0.5 mL intramuscular (IM) injection in the deltoid muscle of the preferred arm. The 30 mcg dose will be administered as two 0.5 mL injections in the deltoid muscle of each arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H1N1, influenza A viruses, vaccine, pregnant women